p.1 

OAR Box 1165 

Prepped by Ollie Stewart 

Document Number: 

253) F.R April 15, 

Docket Number: 

A-90-07 

Printed 4/28/2008 11:52:23 AM 

1992 

Sheet 253 of 257 
P.2 

A-qO-Of 

Wednesday 

April 15, 1992 

Part II 

Environmental 

Protection Agency 

s 40 CFR Part 79 

Fuels and Fuel Additives Registration 

Regulations: Proposed Rule 
13168 Federal Register /'Vol. 57, No.- 73 / Wednesday; April 15, 1992, / Proposed-Rules 

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ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 79 

[FRL-4121-4] 

Fuels and Fuel Additives Registration 

Regulations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This notice presents 

proposed regulations for the registration 

of motor vehicle fuels and fuel additives 

as authorized by sections 211(b)(2) and 

211(e) of the Clean Air Act (CAA). 

Under die proposed regulations, 

producers of motor vehicle fuels and 

fuel additives would be required to 

conduct certain tests and submit 

information regarding the composition 

of emissions produced by such fuels and 

fuel additives and the effects of these 

emissions on the public health and 

welfare. Additional provisions for 

determining the effects of fuels and 

additives on the performance of 

vehicular emission control devices 

would be coordinated with existing and 

future rules under section 211(f). The 

proposal includes a grouping system and 

other mechanisms designed to avoid 

duplicative efforts and reduce the costs 

of testing by producers of fuels and fuel 

additives. ; 

The proposed regulations would 

supplement existing registration 

requirements, and would potentially 

apply to both current and future fuels 

and additives. The proposed new 

requirements are designed to provide a 

body of information that would assist 

EPA in evaluating die potential adverse 

effects of various types of fuels and fuel 

additives and in determining whether 

futher risk assessment or regulatory 

action is needed under section 211(c). 

DATES: Written comments on this Notice 

of Proposed Rulemaking (NPRM) will be 

accepted until June 30,1992. A public 

hearing will be held May 28,1992 at 9 

a.m. It will be extended to May 29, if 

necessary, but prospective presenters 

should be prepared to testify on the first 

day. 

ADDRESSES: Comments on the NPRM 

should be submitted in duplicate to: EPA 

Air Docket (LE-131): Attention: Docket 

No. A-90-07; U.S. Environmental 

Protection Agency, room M-1500, 401 M 

Street SW., Washington, DC 20460; 

phone (202) 382-7548. This docket is 

located at the above address on the first 

floor of Waterside Mall and is open for 

public inspection weekdays from 8:30 

a.m. to 12 noon and from 1:30 p.m. to -

3:30 p.m. As provided in 40 CFR part 2, a 

reasonable fee may be charged by EPA 

for copying services. The public hearing 

will be held in Ann Arbor, Michigan at 

the Ann Arbor Regent—Best Western 

Domino's Farms Hotel and Conference 

Center. 3600 Plymouth Road (U.S. 23 at 

Plymouth Road); phone (313) 769-9800. 

FOR FURTHER INFORMATION CONTACT: 

Mrs. Carolyn Krueger, SDSB12, 

Regulation Development and Support 

Division, U.S. Environmental Protection 

Agency, 2565 Plymouth Road, Ann 

Arbor, MI 48105; phone (313) 668^274. 

Persons who wish to receive a copy of 

the regulatory text for this proposed rule 

(including the proposed healdi testing 

guidelines) should leave a message, 

including their name, complete mailing 

address, and telephone number, at (313) 

668-4361. The proposed regulatory text 

is also available in the public docket 

referenced above. 

SUPPLEMENTARY INFORMATION: 

I. Public Hearing 

Any person interested in presenting 

testimony at die public hearing should 

notify the contact person listed above at 

least seven days prior to the day of the 

hearing. The notification should include 

the estimated time required for the 

presentation and identification of audio/ 

visual equipment needs, if any. A signup sheet will be available at the 

registration table the morning of the 

hearing for scheduling the order of 

testimony. It is suggested that sufficient 

copies of the statement and other 

presentation materials be brought to the 

hearing for distribution to the audience. 

All materials submitted will be made 

part of the official record for this 

rulemaking. 

Mr. Richard D. Wilson, Director of die 

Office of Mobile Sources, has been 

designated as presiding officer for the 

hearing. The hearing will be conducted 

informally, and technical rules of 

evidence will not apply. Written 

transcripts of the proceedings will be 

made by a court reporter. Copies will be 

available for examination in the public 

docket or for purchase by individual 

arrangement with the court reporter. 

II. Background 

A. Introduction 

Over 2,200 fuels and 4,100 fuel 

additives are currently registered with 

EPA and, to some degree, each of them . 

produces emissions which may 

contribute to potentially harmful air 

pollution in the United States. The 

primary purpose of this proposed 

rulemaking is to establish registration 

requirements which will provide 

information for identifying and 

evaluating the potential adverse air 

pollution effects of motor vehicle fuels 

and fuel additives and for guiding the 

direction of related regulatory actions in 

the future. 

The remainder of this section reviews 

the statutory history of this proposed 

rulemaking, summarizes the public 

comments received in response to the 

Advanced Notice of Proposed 

Rulemaking, and defines certain key 

terms used in later discussion. The 

overall scope of the program is 

described in section III. Section IV 

outlines the objectives, rationale, and 

implementation of the proposed 

grouping system for fuels and additives. 

Issues germane to the generation of 

fuel/additive emissions for subsequent 

testing are discussed in section V, and 

proposed requirements for evaluating 

the effects of fuels and additives on the 

public health and welfare are described 

in section VI. Section VII outlines the 

proposed reporting requirements for the 

program. Subsequent sections discuss 

special program provisions, compliance 

considerations, confidentiality issues, 

public participation, and administrative 

topics. 

B. Statutory History 

Section 211(a) of the Clean Air Act 

(CAA). 42 U.S.C. 7545. authorizes EPA to 

designate any motor vehicle fuel or 

additive and prohibits producers of 

designated fuels or additives from 

selling such products unless they have 

been registered by EPA in accordance 

with section 211(b). The basic data 

elements which producers of fuels and 

additives must submit for purposes of 

registration, as stipulated by section 

211(b)(1). include commercial identifying 

information, range of concentration, 

purpose-in-use, and chemical 

comppstion. EPA issued regulations 

implementing this provision in 1975 (40 

CFR part 79). 

The 1970 CAA also provided EPA 

with discretionary authority to establish 

additional requirements for fuel and fuel 

additive registration. According to 

section 211(b)(2), EPA "may also 

require" producers "to conduct tests to 

determine potential public health effects 

of such fuel[s] or additive[s] (including, 

but not limited to, carcinogenic, 

teratogenic, or mutagenic effects)," and 

to furnish other "reasonable and 

necessary" information to identify fuel 

and fuel additive emissions and 

determine their effects on vehicular 

emission control performance and on 

the public health and welfare. The 

statute further stipulates that testing for 

health effects is to be conducted 
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^Federal Kegister /;Vol.-57. Nol 73'/ Wednesday, April 15, 1992 / fropbsed'Rales :

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according to procedures and protocols 

established by the Administrator, and 

that test results will not be considered 

confidential. When die producer has 

submitted the required information and 

has given assurances diat the Agency 

will be notified of future changes in that 

information, section 211(b)(3) directs tiie 

Administrator to grant registration to 

the fuel or additive. 

EPA did not exercise its discretionary 

authority to require fuel and additive 

testing under section 211(b)(2) when die 

general registration regulations under 

section 211(b)(1) were issued in 1975. 

However, in the CAA Amendments of 

1977 (Pub. L 95-95, August 7,1977), 

Congress added section 211(e) to the 

statute, which made implementation of 

section 211(b)(2) mandatory and 

contained additional provisions 

concerning the implementation of the 

statute. 

Section 211(e)(1) requires 

implementation of the section 211(b)(2) 

authority within one year of enactment 

of the 1977 amendments. In an effort to 

fulfill this requirement, EPA published 

an Advanced Notice of Proposed 

Rulemaking (ANPRM) in 1978 (see 43 FR 

38607, August 29,1978; Docket ORD-78-

01); however, die rulemaking did not go 

forward during the next ten years. 

Nevertheless, this action has remained 

on the EPA regulatory agenda, and a 

development plan for the rulemaking 

was created in 1988. 

C. Recent Events and Agency Actions 

In 1989, a citizens group brought a 

lawsuit {Thomas v. Reilly, CA- No. 89-

6269 [D. Oreg. 1989]) challenging EPA's 

failure to promulgate fuel and fuel 

additive testing regulations widiin the 

one-year time limit permitted by CAA 

section 211(e). EPA entered into a 

consent decree in settlement of this 

lawsuit without adjudication of any 

issue of fact or law. The consent decree, 

which was signed by tiie Court, required 

that the EPA Administrator sign an 

advance notice of proposed rulemaking 

by August 1,1990, a notice of proposed 

rulemaking by January 1,1992, and a 

final rule by June 1,1993. The decree did 

not address "the substance of the 

rulemaking," nor did it "limit or modify 

the discretion accorded * * * by section 

211 * * * or general principles of 

administrative law in any fashion". By 

agreement with the plaintiff, the NPRM 

signature deadline was later extended to 

April 1,1992. 

The Agency published the required 

ANPRM on August 7.1990 (55 FR 32218). 

A public hearing was held on September 

26,1990, followed by a 30-day period for 

written commentary. Public reponse 

included four oral presentations at the 

hearing and the subsequent submission 

of 24 written comments. 

To gain further public involvement in 

the rulemaking, the Agency engaged the 

services of a private consultant group to 

assess the feasibility and 

appropriateness of applying regulatory 

negotiation procedures (under the 

provisions of section 583 of the 

Negotiated Rulemaking Act of 1990) to 

the development of the section 211 

regulations. During the months of March 

and April, 1991, the consultants 

interviewed representatives of a variety 

of affected industry groups and 

environmental organizations to gauge 

their level of interest in the program and 

their willingness to participate in 

potential negotiations. These parties 

were also invited to a meeting in 

Washington, DC on May 2,1991. to 

discuss the program issues further and 

to explore the potential advantages and 

disadvantages of a formal regulatory 

negotiation process. Susbsequently, the 

meeting attendees were polled again 

about their willingness to enter 

negotiations. The results indicated that 

there was insufficient support among a 

number of key parties, and EPA thus 

decided not to convene a regulatory 

negotiation for this proposed 

rulemaking. 

D. Summary and Analysis of Comments 

1. Program Focus and Jurisdictional 

Issues 

The overall focus and scope of the 

potential new registration requirements 

were frequent topics of public comment 

received in response to the ANPRM. 

With respect to provisions in section 211 

concerning the public health and. 

welfare impacts of fuels and fuel 

additives, nearly all respondents 

recognized that information and testing 

requirements related to fuel and 

additive emissions were mandated by 

the statute. However, not all 

respondents agreed about the propriety, 

necessity, and desirability of 

requirements for the conduct of tests on 

the "raw" (i.e., uncombusted liquid) 

fuels and additives themselves. The 

majority maintained that the underlying 

objectives of the Clean Air Act and the 

specific language of section 211 would 

best be met by restricting the focus of 

the regulations to fuel and fuel additive 

emissions. According to these 

respondents, requirements addressing 

the potential adverse effects of "raw" 

fuels and additives would not help to 

elucidate the sources and effects of air 

pollution, and would thus fall outside 

the scope of the statute. A few 

commenters held the opposite point of 

view, arguing for broad and 

comprehensive health testing of fuels 

and additives in their original liquid 

formulations as well as in the 

combusted and vaporized states. 

As discussed more fully in section 

III.B of this NPRM, EPA believes that the 

Agency has some discretion under 

section 211 to determine the focus of fuel 

and additive evaluation requirements. 

Consistent with the goals of the CAA, 

EPA has decided to focus this proposed 

rulemaking on the emissions-based 

effects of fuels and fuel additives. Thus, 

the proposed health effects testing 

provisions specifically address the 

effects of inhalation exposure to fuel 

and additive emissions, inculding both 

evaporative and combustion emissions. 

Tests to determine the direct toxicity of 

"raw" fuels and additives (e.g., by oral 

or dermal exposure) are not included 

except insofar as such information may 

be heeded to determine the effects of 

their emissions. The Agency believes 

this focus to be compatible with the 

intent of Congress and the scope of 

authority granted by section 211. 

Focusing today's proposed rulemaking 

on the emissions of fuels and fuel 

additives will also serve to relieve 

concerns about possible areas of 

overlap between section 211 and other 

Federal regulatory programs. Existing 

authority under the Toxic Substances 

Control Act (TSCA). 15 USC section 

2601 et seq., has often been cited in this 

regard. TSCA provides EPA authority to. 

examine the potential environmental 

and health risks associated with 

chemical substances or mixtures, and 

several respondents felt that 

promulgation of the health effects 

testing provisions in section 211(b) 

would be duplicative of the regulatory 

mechanisms already in effect under 

TSCA. While rejecting the notion that 

TSCA might eliminate the need for 

implementation of section 211(b), EPA 

recognizes the need for coordination 

between the two programs. 

To a large extent, the potential 

overlap between TSCA and section 211 

is more legalistic than programmatic, 

and need not result in overlapping 

regulations. Because of the technical 

difficulties associated with testing 

complex mixtures, the TSCA program 

has traditionally focused on the toxicity 

of discrete chemcial substances rather 

than on complex mixtures such as fuels 

and additives. In fact, under the 

Premanufacturing Notification process 

implemented for new chemical review, 

TSCA excludes chemical mixtures 

except those which occur in nature. 

Moreover, under both CAA and TSCA 

programs, persons may submit existing 

data to fulfill regulatory requirements 
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13170 Federal Register / Vol..$7, No. 73 / Wednesday, April 15. 1992 / Proposed Rules 

and are not required to submit 

duplicative data. Nevertheless, some 

individual chemicals used in fuel and 

additive formulations have been subject 

to review and testing under TSCA. 

EPA's plan to limit the focus of section 

211 regulations to emmissions-based 

effects will help to avoid the possibility 

that such activities under TSCA might 

overlap with testing requirements 

promulgated under section 211(b). 

Concerns about potential regulatory 

overlap were also raised in conjunction 

with the mobile source-related air toxics 

provisions added by the 1990 CAA 

Amendments (CAA Section 202(1)). 

Section 202(1) requires that EPA 

complete a study of the need for and 

feasibility of controlling unregulated 

toxic air pollutants associated with 

motor vehicles and fuels. Based on this 

study, EPA must promulgate vehicle or 

fuel standards to control mobile source 

emissions of benzene and formaldehyde. 

At EPA's discretion, other toxic 

pollutants may also be controlled. 

In the opinion of some respondents, 

EPA's informational objectives in regard 

to the air pollution effects of fuels and 

additives would be better served by the 

air toxics provisions of section 202(1} 

than by the health and environmental 

provisions of section 211(b). According 

to this view, section 202(1) mandates a 

more direct approach, focusing on 

specific mobile source air pollutants 

which represent die greatest risk to 

human health and requiring the 

identification of currently unregulated 

mobile source pollutants which should 

be subject to control. 

While acknowledging that the two 

parts of the CAA share a general 

concern about the public's exposure to 

toxic chemicals produced by mobile 

sources, EPA believes that tiiey can 

complement rather than duplicate or 

supplant one another. Section 202(1) 

addresses the toxic emissions 

themselves, while section 211(b) focuses 

on the components and effects of 

emissions generated by particular motor 

vehicle fuels and additives. The required 

study under section 202(1) may or may 

not identify any fuel-related causes of 

toxic air pollutants, while the testing 

required under section 211(b) will 

provide such information. This should 

prove useful in EPA decisionmaking 

regarding the need for feasibility of 

additional vehicle or fuel regulations to 

reduce toxic emissions. Furthermore, a 

different regulatory approach underlines 

each of the two statutes. Section 20201 

seeks to detennine the extent to whioh 

existing toxicologic data on specific 

identified air pollutants warrants 

additional regulation, and requires 

certain EPA actions in this regard by 

rwd-1995. The purpose of the current 

Rulemaking is to establish testing 

requirements that will provide EPA with 

adequate information on the emissions 

effects of existing and future fuels and 

additives to determine whether the 

commercial distribution or use of any 

such fuels or additives should be 

controlled. 

2. Emission Control System Testing 

Several respondents representing 

segments of the vehicle and engine 

manufacturing industries favored 

iagorous requirements for testing the 

potential effects of fuels and fuel 

additives on vehicular emission control 

performance. These respondents 

maintain that emission control test 

requirements under this rulemaking 

sheuld involve different driving cycles 

fer urban vehicles, tractor trailers, and 

alternatively fueled vehicles, and should 

include such parameters as long-term 

durability, deterioration rate, wear, 

coBrosion, deposition, and compatibility 

with a variety of lubricating oil 

formulations. Furthermore, they argued 

tfea* test requirements for existing 

products should be just as stringent as 

those required for the market entry of 

new fuels and additives, and that the 

effects of each fuel or additive on 

emission control performance should be 

tested in a statistically significant 

sample of engines. 

IPA recognizes the concerns of these 

respondents regarding the potential 

impact of fuel and/or additive 

formulations on emission control system 

integrity. On the other hand, it is not in 

the public interest to establish 

registration requirements so onerous 

that tiiey would discourage the 

introduction of beneficial new additives 

ani alternative fuels. 

IPA believes that the existing 

prohibitions in section 211(f) have 

avoided these unfavorable results while 

preventing tiie introduction of fuels and 

additives which would significantly 

degrade the performance of emission 

cofttrol equipment. In effect, these 

mechanisms call for emission control 

testing of fuels and additives only when 

their composition departs significantly 

from tiie general range of fuel 

formulations which would ordinarily be 

anticipated by manufacturers of motor 

vehicle engines and emission control 

devices. This objective has been 

accomplished by the issuance of 

interpretive udes which lay out specific 

chemical and physical criteria for a 

category of fueis and additives 

considered "substantially similar" to 

certification gasoline fuels (46 FR 38582 

and 56 FR 5352). Products which meet 

these "sub sim" criteria can be placed in 

commercial use without first undergoing 

testing to determine their potential 

emission control impact. Conversely, 

manufacturers of fuels and additives 

which do not conform to the "sub sim" 

criteria are required to apply for a 

waiver of section 211(f) restrictions. This 

process requires the waiver applicant to 

demonstrate, through testing if 

necessary, that such products do not 

decrease the ability of vehicular 

emission control systems to comply with 

emission standards. 

Section 211(f) was passed by 

Congress in 1977,. seven years after 

enactment of the section 211(b) 

provisions which are the primary 

subject of today's proposed rulemaking. 

In EPA's judgment, the mechanisms 

already implemented under section 

211(f) are adequate to satisfy the section 

211(b) requirement for testing to 

determine the effects of fuels and 

additives on emission control systems. 

Three factors must be considered in this 

regard: (1) The adequacy of test 

procedures conducted for the purpose of 

waiver applications under section 211(f), 

(2) the adequacy of existing "sub sim" 

criteria for determining which fuels and 

additives must apply for a section 211(f) 

waiver, and (3) the scope of section 

211(f) prohibitions. These factors are 

discussed below. 

(1) Adequacy of testing. While EPA 

believes that the level of emission 

control system testing conducted in 

support of section 211(f)(4) waiver 

requests has generally been appropriate 

and effective, the comments summarized 

at the. beginning of this subsection 

indicate that some industry segments 

consider such testing inadequate for 

determining the potential impact of fuels 

and additives on emission control 

devices. To the extent that more 

comprehensive or standardized 

emission control test requirements might 

be needed, EPA believes they should be 

implemented as changes to the existing 

waiver application procedures under 

section 211(f) rather than as new, 

overlapping regulations under section 

211(b). While such revisions are outside 

the scope of the proposed rulemaking, 

EPA would separately welcome 

suggestions regarding possible changes 

in conjunction with section 211(f). 

(2) Adequacy of "substantially 

similar" criteria. In EPA's view, more 

than a decade of experience has 

demonstrated the practical value of the 

"substantially similar" concept for 

determining whether a fuel or additives 

needs to be tested for its effects on 

emission control equipment. Among 

gasoline fuels and their related bulk 
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Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rxiles 13171 

additives (the only fuel/additive 

categories subject to section 211(f) 

prohibitions prior to the 1990 CAA 

Amendments), EPA is not aware of 

instances in which products excused 

from testing because they met "sub sim" 

criteria were later discovered to have 

adverse effects on vehicular emission 

control performance. Rather than 

tightening up the criteria, the Agency 

has been persuaded by practical 

experience in conjunction with the 

waiver application process to publish a 

revision of the "substantially similar" 

definition, which raised the limitation on 

the amount of oxygen permitted in 

formulations considered to be "sub 

sim". 

(3) Scope of section 211(f) 

prohibitions. Until the 1990 CAA 

Amendments went into effect, the 

statutory language of section 211(f) was 

interpreted as applying only to unleaded 

gasoline fuels and related bulk 

additives. Interpretive rules establishing 

the criteria for fuels and additives 

considered to be "substantially similar" 

to certification fuels thus were published 

only for products in the unleaded 

gasoline category. With enactment of 

the 1990 CAA Amendments, all types of 

motor vehicle fuels and additives were 

placed under section 211(f) jurisdiction. 

Proposed criteria for fuels and additives 

considered "substantially similar" to 

diesel fuel have now been published (56 

FR 24362-3. May 30,1991). In addition, 

"sub sim" criteria appropriate to other 

fuel/additive categories are now under 

development or planned for all fuels 

(other than leaded gasoline) for which 

certification procedures and emission 

standards exist. 

However, the expanded scope of 

section 211(f) applies only to products 

first introduced into commerce on or 

after November 15,1990, the effective 

date of the CAA Amendments. 

Consequently, a large number of 

products introduced and/or registered 

prior to this date will still fall outside 

the regulatory domain of section 211(f). 

These "grandfathered" products include 

aftermarket additives sold for use in 

gasoline-powered vehicles, as well as all 

non-gasoline fuels and fuel additives, 

introduced prior to the 1990 CAA 

Amendments. If these products are to be 

subject to possible testing requirements 

and regulatory control on the basis of 

their potential emission control effects, 

the statutory authority has to derive 

from sections 211(b) and (c) rather than 

section 211(f). 

The possibility that some 

grandfathered products may have 

deleterious effects on emission control 

performance is addressed in the 

proposed rulemaking as follows. In 

general, section 211(b) provisions 

relating to emission control system 

testing are integrated with the 

regulatory structure of section 211(f). 

Products not subject to section 211(f) 

because they were first introduced prior 

to the effective date of the applicable 

prohibition would not routinely be 

required to undergo emission control 

testing. However, the proposed 

rulemaking provides a mechanism by 

which EPA can choose to require testing 

for such grandfathered products, similar 

to the testing which a waiver applicant 

would have to conduct, if so petitioned 

by outside parties or if other information 

available to the Agency indicates that 

such review is appropriate. This topic is 

further discussed below in section III.D. 

3. Grouping Provisions 

The ANPRM discussed EPA's intent to 

develop a grouping system by which 

manufacturers of similar fuels and 

additives could voluntarily pool their 

efforts and resources to satisfy program 

requirements. According to this plan, 

fuels and additives would be grouped 

according to criteria specified by EPA. 

Representatives from each group would 

then be selected for testing, with the test 

results and attendant costs shared by 

the participating manufacturers. As a 

result, both costs and duplicative efforts 

would be reduced. 

Public comment about the grouping 

concept was generally supportive. 

However, at least one respondent 

pointed out that participation in 

cooperative testing arrangements would 

not be a viable option for makers of 

proprietary specialty fuel additives, 

because valuable trade secrets about 

product formulations would have to be 

revealed to potential competitors. EPA 

acknowledges that the opportunity for 

group participation will be most 

attractive to manufacturers of generic or 

commodity-type products. On tiie otiier 

hand, there are a number of approaches 

under which group participation may 

not require detailed chemical 

formulations to be divulged. For 

example, persons could use an agent, 

such as an accouting firm or a trade 

association, to coordinate testing and 

represent the group to EPA while 

preserving the anonymity of the other 

members in the group. Manufacturers of 

specialty products will have to judge for 

themselves whether the ampunt of 

confidential business information that 

must be revealed in order to participate 

in group testing arrangements is 

acceptable to them. 

In regard to the development of. 

criteria for establishing the groups, a 

number of respondents suggested that 

fuels and fuel additives be grouped 

according to their emission components. 

EPA agrees that emissions-based 

grouping would be ideal, but until this 

rulemaking has gone into effect, the 

requisite information on emission will 

not be available. Recognizing this 

problem, some respondents suggested 

that EPA first collect emissions data 

from fuel and additive manufacturers 

and then develop the grouping criteria. 

However, to follow this suggestion 

would necessitate two separate 

regulatory proceedings: A preliminary 

rule requiring manufacturers to submit 

the results'of emission speciation 

procedures and a second rule creating 

an emissions-based grouping system 

and promulgating regulations to 

implement all of the other program 

requirements. This is not a viable 

alternative for the Agency, given the 

time constraints of the statute and the 

provisions of the Consent Decree. 

Therefore, the grouping system proposed 

here is based on the composition of raw 

fuels and additives, with the underlying 

assumption that fuels and additives with 

similar raw constituents will generate 

similar emissions. 

Some respondents submitted specific 

suggestions to EPA concerning the 

definition of fuel and additive groups. 

For example, one respondent proposed 

that fuels be subdivided for health 

testing on the basis of their octane 

number and/or PONA number 

(paraffins, olefins, naphthenes, and 

aromatics). EPA has not found these 

numerical indexes useful for 

distinguishing meaningful health effects 

testing groups. Moreover, the 

significance of the associated 

hydrocarbon proportions in the raw fuel 

state will be reduced in the case of the 

exhaust emission by the "homogenizing" 

effect of the combustion process. 

Nevertheless, recent evidence suggests 

that varying the relative olefin and/or 

aromatic content of a fuel may impact 

the concentration of some emission 

components. Thus, olefin and aromatic 

content are among the parameters under 

consideration by EPA for defining 

groups or selecting group 

representatives for testing. 

Opinions differed among respondents 

about the usefulness of the section 211(f) 

"substantially similar" criteria in the 

context of a grouping system for fuel 

and additive health testing. As 

previously described, the "sub sim" 

criteria currently serve to designate 

which fuels and fuel additives must 

obtain a waiver of section 211(f) 

prohibitions. While some respondents 

endorsed the incorporation of existing 

"sub sim" criteria into the grouping 
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13172 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

system for health effects testing, others 

felt that the resulting "sub sim" group 

would be too broad to allow the health 

test results obtained for selected 

representatives to be generalized to the 

group as a whole. 

EPA believes that, in most respects, 

the "sub sim" criteria (56 FR 5352, 

February 11,1991) are useful 

determinants of "baseline" conventional 

fuels and fuel additives (see section IV 

of this NPRM). The established criteria 

restrict the elemental composition of 

"sub sim" formulations to carbon, 

hydrogen, oxygen, nitrogen, and sulfur, 

with limits placed on the amount of 

methanol, oxygen, sulfur, and certain 

other substances. However, EPA is 

considering several variants of these 

criteria for distinguishing between 

"baseline" and "non-baseline" 

formulations. Extreme concentrations of 

aromatics and olefins are two possible 

distinguishing characteristics. A 

different restriction on the amount of 

oxygen permitted in baseline 

formulations is another possibility. The 

oxygen restriction for "sub sim" fuels is 

currently 2.7 percent by weight (and 

somewhat higher for certain waivered 

fuels and additives), and this may be 

appropriate for defining baseline 

formulations in this proposed program. 

However, EPA is also considering 

restricting baseline formulations to 

those with less than 1.5 weight percent 

of oxygen. In the latter case, 

"reformulated" fuels would be excluded 

from the "baseline" classification. This 

would result in the generation of more 

explicit information for various 

oxygenated gasoline fuels. 

4. Health Effects Testing Provisions 

A number or respondents argued that 

an overly stringent and expensive health 

effects testing program would be counter 

to the public interest They pointed out 

that unreasonably high costs of program 

compliance would discourage the 

development of new fuels and additives 

and would reduce the availability of 

products potentially beneficial to the 

public health and welfare. While the 

testing program must provide adequate 

information for assessing the toxicity of 

fuels and additives, EPA is well aware 

of the importance of striking an 

appropriate balance between scientific 

demands and technical and financial 

constraints, taking into account both the 

need for adequate information and the 

need for continued innovation. The 

Agency believes that the program 

outlined in the proposed rulemaking is 

consistent with the statute and reflects a 

reasonable and cost-conscious approach 

to a very complex regulatory area. 

In comments directed at the health 

assessment approaches described in the 

ANPRM, respondents urged EPA to 

include provisions for taking relevant 

existing information into account, to use 

a tiered testing approach as a means for 

identifying products which should 

undergo long-term study, and to take 

advantage of existing standardized test 

guidelines whenever possible. These 

suggestions are reflected in today's 

proposed rule. 

Some respondents stated that 

successful implementation of a broadlybased health effects testing program 

was doubtful in view of the many 

technical problems which must first be 

overcome. They maintained that years 

of testing would be required to validate 

test protocols and establish baseline 

data, in view of the chemical complexity 

of fuel and additive formulations and 

the impact of vehicle choice, engine 

type, emission control technology, and 

operating conditions on the composition 

of emissions. 

EPA is well aware of these technical 

difficulties, but does not agree that they 

are insurmountable. Today's proposed 

rule contains a number of proposals for 

bringing the sources of variability under 

reasonable control, including rules for 

the selection and operation of vehicles 

and equipment, base fuel specifications 

for each major fuel/additive family, 

standardized procedures for the 

generation, sampling, and storage of 

emissions, and guidelines for animal 

inhalation exposure testing. Together 

with experimental control requirements, 

these measures should reduce the 

testing program's inherent variability to 

acceptable limits. EPA invites comments 

from the public on the adequacy of these 

measures and on ways to improve them. 

Many commenters urged EPA to "set 

priorities" for testing among the large 

universe of motor vehicle fuels and fuel 

additives potentially subject to the 

proposed rulemaking. However, there 

was little agreement about which 

specific formulations or product 

categories—fuels vs. additives, 

conventional vs. reformulated vs. 

alternative fuels—should be placed high 

and low on the priority list. Under 

section 211, Congress has mandated that 

EPA enact a scheme for testing that 

would generally and reasonably assess 

the health risks of all fuels and fuel 

additives. Therefore, EPA has proposed 

a grouping system which provides an 

efficient mechanism for obtaining 

information on all types of fuels and 

additives. A system of evaluation tiers 

has also been developed, enabling EPA 

to determine whether more definitive 

testing is needed for any particular fuels 

or additives (or types of fuels and 

additives) based upon toxicity and 

exposure data obtained from the 

literature, from modeling techniques, 

and from a battery of screening tests. 

Finally, EPA intends, under section 

211(e)(3)(C), to recognize existing 

adequate data as compliance with the 

rule. 

Related comments were submitted 

regarding the applicability of program 

requirements to fuel additives which are 

considered "substantially similar" to 

conventional fuels. Some respondents 

pointed out that when a "sub sim" 

additive is mixed with gasoline it is 

extremely difficult if not impossible to 

differentiate from the fuel itself, and that 

efforts to detect the negligible 

contribution of such an additive to the 

emissions produced by the gasoline/ 

additive mixture would be futilei Thus, 

according to these respondents, "sub 

sim" fuel additives should be exempt 

from program requirements. 

EPA agrees with some of the 

reasoning behind these arguments. The 

public health and welfare provisions in 

this rulemaking are concerned with the 

impact of emissions generated by fuels 

and fuel additives in normal use. Since 

additives are properly used only in 

conjunction with their associated fuels, 

program requirements pertaining to the 

potential effects of additives are focused 

specifically on the emissions of the 

respective fuel/additive mixtures. For 

additives with essentially the same 

chemical makeup as their parent fuels, 

currently available technology will 

generally not be capable of 

differentiating the emission products of 

the additive/fuel mixture from the . 

emission products of the parent fuel 

itself. 

EPA does not agree, however, that the 

manufacturer of an additive should be 

relieved of registration responsibilities 

just because ofthe additive's similarity 

to its parent fuel. Instead, provisions 

within the proposed grouping system 

should be able to account for these 

relationships. Such mechanisms are 

discussed further in section IV, below. 

5. Small Business Provisions 

Under section 211(e), EPA is 

authorized to create special program 

allowances and/or exemptions which 

would reduce the burdens of program 

compliance for small businesses. If EPA 

should choose to exercise this authority, 

the operative definition of a small 

business would be specified within the 

associated regulations. Respondents 

who commented on this matter felt that 

any small business definition would be 

arbitrary and unfair. In their view, small 
p.a. 

JFederail Kegister / VoL 67. No. 73 / Wednesday. April 15, 1992 / Proposed Rules 13173 

business provisions could potentially 

place individual manufacturers who 

sold multiple low-volume products at a 

disadvantage relative to single-product 

manufacturers. They also believed that 

the rules governing small business 

allowances could be manipulated by 

large manufacturers, creating loopholes 

never intended by EPA 

While EPA does not necessarily share 

each of the respondents' concerns, this 

NPRM does not contain specific 

proposed provisions for small 

businesses. In general, the proposed 

grouping scheme, tiered testing 

structure, and other general provisions 

should assure that undue burdens are 

not placed upon small businesses. 

Nevertheless, EPA's analysis indicates 

that the costs pf compliance with the 

proposed program may place a few 

small businesses in financial jeopardy. 

EPA is thus attempting to identify the 

characteristics which may make some 

small companies unusually vulnerable 

to the potential financial impact of the 

proposed requirements, and to specify 

fair and appropriate approaches for 

providing cost relief to such companies. 

These topics are discussed further in 

section Vffl.C. 

E.KeyTerma 

A fuel is defined to be any material 

which is capable of releasing energy or 

power by combustion or otiier chemical 

or physical reaction. Only fuels intended 

for use in motor vehicles are included 

under the proposed regulations. 

Currently, fuels intended for use 

exclusively ta off-road vehicles are not 

designated for registration. Both 

domestic and foreign products are 

included in the designation. 

A fuel additive is any substance that 

is intentionally added to a fuel and that 

is not intentionally removed prior to sale 

or use. Bulk additives are products 

which are added to fuel before tiie fuel 

is commercially available for 

introduction into the fuel tank of a motor 

vehicle, whether added at the refinery 

as part of the original blending stream or 

after the fuel ie transported from the 

refinery. Aftermarket additives are. 

products marketed for introduction 

directly into the fuel system of a motor 

vehicle. 

A base fuel is a generic fuel 

formulated from a set of specifications 

' to,represent a given fuel family and used 

in conjunction with the testing pf 

additives in that family. 

Combustion emissions are the exhaust 

products of the combustion of fuel and/ 

or additives in a motor vehicle engine. 

For the purposes of this rulemaking, this 

designation (refers to controlled exhaust 

products (Le.. post-aftertreatment 

tailpipe emissions) unless otherwise 

specified. 

Evaporative emissions are chemical 

compounds emitted into the atmosphere 

by vaporization of tiie components of a 

fuel or additive/fuel mixture. For 

purposes of this rulemaking, the term 

"evaporative emissions" refers both to 

emissions created by vaporization from 

the fuel system of a motor vehicle (hot 

soak, diurnal, and running losses) as 

well as those displaced from the fuel 

tank by incoming fuel during refueling 

operations. 

Atmospheric transformation products 

are compounds formed in the 

atmosphere from the reactions of 

primary emissions such as volatile 

organic compounds (VOCs) in the 

presence of atmospheric gases such as 

nitrogen oxides. The formation of many 

such compounds also requires the 

presence of sunlight Transformation 

products include ozone/formaldehyde, 

peroxylacetyl nitrate (PANJ, and other 

nitrated and oxygenated low molecular 

weight organic compounds. 

III. Program Scope 

A. Overall Purpose and Applicability 

Section 211 of the Clean Air Act 

establishes a framework for registering 

motor vehicle fuels and additives, for 

gathering information about them, and 

for possibly limiting or prohibiting their 

commercial distribution and sale when 

the available information warrants such 

action. Previous regulatory actions have 

implemented sections 211 (a) and (b)(1), 

which govern tiie general registration of 

fuels and additives, as well as section 

211(f), which prohibits the commercial 

introduction of certain fuels and 

additives prior to a demonstration by 

the prospective registrants that these 

products do not adversely affect 

emission control system performance. -

Today's Notice proposes new 

registration requirements for motor 

vehicle fuels and fuel additives under 

sections 211 (b)(2) and (e). Uiese 

sections grant EPA authority to require 

information on the potential health, 

welfare, and emission control system 

effects associated with motor vehicle 

fuels and additives, and to specify 

procedures and protocols to be used by 

fuel and additive producers in 

complying with these requirements. 

The proposed new requirements 

would apply to any motor vehicle fuel or 

additive which is already registered or 

is subject to tiie general registration 

requirements in effect under sections 

211(a) and 211(b)(1). At the present time, 

this designation encompasses both 

current and new gasoline and diesel 

fuels and additives produced and 

commercially distributed for use in 

motor vehicles. Whjle alternative fuels 

and their additives are not yet 

designated for registration, EPA plans to 

designate them before this proposed rule 

becomes final. Currently, fuels and fuel 

additives intended only for off-road 

vehicular use (e.g., in farm and 

construction equipment aircraft, boats, 

and railroad engines) do not need to be 

registered, arid thus are not subject to 

the new registration requirements 

proposed in this rulemaking. However, if 

these fuels and additives are covered 

under future registration requirements, 

this program (modified as needed) 

would extend to them as well. 

By this proposed rule, EPA intends to 

satisfy Congress* mandate under section 

211(e) that EPA implement its authority 

under section 211(b). EPA interprets 

section 211(b) to give it the authority to 

require testing of fuels and fuel 

additives to Identify their health and 

environmental effects. Section 2li(b), 

however, must be read in conjunction 

with section 211(c), which in part gives 

EPA authority to control or prohibit the 

manufacture, introduction into 

commerce, offering for sale, or sale of 

any fuel or fuel additive if tiie 

Administrator finds that the emission 

products of such fuel or fuel additive 

"causes, or contributes, to air pollution 

which may reasonably be anticipated to 

endanger the public health or welfare." 

Further, the Administrator must find 

that such prohibitions "Vill not cause 

the use of any other fuel or fuel additive 

which will produce emissions which will 

endanger the public health or welfare to 

the same or greater degree than the use 

ofthe fuel or fuel additive proposed to 

be prohibited." Therefore, the purpose of 

section 211 is not to require submission 

of data and information for its own 

sake, but to assist EPA in the regulation 

of fuels and fuel additives. 

EPA faces practical constraints in 

accomplishing its task. Currently, 2,200 

fuels and 4,300 fuel additives are 

registered for use. Emissions speciation 

and emissions toxicity testing are 

complex, requiring tiie operation of 

vehicles or engines in a laboratory and, 

in the case of toxicity testing, the 

inhalation exposure of animals to 

emissions under very controlled -

conditions. EPA knows of only a few 

commercial laboratories which currently 

offer the full range of emission 

generation and speciation procedures 

proposed in this rule, and is not aware 

of any commercial biological testing 

facilities which, at the present time, 

offer toxicity testing services involving 

the constant inhalation exposure of live 

animals to fuel and fuel additive 
emissions. Also, while screening 

batteries can be conducted in only a few 

weeks or months, more extensive testing 

may require long term exposures or the 

exposure of more than one generation of 

animals. 

Accordingly, the proposal attempts to 

address these practical constraints 

while providing EPA with sufficient 

information to exercise its authority 

under section 211(c). First, EPA proposes 

to recognize adequate existing data. By 

adequate, EPA would recognize studies 

conducted reasonably in accord with the 

guidelines specified in this rule. Second, 

EPA has proposed a voluntary grouping 

scheme by which manufacturers of fuels 

and fuel additives with similar chemical 

composition may test one substance as 

a representative of all substances within 

the group. (Because manufacturers may 

not wish to share data on the 

composition of tiieir products with 

others, the grouping scheme would be 

voluntary; however, each fuel or fuel 

additive would be required to be tested 

either separately or as part of a group.) 

EPA would use the information from the 

test substance to evaluate the risk of all 

substances within the group, unless 

adequate data on a particular member 

of the group becomes available. 

Manufacturers would benefit by sharing 

the cost of testing. Through this 

voluntary grouping system, EPA 

estimates tiiat among currently 

registered unleaded gasoline, leaded 

gasoline, and diesel products, about 115 

groups could be formed, which is a much 

more reasonable number of testing 

subjects given the practical constraints 

on testing. Test data obtained as a result 

of the proposed rule would thus give 

EPA a general picture of how different 

types of fuels and fuel additives 

compare to one another, which is 

consistent with section 211(b) in light of 

EPA's authority under section 211(c). 

Fuels and additives registered as 

relabeled products (i.e., simply 

repackaged versions of formulations 

which are also registered by the original 

manufacturers) would be specifically 

exempted from the new information 

gathering and testing requirements 

proposed in today's rulemaking. Because 

separate assessment of relabeled 

products would clearly duplicate the. 

efforts of the original manufacturer, EPA 

has chosen to exercise the authority in 

section 211(e)(3)(C), which allows EPA 

to exempt fuels and additives from the 

provisions of section 211(b)(2) under 

duplicative circumstances. However, if 

the original manufacturer should fail to 

fulfill the proposed registration 

requirements, then the relabeler would 

be at risk for losing his supply of the 

relabeled product. Furthermore, EPA 

expects that the original manufacturers 

wou$#pasa the costs of testing along to 

theii9 customers, including repackagers. 

IiMaBoither matter pursuant to section 

211{e)p|(C), IPA requests comment 

from the public in regard to the 

adequacy of existing information on 

"bas>Kne" conventional fuels and fuel 

additives, including baseline diesel, 

unleaded gasoline, and leaded gasoline 

formulations (as defined in Section IV, 

below}. A multitude of studies, 

conducted by many researchers over 

sever-aj decades, have addressed the 

emis^iens-based effects of these 

products on the public health and 

welfare and on emission control system 

performance. The published results and 

conclusions from these tests have 

provided the foundation for many 

legislative initiatives and regulatory 

actions, in the area of mobile-source air 

pollutien. EPA invites detailed comment 

on the extent to which the available 

information on these conventional fuels 

and additives is adequate for ongoing 

regulatory decision-making and, with 

respect to the testing requirements 

proposed ki this rulemaking, the extent 

to weigh significant gaps may still 

remain in the available data base. 

B. Emissions Focus 

While the requirements proposed in 

this NKRM are primarily concerned with 

information coUection, the underlying 

purpose of the rule is to guide the 

direction of related regulatory activities 

which might be undertaken in the future. 

The siaMe instructs EPA to promulgate 

requirements for "reasonable and 

necessary" information about the effects 

of fuels and additives and, as described 

above, provides mechanisms under 

section 211(c) for taking action based 

upon this information. Therefore, it 

would appear most reasonable in this 

instance for EPA to focus its information 

requirements to subject areas which 

serve the regulatory objectives of 

section 211(c). 

Accordingly, EPA interprets section 

211 to; give it authority to focus testing 

on the emissions effects of fuels and fuel 

additives. By emissions effects, EPA 

means both the effects from combustion 

and evaporation of fuels and fuel 

additives resulting from their use in 

motor vehicles. The purpose of obtaining 

data on fuels and fuel additives is to 

provide a basis for further risk 

characterization and possible regulation 

under section 211 (c]. CAA section 

211(c)(1) states: 

The Administrator may, from time to time 

on the basis of information obtained under 

subseetien (b) of this section or other 

information available to him, by regulation, 

control or prohibit the manufacture, 

introduction into commerce, offering for sale, 

or sale of any fuel or fuel additive for use in a 

motor vehicle * * * (A) if in the judgment of 

the Administrator any emissions product of 

such fuel or fuel additive causes or 

contributes to air pollution which may 

reasonably be anticipated to endanger the 

public health or welfare * * * or (B) if 

emission products * * * will impair * * * the 

performance of any emission control device 

or system in general use * * * 

Similarly, CAA section 211(c)(2)(C) 

states: 

No fuel or fuel additive may be prohibited 

by the Administrator under paragraph (1) 

unless he finds, and publishes such finding, 

that in his judgment such prohibition will not 

cause the use of any other fuel or fuel 

additive which will produce emissions which 

will endanger the public health or welfare to 

the same or greater degree than the use of the 

fuel or fuel additive proposed to be 

prohibited. 

Thus, the plain language of CAA section 

211(c) states that EPA is authorized to 

regulate fuels or fuel additives based on 

the impact of their emissions on health 

or welfare. This is consistent with the 

legislative history of the provision as 

well. The House and Senate Reports on 

the CAA Amendments of 1970 link the 

information to be obtained under CAA 

section 211(b) to EPA's authority to 

regulate under CAA section 211(c).1 The 

Senate explicitiy stated: 

In matters related to public health and 

welfare, the Committee's concern is with the 

effect of the actual emissions from the -

tailpipe, not with the composition of the fuel. 

The combustion of the fuel in its intended 

environment—inside an engine with emission 

control would be the proper criterion for the 

Secretary to use in judging the health and 

welfare effects of that fuel. (Leg. Hist, at 434) 

The legislative history of the 1977 

CAA Amendments also indicates that 

CAA section 211 is focused on 

emissions effects. For example, in 

characterizing section 211(b), the House 

report states that it allows testing "to 

determine the health effects of the 

emission products of fuels or fuel 

additives."

 a Thus, based on the plain 

language of the statute and its 

legislative history, EPA believes it is 

reasonable to interpret section 211 of the 

Clean Air Act to allow EPA to focus 

testing on the emissions effects of fuels 

and fuel additives. 

1

 H. Rep. No. 1140.91 Cong. 2d Sess. (1980) at 13. 

reprinted ln Environment and Natural Resources 

Division of the Library of Congress. 93d Cong., 2d 

Sess.; A Legislative History of the Clean Air Act 

Amendments of 1970 (Comm. Print 1974) ("Leg. 

Hist.") at 433-434. 

' N. Rep. No. 294.95th Cong.. 1st Sess. (1977) at 

25. reprinted in 1977 U.S. Code Cong.' A Ad. News 

1103, 
P.1.0 

Federal ifflr\/;Vol. 57, ^9.^ 73,/j TWpdfleaday, Apr# 15.- 1992 / Proposed t^pjestmfs" 

The proposed emissions focus will 

help to avoid overlap with regulatory 

initiatives which may be taken in 

conjunction with the Toxic Substances. 

Control Act (TSCA). the Resource 

Conservation and Recovery Act 

(RCRA), and the Occupational Safety 

and Health Act (OSHA); Under certain 

circumstances, the health and/or 

welfare effects associated with the 

production, handling, and use of fuels 

and additives may fall within the 

domain of these other regulatory 

programs. Restricting the general focus 

of today's proposed rulemaking to the 

effects of fuel and additive emissions 

will help to minimize the potential for 

programmatic overlap, r 

C. Applicability of Types of Emissions 

Both combustion emissions (exhaust) 

and evaporative emissions are major 

contributors to potentially harmful air 

pollution, and both are included within 

the general, focus of today's proposed 

rule. Concerns about the public health 

impacts of emissions from both of these 

sources are documented in the 

legislative proceedings associated with 

the enactment of section 211. Since that 

time, however, a number of existing and 

planned regulatory initiatives and 

industry innovations have decreased the 

potential risk of exposure to fuel and 

additive evaporative emissions, 

including the vapors which arise from 

fueled vehicles and those which are 

released during refueling operations. 

Thus. EPA invites comments in regard to 

the continuing need for assessing the 

health and environmental effects of 

evaporative emissions. 

Exhaust emissions are inevitable 

products of the engine combustion 

process, and requirements to assess the 

potential adverse effects of engine 

exhaust are generally applicable to all 

motor vehicle fuels and fiiel additives. 

This is not always true for evaporative 

emissions. In the case of fuels which are 

supplied to motor vehicle engines by 

way of sealed containment and delivery 

systems (e.g., liquified petroleum gas 

and compressed natural gas), the need 

for evaporative emission testing is less 

important, since human and ecosystem 

exposures will be extremely low or 

nonexistent. For ordinary liquid fuels 

and additives, the significance of 

vaporization varies widely, depending 

on the inherent volatility of the fuel or 

additive. 

In this regard, a readily available 

volatility measurement which correlates 

with fuel tank evaporative losses is the 

Reid Vapor Pressure (RVP). Based on 

empirical analysis, EPA proposes that 

an RVP of 2.0 pounds per square inch 

(psi) be designated as the threshold for 

determining the applicability of 

evaporative emission testing 

requirements for fuels. That is, fuels 

with RVP of 2.0 psi or greater would be . 

subject to information and testing 

requirements established for 

evaporative emissions, while those with 

RVP less than 2.0 psi would be excused. 

Among motor vehicle fuels available in 

today's marketplace, only diesel fuel, 

with its extremely low volatility 

reflected in an RVP of approximatley 0.1 

psi, falls below the proposed threshold. 

Gasoline, alcohol fuels, and gasoline/ 

oxygenate blends have RVPs well above 

the 2.0 psi cutoff point, and would thus 

be subject to any requirements which 

might be established for evaporative 

emission testing. Arguments pan be 

made that other RVP cutoff points.in the. 

range of 2.0-5.0 psi might also be 

appropriate, and EPA requests 

comments on the best alternative. 

With respect to additives. EPA 

proposes to require evaporative 

emission testing when the applicable 

additive/base fuel mixture meets either 

of two criteria. First, evaporative 

emission testing would be required if the 

RVP of the additive/base fuel mixture is 

increased by 0.1 psi or more in 

comparison with the RVP of the base 

fuel alone. Second, evaporative emission 

testing would be required if the partial 

pressure of the additive in the vapor 

phase, at 100 degrees Fahrenheit and 

atmospheric pressure, is 0.1 psi or 

greater. The partial pressure of the 

vaporized products of the additive/fuel 

mixture in ambient air could be 

determined through testing or by using 

thermodynamic models that account for 

the vapor pressures and interactions of 

the substances involved. While the 

specified criteria reflect a conservative 

approach, they would riot require testing 

when an additive has a negligible 

volatility effect. '•'!' . 

EPA asks for comment in regard to the 

suitability of using Reid Vapor Pressure 

and partial pressure measurements to 

. determine the applicability of 

evaporative emission testing 

requirements for fuels and additives. 

Comments are also invited regarding the 

proposed threshold RVP and partial 

pressure values. 

In addition to requirements for testing 

the effects of combustion and 

evaporative emissions, EPA has 

considered incorporating the 

atmospheric transformation products of 

such emissions within the proposed 

testing program. Transformation 

products arise in the atmosphere from a 

series of extremely complex chemical 

reactions involving atmospheric gases 

. and volatile emissions, usually in the 

presence of ultraviolet sunlight. One of 

the results of the transformation process 

is known as photochemical smog; Its 

characteristics include reduced 

visibility, high levels of oxidants such as 

ozone, formaldehyde, acrolein, 

peroxyacetyl nitrates, and otiier 

oxygenated and nitrated organic 

substances. These secondary air 

pollutants from motor vehicle emissions 

are prevalent in the air of all urban 

areas in the United States, posing 

threats to public health, vegetation, and 

materials which may surpass those 

associated with the parent compounds 

themselves. By causing crop losses and 

accelerating the deterioration of natural 

and man-made materials such as rubber, 

paint, building stone, and fabric, urban 

smog also causes substantial economic 

losses. Thus, atmospheric 

transformation products are a major 

factor to be considered in characterizing 

the overall risks associated with fuel 

and additive emissions, and a great deal 

of study on their formation and effects is 

needed. 

At the present time, however, rather 

than requiring laboratory testing of 

transformation products, EPA is 

proposing a theoretical approach to the 

issue. The conduct of valid sampling and 

testing procedures on the primary 

emissions of fuels and additives requires 

many technical problems, to be 

overcome and many sources of 

variability to be addressed. These 

complexities are compounded further 

when attempting to create secondary 

transformation products of the . 

emissions under controlled conditions 

and trying to carry out a meaningful 

testing program on the resulting 

chemical mixture. •' 

While the scientific community has 

begun to develop experimental methods 

for modeling emission transformation 

processes in the laboratory^ experience 

in this area is relatively limited and the 

necessary facilities are available in only 

a very few academic settings.. 

Furthermore, the current knowledge 

base in this field of investigation does 

not permit the unequivocal identification 

of cause and effect relationships 

between discrete fuel or additive' 

formulations and specific products of 

photochemical transformation. Thus, 

even if a broad-based testing program 

could be implemented, the results would 

probably not be useful in discriminating 

the specific contributions of different 

fuels and additives to the formation and 

effects of transformation products. 

These scientific, technical, and 

practical considerations have persuaded 

EPA to exclude laboratory testing 

requirements for atmospheric 
P.11 

13176 Federal Register / Vol. S7,1 No. 73 / Wednesday; Apriri5, 19^2 /Appose d Rules 

transformation products from today's 

proposed rule. However, these 

considerations do not preclude 

theoretical approaches for providing 

information about the photochemical 

reactivity of the emission products of 

fuels and fuel additives. Possible 

approaches include the use of 

mechanistic kinetic models, which can 

in many instances predict the 

degradation products arising from 

atmospheric photochemical reactions, or 

theoretical projections by qualified 

atmospheric chemists. Such 

requirements are included in the 

proposed program and are discussed 

further in Section VLB of this NPRM. 

Furthermore, requirements for direct 

laboratory testing of atmospheric 

transformation processes may be added 

in future amendments to the rule if 

advances in the field make this feasible. 

D. Scope of Emission Control System 

Testing 

As previously discussed (see section 

II.D.2), EPA proposes to satisfy the 

provisions in section 211(b)(2) regarding 

emission control system testing by 

reference to the existing fuel and 

additive waiver application program 

implemented under section 211(f). Under 

the existing program, fuel and additive 

formulations which are not 

"substantially similar" to designated " 

certification fuels (as defined in 58 FR 

5352, February 19,1991) cannot be 

introduced into commerce unless a 

waiver is issued by EPA. To obtain such 

a waiver, the producer of the fuel or 

additive must show that the "dissimilar" 

product does not adversely affect the 

ability of a motor vehicle's emission 

control system to achieve compliance 

with certification standards during the 

useful life of the vehicle. 

A waiver request must address the 

impact of the product on tailpipe 

emissions, evaporative emissions, 

materials compatibility, and 

driveability. This has typically involved 

emission testing in accordance with the 

Federal Test Procedure (FTP) (40 CFR 

part 86) and, in certain cases, 

substantial durability testing to assess 

potential long-term effects. 

Rigorous protocols are necessary to . 

ensure fully that emission control 

performance will not be compromised, 

and are warranted for fuels or fuel 

additives which depart from 

conventional formulations. As routine 

requirements for the registration of fuels 

and additives, however, such rigorous 

and costly protocols may not be 

reasonable. The section 211(f) waiver 

program functions on an exception 

basis, an approach which has proven 

both practical and effective as applied 

to unleaded gasoline fuels and 

additives. Revisions currently under 

development will extend the 

applicability of the waiver program to 

other fuel and additive categories for 

which emission certification standards 

are established. These changes will 

enhance the capacity of the waiver 

program tc adequately fulfill the aims of 

the emission control testing provisions 

of section 211(b). 

Therefore, the emission control 

system testing provisions in today's 

proposed rulemaking are fully integrated 

with the existing section 211(f) program. 

With respect to new fuels and additives, 

manufacturers' responsibilities in this 

area would be unchanged. Products 

which conform to applicable "sub sim" 

definitions would not be required to 

undergo emission control system testing 

before they can be registered. On the 

other hand, new fuels and additives 

which do not meet "sub sim" criteria 

would be subject to the regular section 

211(f) waiver application process prior 

to registration. 

The only proposed new application of 

EPA's authority under section 211(b) to 

require emission control testing pertains 

to fuels and additives which were 

registered in the past even though they 

were not "sub sim" and did not undergo 

waiver application procedures. As 

discussed previously in section II.D.2. of 

this NPRM, such registrations have 

occurred because fuel and additive 

products other than unleaded gasoline 

and related bulk additives did not 

become subject to section 211(f) 

prohibitions until the enactment of the 

CAA Amendments on November 15, 

1990. As a result, some "non-sub-sim" 

products introduced prior to that date 

were allowed to be registered without 

first undergoing the emission control 

system testing which the waiver 

application process ordinarily entails. 

Nevertheless, in the absence of evidence 

linking "grandfathered" products to 

emission control system problems, EPA 

believes it may not be reasonable or 

necessary to force all such products to 

undergo emission control system testing 

years after their initial registration and 

commercial distribution. 

Such evidence of adverse emission 

control effects may come to light as a 

result cf emission characterization 

requirements included within the health 

effects testing provisions of today's 

proposed rulemaking. The proposed 

emission characterization requirements 

include Federal testing procedures to 

determine the levels of regulated 

emissions generated by the fuel/ 

additive of interest. Should any of the 

regulated emission products exceed 

established certification standards, a 

need for examination of the product's 

effects on emission control may be 

indicated. 

EPA also proposes to set up a 

mechanism which would permit vehicle 

manufacturers or other outside parties 

to submit petitions to EPA, citing 

evidence that certain brands, 

formulations, or specific components of 

fuels or additives are harmful to 

vehicular emission control. If EPA 

judges that emission control system 

testing is warranted after reviewing the 

petition arguments, emission 

characterization results, and/or other 

available information, the authority 

provided by section 211(b) will be 

exercised to bring specified fuels and 

additives into the waiver application 

program when they would otherwise be 

excused by the "grandfathering" 

provisions of section 211(f). 

EPA requests comments on the 

adequacy of this proposed approach. As 

an alternative, the authority of section 

211(b) could be exercised to require all 

"grandfathered" products to undergo 

waiver request procedures under section 

211(f) if they do not conform to 

applicable "sub sim" criteria. Comments 

are solicited in regard to the specific 

necessity and the likely costs and 

benefits of this more comprehensive 

approach in comparison to the 

mechanism described above. 

E. Scope of Health Effects Evaluation 

1. Background ~ 

Registration requirements concerning 

the health effects of fuels and fuel 

additives could potentially encompass a 

vast range of endpoints, exposure 

scenarios, mechanisms of action, and 

experimental protocols. Taking into 

account the number of fuels and 

additives in question, a comprehensive 

toxicologic program could easily 

overwhelm the capacity of existing 

laboratory facilities and support 

systems, and the total costs of such a 

program would be very likely to exceed 

its expected benefits. Over 6,000 fuels 

and additives are currently registered, 

and this population is expected to 

undergo further growth in the near 

future as reformulated and alternative 

fuels and their additives gain a wider 

role in the marketplace. 

Other than stipulating three endpoints 

which must, at a minimum, be included 

in the regulations, section 211(b) gives 

EPA discretion to apply its expertise in 

determining the scope of the health 

effects evaluation program. In exercising 

this discretionary authority, EPA has 

recognized that some areas of inquiry 
P.12 

Federal Register. /Vol. 57, No. 73;/ < Wednesday, April 15, 1992 / Prdpdsed iRules 15177 

which are of legitimate scientific interest 

may not be reasonable or necessary to 

include in the context of a regulatory 

program. Rather than mandating 

comprehensive health effects testing as 

a routine registration requirement for 

every fuel and fuel additive, the program 

is designed tp address testing needs on 

a tiered basis, with allowance for more 

rigorous, resource-intensive 

requirements as indicated by existing 

data and lower tier screening tests. 

As previously discussed, EPA's plan 

to focus the rulemaking on the primary 

emissions of fuels and additives 

represents a major reduction in the 

potential scope of the health effects 

evaluation program. Consistent with this 

focus, the proposed health testing 

requirements are concerned with the 

effects of inhalation exposure to the 

evaporation and combustion products of 

fuels and additives. They do not 

specifically address the possible 

adverse effects of exposure to fuels and 

additives in the liquid state, nor do rhey 

include studies of atmospheric 

transformation products except at the 

level df data analysis and modeling. 

Significant reductions in program costs 

and overall impact on the fuel and 

additive industry are also expected as a 

result of proposed grouping mechanisms 

and provisions for exempting relabeled 

products from program requirements 

2. Health Effects Endpoints 

According to section 211(b)(2)(A), the 

endpoints to be addressed by the 

program must include, but need not be 

limited to, "carcinogenicity, 

mutagenicity, and teratogenicity". 

Carcinogencity refers to the potential of 

a substance to initiate or contribute to 

the transformation of normal cells into 

neoplastic cells and the further 

development of neoplastic cells into 

tumors. Mutagenicity is the ability of an 

agent to produce mutations, i.e., changes 

in the genetic information stored in the 

DNA of living cells. When such genetic 

changes occur in germinal tissue, they 

may represent heritable events. 

Teratogenicity, in the strictest sense, 

refers to the potential of a substance to 

cause adverse effects to a fetus in-utero, 

resulting in fetal mortality or birth 

defects. In today's proposed rule, EPA 

has chosen to expand this category to 

encompass general reproductive 

toxicity, including adult fertility effects. 

In addition to these mandatory areas 

of inquiry/many other health effect 

endpoints are germane to the 

assessment of the public health impacts 

of fuel and additive emissions. As 

discussed further below, the proposed 

program incorporates a literature search 

which covers all such endpoints and, on 

a case-by-case basis, also provides for 

possible testing to follow up on any 

significant concerns highlighted by the 

available literature. However, testing 

will routinely be required for only two 

health effect endpoints in addition to the 

mandatory endpoints described above. 

First, consistent with the program's 

focus on inhalation exposure, testing of 

publmonary toxicity is proposed. 

Second, in view of particular scientific 

concerns about the potential effects of 

fuel and additive emissions on the 

nervous system, testing for neurotoxicity 

is included. Neurotoxicity also serves as 

a good general indicator of potentially 

harmful chemical activity. 

3. Health Effects Evaluation Tiers 

As depicted in Figure 1, the proposed 

requirements for evaluating the health 

effects of fuels and additives are 

organized within a three-tier structure, 

with more rigorous requirements 

contained in each successive tier. In 

part, each tier is intended to function as 

a screen for determining the need for 

and applicability of requirements in 

subsequent tiers. The tiered approach 

also permits fuel and additive producers 

to make full use of test results and other 

information which may already be 

available about their products. This is 

consistent with the objectives of section 

211(e)(3), which authorizes EPA to take 

existing information into account to 

avoid duplicative testing requirements. 

BILLING COOE 6560-50-* 
13178 

P.13 

Federal Register / Vol. 57, Np. 73 / Wednesday, April 15, 1992 / Proposed Rules 

Figure 1: Overview of Evaluation Tiers 

START 

o Characterization of emissions 

o Summary of previous health 

and environmental studies 

o Analyses of atmospheric reactivity, 

exposure potential*, and environmental 

partitioning 

Inadequate 

existing 

information 

Tier 2 

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 

Tier 3 

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 I 

BILLING CODE 6560-50-C 
P.14, 

Federal! Kegister / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13179 

In brief, the proposed relationship 

between the three evaluation tiers 

would function as follows. Each 

manufacturer of a fuel or additive would 

be responsible for satisfying the 

requirements of Tiers 1 and 2. The 

results of both of these tiers would be 

reported to EPA simultaneously, 

according to the report format described 

in section VII of this NPRM. To the 

extent that previously conducted studies 

were available for the fuel or additive 

which satisfied the specified guidelines 

for the chemical and/or biological tests 

required in Tiers 1 and 2, the 

manufacturer could submit such existing 

studies in lieu of performing new 

duplicative tests. The requirements of 

Tiers 1 and 2 could be satisfied by 

manufacturers either on an individual 

basis or by way of a group submission 

consistent with the provisions of the 

grouping system discussed in section IV. 

Within eighteen months after receipt 

of a report for Tiers 1 and 2, EPA would 

determine whether the submitted 

information and testing were, in fact, in 

compliance with the specified 

guidelines. Manufacturers of existing 

products who failed to submit data or 

submitted data from tests that did not 

comply with the specified guidelines 

would be in violation of this rule and 

would be subject to the penalties 

specified in CAA section 211(d). Such 

persons would also have to submit the 

data originally required. Furthermore, if 

EPA determined that the data 

requirements of the rule were not met, 

EPA could revoke the registration of the 

subject fuel or additive. Manufacturers 

of fuels and additives not previously 

registered would be prohibited from 

registering and selling such products 

until EPA determined that the 

requirements of Tiers 1 and 2 were met 

satisfactorily. 

On the basis of the submitted Tier 1 

and Tier 2 data and any other available 

information, EPA would also determine, 

within five years of its receipt of a given 

Tier 1 and 2 submittal, whether further 

testing of the subject fuel or additive 

were required under the provisions of 

Tier 3. As discussed further below, this 

determination would depend on the 

extent to which Tiers 1 and 2 provide 

sufficient toxicity and exposure 

information to permit regulatory 

decisions to be made based on the 

severity and extent of adverse health 

risks. If Tier 3 testing were deemed 

necessary, EPA would notify the 

responsible manufacturer (or group) by. 

certified letter of the specific Tier 3 

requirement(s) along with a schedule for 

compliance and a deadline for submittal 

of the final report to EPA. EPA would 

provide the responsible manufacturer 

(or group) a 30-<lay comment period on 

the Tier 3 requirements, compliance 

schedule, and submission deadline. EPA 

would extend the comment period if it 

appeared from the nature of the issues 

raised that further time for comment 

were warranted. In the event that EPA 

received no comment within the given 

period, the manufacturer would be 

considered to have consented in full to 

the requirements. 

To keep the general public informed 

about the status of the testing program 

and to provide an opportunity for public 

input to the Tier 3 decision process, EPA 

intends to implement additional 

notification procedures. Beginning three 

years after promulgation of the final 

rule, and updated at least every two 

years thereafter while program activity 

remains high, EPA proposes to publish a 

notice in the Federal Register containing 

the following three lists: (1) Products (or 

groups) for which EPA has prescribed 

Tier 3 testing, (2) products (or groups) 

for which EPA intends not to prescribe 

Tier 3 tests based on current 

information, and (3) products (or groups) 

for which an adequate Tier 1 and 2 

submittal has been received by EPA but 

for which a decision on the necessity of 

Tier 3 testing is still pending. A product 

would not be included in the notice until 

EPA has received the respective Tier 1 

and 2 submittal and has reviewed it for 

adequate compliance with Tier 1 and 2 

requirements. 

For six months following each Federal 

Register notice, EPA would accept 

petitions from the public requesting that 

particular products be required to 

undergo Tier 3 testing when EPA has 

indicated that such testing would not be 

prescribed or when the Tier 3 decision is 

still pending. To be considered by EPA 

such petitions would be expected to 

include substantive reasons for the 

specific testing requested. The petitions 

would not be binding on EPA; however, 

each such petition and EPA's formal 

response would be placed in the docket 

for public inspection. 

The following sections discuss the 

general scope of the requirements in 

each health effects evaluation tier and 

the criteria to be used in making the 

compliance determinations mentioned 

above. More detailed discussion of the 

individual tier requirements is provided 

in sections V-VII of this NPRM. 

Tier 1. The scope of Tier 1 

encompasses chemical analysis, 

literature search, and modeling or 

analytic methods. These components of 

the evaluation are designed to provide 

basic data on fuel and additive emission 

products and to permit a review and 

assessment of the adequacy of existing 

information on related health effects. 

Proposed requirements for the 

chemical analysis of fuel and additive 

emissions would satisfy the provision in 

section 211(b)(2) "to determine the 

emissions resulting from the use of the 

fuel or additive contained in such fuel", 

and would also provide a useful 

inventory of potentially harmful fuel and 

additive emission products. To this end, 

manufacturers would be responsible for 

the generation, collection, and sampling 

of the combustion emissions of their 

fuels and additives, and for the conduct 

of tests to determine the identity and 

concentration of individual emission 

products. The analyses would include 

(1) EPA procedures for the measurement 

of regulated emissions, (2) 

chromatographic procedures for the 

speciation of volatile hydrocarbon 

compounds, aldehydes, ketones, 

alcohols, ethers, and polycyclic aromatic 

hydrocarbons (PAHs and NPAHs), and 

(3) special procedures for the 

determination of the chemical fate of 

metals, halogens, and other elements of 

special concern when such elements are 

known to be present in the raw fuel or 

additive formulation. When applicable, 

evaporative emissions would also need 

to be generated, collected, and 

characterized. In the case of additives, 

the emissions from the respective 

additive/base fuel mixture would need 

to be compared with the emissions from 

the base fiiel alone, in order to 

distinguish the additive's contribution to 

the emission products. 

The second proposed Tier 1 

requirement is a comprehensive survey 

of the relevant, scientific literature. Both 

public and in-house (e.g., manufacturer 

or industry) sources would be included 

in the survey, providing a compilation of 

all available information from previous 

emission characterization and health 

effects testing done on the whole 

emissions and emission products of the 

fuel or additive in question or on the 

emissions of similar fuels and additives. 

For this purpose, "similar" fuels and 

additives would be those which meet 

the criteria for enrollment in the same 

fuel/additive group as the subject fuel or 

additive, pursuant to the grouping 

system proposed in section IV of this 

notice. 

One of the functions of the literature 

search would be to determine the 

availability of adequate existing testing 

which could be submitted by 

manufacturers in compliance with the 

requirements of the registration 

program. If the results of the required 

emission characterization procedures 

mentioned above were already 

I l l IIMM 
I I 'I'Hf'P 

P.15 

13180 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 /Propose d Rules 

available in the existing literature, then 

those procedures would not need to be 

repeated. Similarly, manufacturers could 

use the outcome of the literature search 

to determine the applicability of Tier 2 

biological testing requirements. To the 

extent that the literature contained 

adequately conducted previous studies 

that conformed to the guidelines 

specified for any tests included in Tier 2, 

then such Tier 2 tests would not need to 

be done. 

In determining whether such previous 

studies were adequate substitutes for 

conducting the Tier 2 tests, the 

manufacturer would need to consider a 

number of factors. First, the previous 

testing in regard to any given endpoint 

would have to address tiie effects of 

inhalation exposure to the whole 

combustion or evaporative emissions of 

the respective fuel or additive. Tests 

performed on the emissions of fuels and 

additives which could be classified in 

the same group as the subject fuel or 

additive would be considered relevant, 

but tests on products not conforming to 

the relevant group definition would not 

apply. Raw product testing, using fuels 

or additives in the liquid state or as 

whole aerosolized preparations, would 

not suffice. In general, inhalation studies 

on the individual emission products of 

the fiiel or additive would not 

adequately substitute for whole 

emissions, unless emission 

characterization studies showed that an 

additive has only one emission product 

that differentiates its emissions from the 

base fuel. Documentation would need to 

be sufficient to determine that the 

studies were conducted in a manner 

consistent with generally accepted 

scientific principles, good laboratory 

practices, and the specific testing 

guideline in question. Important 

parameters would include the type and 

number of test subjects, the number and 

adequacy of dosages, the methodology 

and duration of inhalation exposure, 

and the technical methods used for 

momtoring the progress of the test and 

for analyzing the results. In general, the 

exposure duration would need to be at 

least as long as that stipulated in the 

specified Tier 2 guideline; however, 

shorter exposures would be acceptable 

if the test results were positive, 

including a demonstrable dose-response 

relationship. Finally, the age of the data 

would be a consideration. In view of 

technological advances and changing 

technical standards, older studies would 

be less likely to be acceptable than more 

recent studies. Nevertheless, the quality 

of the study would be the deciding 

factor, not the age per se. These same 

considerations would later be used by 

EPA in judging whether the submitted 

tests were in compliance with the 

program requirements. 

The third proposed Tier 1 requirement 

would involve data analysis and 

modeling approaches. Appropriate 

methods would need to be selected and 

used for projecting ambient 

concentrations of the various emission 

products and for evaluating the chemical 

reactivity and fate of the emitted 

compounds in the atmosphere. 

Tier 2. The second evaluation tier is 

composed of a series of short-term 

laboratory tests which comprise a 

iriifliHHHB screening battery for the 

previously designated health endpoints. 

Most of the proposed tests involve 

exposure of laboratory animals to the 

whole emissions of fuels or additive/ 

fuel mixtures. One exception is the 

Ames reverse mutation assay, which is 

comprised of a series of in-vitro studies 

utilizing bacterial substrates. 

Because mutation is one of the major 

mechanisms involved in the 

transformation of normal cells to 

neoplastic cells, there is some overlap in 

the screening tests required for 

determining the potential 

carcinogenicity and mutagenicity of fuel 

and fuel additive emissions. Proposed 

Tier 2 requirements related to one or 

bofh of these two endpoints include (1) 

the Ames reverse mutation assay, (2) in 

vivo micronucleus assay, and (3) in vivo 

sisiter chromatid exchange assay. As 

mentioned above, the Ames assay 

invokes in-vitro procedures. The other 

tests in this series require inhalation 

exposures of test animals to the 

emissions of the fuel or fuel/additive 

mixture, followed by harvesting, culture, 

and analysis of designated cell types. 

Ihe proposed screening tests for the 

other specified endpoints would 

geneBafty involve the controlled 

exgrosuse ef test animals by inhalation 

to feel or additive emissions at three 

different dilutions for six weeks. 

Following the period of exposure, 

relevant structures would be examined 

for morphologic, histologic and 

. functional changes related to the given 

enctpeiat. Developmental (teratogenic) 

effects would be studied by exposing 

pregnant females to emissions during 

the Brest sensitive period of pregnancy, 

followed by examination of the uterus 

and its contents just prior to the normal 

time of parturition. Testing for adult 

reproductive effects would require the 

exposure of rodents before and after 

mating a<nd throughout pregnancy, with 

sub^efuent evaluation of the offspring 

as well as analysis of the reproductive 

organs and tissues of the adult animals. 

Together with the information from 

Tier 1 on the composition of emissions 

and on the estimated chemical reactivity 

and potential risk of exposure to these 

substances, the proposed Tier 2 tests 

will provide a substantial body of data 

on the potential public health and 

welfare effects of the emissions 

produced by a fuel, additive, or group of 

formulations. If significant adverse 

effects appear very unlikely, the 

evaluation process would be complete 

at the end of Tier 2. However, if the 

associated risks are still uncertain, 

additional testing might be required 

under Tier 3. 

Tier 3. After the results of the first two 

tiers have been submitted and reviewed, 

EPA will detennine whether sufficient 

data are available on the health effects 

and exposure characteristics of the fuel/ 

additive emissions to pennit potential 

regulatory decisions to be made. If the 

information is adequate to allow EPA 

reasonably to conclude that the fuel or 

additive is quite likely to have either 

very low health risks or unacceptably 

high health risks, additional testing 

would probably not be required. 

However, if the health risk potential is 

still uncertain, additional studies might 

be required at the Tier 3 level to resolve 

the uncertainties. The specific Tier 3 

tests required would be determined on a 

case-by-case basis at EPA's discretion. 

While EPA will not ordinarily perform 

a formal risk characterization when 

determining whether to exercise the Tier 

3 authority, both health effects data and 

exposure information will be 

considered. For example, if the potential 

health effects of exposure were very 

severe, then a need for Tier 3 would be 

suggested even if the exposed 

population were relatively small. If the 

potential adverse effects were more 

moderate or equivocal, a larger 

population would generally need to be 

at risk before Tier 3 testing would be 

required. Additional testing might also 

be required when the results of Tier 2 

tests are negative (i.e., apparently nontoxic), if EPA judged that inadequate 

laboratory procedures or techniques 

interfered with the test results. 

While the specific objectives and 

scope of Tier 3 testing would vary 

depending on the concerns identified in 

the earlier tiers, chronic (2-3 year) 

inhalation studies would sometimes be 

included. Chemical disposition studies, 

exposure studies, and dosimetry 

analyses as well as additional emission 

characterization requirements might 

also be imposed. These requirements 

would most often be intended as followup to studies included in Tier 2. 

However, EPA reserves the general 
P.16 

Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13181 

authority to require the evaluation of 

other endpoints if available information 

indicates that this is necessary for 

regulatory decision-making. For 

example, if the literature search suggests 

that the emissions of a fuel or additive 

are toxic to the liver or kidneys, then 

EPA would not be precluded from 

imposing hepatotoxicity or renotoxicity 

testing requirements under Tier 3 simply 

because screening studies for these 

endpoints were not included under Tier 

2. 

Section VI of this NPRM presents 

further discussion on the circumstances 

which would lead EPA to conclude that 

Tiers 1 and 2 provide sufficient 

information without invoking Tier 3, the 

potential criteria for imposing Tier 3 

testing requirements, and the likely 

nature of such requirements. 

4. Timing Considerations 

The organization of the program's 

health effects evaluation requirements 

into hierarchical tiers ensures that the 

proposed rule accommodates the goals 

of both section 211(e) and section 211(b). 

Section 211(e) requires that, for existing 

fuels and fuel additives, the "requisite 

information" be furnished to EPA within 

three years of the implementation of the 

final rule. For fuels and additives not yet 

registered when the final rule is 

promulgated, submission of the required 

information will be a prerequisite for 

registration. However, section 211(e) 

also requires EPA to implement the 

authority under section 211(b), which 

gives the Administrator discretion to 

require testing to determine the potential 

public health or welfare effects and to 

"receive changes in the information 

required." Thus, while section 211(e) 

contains a time frame of three years for 

submission of data, it also mandates 

that EPA implement its broad 

discretionary authority to require the 

testing it considers necessary to assess 

the public health and welfare effects of 

fuels and fuel additives. 

In 1977, Congress believed that short 

term testing methods would often be 

adequate to determine long term health 

effects. (See H. Rep. No. 95-294, at 309, 

Legis. Hist, at 2776, "However, the 

paramount interest in protection of 

public health requires that test protocols 

be reasonably comprehensive * * ° . 

Relatively inexpensive but reliable test 

methods are increasingly becoming 

available for these purposes and these 

test methods should be utilized insofar 

as possible.") The proposed short term 

tests included in Tier 2 reflect this 

approach and, indeed, may often 

eliminate the need for further evaluation 

of a fuel's or additive's effects on certain 

endpoints. 

However, these "relatively 

inexpensive" methods have generally 

not advanced to the point where they 

can always serve as acceptable 

substitutes for traditional studies 

entailing long term in vivo exposures. In 

some instances, the short term tests may 

reveal potential hazards without 

providing sufficient information to 

determine the longer term consequences 

of the observed effects or the extent to 

which they represent significant public 

health or welfare risks. To obtain more 

definitive information, tests of longer 

duration may sometimes be needed. For 

example, a higher order reproductive/ 

developmental study would take close 

to a year, chronic toxicity tests might 

require one to two years, and 

carcinogenesis might not be observable 

until the late stages of a two- to threeyear experimental exposure. The 

additional time required for test vehicle 

mileage accumulation. Tier 1 and 2 

assessments, protocol development, 

study set-up, and results evaluation 

would effectively preclude submission 

within the prescribed three years. 

Therefore, EPA has accommodated 

the time frame set forth in section 211(e) 

with the objectives of section 211(b) by 

using a tiered approach to testing. Data 

prescribed under Tiers 1 and 2 would be 

required to be submitted within three 

years of the effective date of the rule for 

existing products, and prior to receiving 

registration for new products. On the 

basis of such information, EPA would 

determine if further testing were needed 

under Tier 3 to assess the attendant 

risks. If Tier 3 testing were required, for 

either new or existing products (or 

groups), registration would be granted, 

but would be conditioned upon 

satisfactory compliance with the Tier 3 

data requirements according to a 

timetable determined by EPA to be 

appropriate to these requirements. If 

additional testing were needed only to 

make up for deficiencies in information 

content or testing technique related to 

Tiers 1 and 2, then the original threeyear time frame would still be in force. 

Notwithstanding the granting of a 

registration, if EPA determined that a 

fuel or additive was likely to present a 

substantial risk to the public health or 

welfare, then EPA could invoke 

available regulatory authority under 

other Federal law, including CAA 

section 211(c) or applicable sections of 

TSCA. 

F. Scope of Welfare Effects Evaluation 

Section 211(b)(2)(B) states that the 

Administrator may require 

manufacturers to furnish "reasonable 

and necessary" information for 

determining "the extent to which (fuel 

and fuel additive] emissions affect the 

public health or welfare". The term 

"welfare effects" refers generally to the 

impact which air pollution produced by 

motor vehicle fuels and fuel additives 

may have on the environment, and 

encompasses a broad range of effects on 

aquatic and terrestrial ecosystems, 

cultivated crops and other vegetation, 

natural and man-made materials, 

wildlife, and stratospheric ozone. Air 

pollution effects on the public welfare 

also include important environmental 

concerns such as noxious orders or 

visibility impairment, which may detract 

from human well-being while not 

representing specific dangers to human 

health. 

A full assessment of the welfare 

effects of mobile-source air pollution 

would need to take into consideration a 

large number of complex and 

interrelated factors: the residence time 

. of fuel and additive emissions in the air, 

the chemical reactions of the emissions 

with other air pollutants, the dispersion 

and deposition of the emissions and 

their atmospheric by products, the 

ability of animals and plants to 

bioconcentrate these substances, and 

the specific consequences to various 

ecosystems and to the public's wellbeing. Such avenues of investigation are 

extremely important to our general 

understanding of the causation and 

effects of air pollution. Future scientific 

study in these areas will be critical in 

guiding the development of general 

policies and effective regulatory 

approaches for reducing the 

environmental risks of air pollution. 

However, at the present time, EPA 

proposes not to include laboratory 

testing for welfare effects in the 

requirements of the fuel and additive 

registration program. Except for 

stipulating that welfare effects 

requirements should be "reasonable and 

necessary", section 211(b) gives EPA the 

discretion to determine the scope of the 

assessment In contrast to the provisions 

regarding health effects, the statue does 

not specifically require testing to be 

done to evaluate the effects of fuels and 

additives on the public welfare, and 

does not mandate specific endpoints for 

welfare effects assessment. At the 

present time, scientific experience and 

laboratory screening methods in this 

complex area are more limited than in 

the area of health effects. Furthermore, 

other EPA programs are actively 

involved in researching and controlling 

mobile and stationary source 

contributions to major air pollution 

problems such as tropospheric/ 

stratospheric ozone, global warming, 

and acid rain. 
P.17 

13182 - Federal Register / Vol. 57, No. 73 / Wednesday , April 15, 1992 / Proposed Rules 

For these reasons, EPA plans to 

address the area of welfare effects using 

approaches other than biological testing. 

Under this proposal, welfare effects 

requirements would include emission 

characterization, literature research, and 

modeling/analytic methods. As 

previously discussed, Tier 1 requires 

responsible producers to conduct 

chemical speciation procedures to 

identify the emission products generated 

by fuels and additives. These 

procedures will yield an inventory of 

potential harmful air pollutants which 

may have significant impacts on the 

general environment and public welfare 

as well as on the public health. 

Secondly, Tier 1 includes a thorough 

literature search for existing healthrelated information about the emissions 

of fuels and additives. This requirement 

will be widened to encompass available 

scientific literature on welfare effects, 

including, but not necessarily limited to, 

the exposure and response of plants and 

animals to emissions, the potential for 

bioaccumulation, and the concentration 

and persistence of the emission products 

in the air, soil, and water. A search of 

databases on environmental toxicity 

(aquatic and terrestrial) will be included 

in this requirement. Finally, the 

modeling requirements of Tier 1 will 

include analysis of the environmental 

partitioning and fate of fuel and additive 

emission products and the potential for 

aquatic and terrestrial ecosystem 

exposure. As a result of these expanded 

Tier 1 activites, EPA would expect to 

obtain useful summaries and analyses of 

existing data on the welfare effects of 

fuel and additive emissions. 

While, at this time. EPA is not 

proposing to require biological testing 

for welfare effects, comments are 

requested on the need for and feasibility 

of including such tests in the program 

requirements. To be most useful, such 

comments should include specific issues 

to be addressed in possible welfare 

effects testing and practical 

apporoaches for examining these issues 

within the context of the registration 

program. One alternative is to retain the 

option of imposing welfare effects 

testing requirements at the Tier 3 level 

when the outcome of Tier 1 

demonstrates both significant 

environmental toxicity and exposure 

potential. The criteria for such decisions 

would be similar to those used for 

making health-related Tier 3 decisions. 

Thus, Tier 3 testing for welfare effects 

might be required if the environmental 

partitioning and exposure analysis 

reveals the potential for broad exposure 

at concentrations that are likely to pose 

a threat to sensitive plants and animals. 

If this alternative were adopted, Tier 3 

welfare effects testing would be 

determined by EPA on a case-by-case 

basis. Numerous protocols are available. 

Endpoints of concern for aquatic, 

mammalian, and avian toxicology might 

include, but are not necessarily limited 

to, lethal concentrations, effects on 

growth and reproduction, and 

bioaccumulation. Plant toxicological 

endpoints might include growth, yield, 

reproduction, fruit quality, and tissue 

damage or loss. The exposure 

treatments for such tests would be 

administered at expected environmental 

concentrations. 

Specific Tier 3 test requirements 

would be tailored to evaluate the 

potential environmental problems 

identified in Tier 1. For example, if the 

Tier 1 modeling results indicated that 

toxic emissions partitioned to air or soil 

and posed a risk to vegetation. Tier 3 

tests on seedling vigor, life cycle, growth 

and reproduction, and bioaccumulation 

could be required to quantify the risk. 

Similarly, if the pollutants partitioned to 

water, tests relating to fathead minnow 

growth, reproduction, bioaccumulation, 

mortality, or other appropriate concerns 

would be required. Comment on this 

possible approach and other 

alternatives is requested. 

IV. Grouping System for Fuels and Fuel 

Additives 

A. Background and Objectives 

Section 211(e) provides a number of 

mechanisms by which EPA can reduce 

the costs and burdens of compliance 

with the registration requirements set 

forth in section 211(b). In particular, 

section 211(e)(3)(B) permits the 

Administrator to "provide for costsharing with respect to the testing of any 

fuel or fuel additive which is 

manufactured or processed by two or 

more persons, or otherwise provide, for 

shared responsibility" so that the 

program requirements can be met 

without duplication of effort. In 

accordance with this provision, EPA 

intends to establish a grouping system 

which would permit manufacturers of 

similar fuels and fuel additives, on a 

voluntary basis, to pool their resources 

and efforts in satisfying the registration 

requirements described in this NPRM. 

The groups defined by EPA in the final 

rule (unless modified by subsequent 

rulemakings) would be the only groups 

permitted for satisfying the requirements 

of the program. 

To this end, proposed criteria have 

been developed for sorting individual 

fuels and additives into groups of 

related formulations based on 

similarities in their chemical/physical 

composition. The fuels and additives 

within each group are expected to have 

similar emission characteristics and 

thus essentially the same general 

activity with respect to their potential 

effects on the public health and welfare. 

Therefore, chemical or toxicologic 

information associated with individual 

members of a given group can 

reasonably be generalized to all fuels 

and additives in the group, and tests 

perfomed on selected representatives 

can be considered valid for the group as 

a whole. 

While each producer of a fuel or 

additive would still be held individually 

accountable for compliance with the 

registration program, the grouping 

system would provide an opportunity for 

meeting the health/welfare evaluation 

requirements in association with 

manufacturers of similar products. 

Participation in the fuel and fuel 

additive groups would be strictly 

voluntary, and any. manufacturer could 

choose to fulfill the requirements on an 

independent basis. Those who chose to 

take advantage of the grouping 

opportunity would be able to share their 

planning efforts, research capabilities, 

and financial resources in satisfying the 

information-gathering and testing 

requirements of the program. To satisfy 

requirements for chemical and 

biological testing, the required tests 

would be done on one or more 

formulations selected to represent the 

group, rather than being repeated for 

each of the fuels and additives in the 

group. The results of the tests on the 

group representative(s) would be 

submitted jointly for all members of the 

group, with applicable costs to be 

shared by the respective manufacturers. 

Manufacturers who questioned whether 

the results obtained for their group's 

representative(s) were valid for their 

own products could conduct 

confirmatory tests on their products on 

an independent basis and at their own 

cost. However, until such independent 

test results were made available to EPA, 

the original results submitted on behalf 

of the group would be considered valid 

for all member products, and could be 

applied by EPA in risk assessment and 

risk management under CAA section 

211(c). 

The grouping system for fuels and 

additives, is expected to provide a 

number of benefits to the producers and 

blenders who are responsible for 

registration, as well as increasing the 

efficiency and functionality of the 

registration program itself. The primary 

objective of the grouping system is to 

maximize the efficiency of the program 

to the public, the manufacturers, and 
P.18 

Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13183 

EPA First, the grouping system will 

reduce the overall costs of the 

registration program by avoiding the 

unnecessary generation and submission 

of essentially redundant information by 

individual manufacturers with similar 

products. In addition, by reducing the 

number of individual formulations that 

will be subject to testing, the grouping 

system is expected to ease the pressure 

and demands on scarce laboratory 

capacity. Group submissions of test 

results and other registration 

information will also decrease the 

volume of materials which EPA must 

review and process. 

The following sections explain the 

logical approach and functional 

rationale for the proposed grouping 

system and individual group definitions. 

Rules regarding the appointment of 

group representatives for health effects 

testing are also presented. Following 

these sections, issues relating to the 

practical implementation of the grouping 

system are discussed. 

B. Grouping System Rationale 

1. Emissions vs. Raw Product Basis 

Because the information and testing 

provisions of the registration program 

are focused on air pollution effects, the 

fuel/additive groups would ideally be 

defined according to the emission 

products of the fuels and additives 

rather than the chemical composition of 

the raw (uncombusted) fuel and additive 

formulations. Unfortunately, the 

emissions data needed to define and 

carry out an emissions-based grouping 

system will not be available until the 

final rule related to this NPRM has been 

implemented and the new registration 

requirements have been completed by 

fuel and additive producers. Thus, the 

groupings presented in this proposal 

have been defined according to 

characteristics of the raw fuels and 

additives. EPA believes this to be a 

reasonable approach, based on the 

principle that similar raw formulations 

are expected to generate similar 

emission products and, furthermore, that 

the variability which may exist between 

similar fuels and additives will be 

reduced by the process of combustion. 

Comments are requested on the validity 

of using raw product characteristics as 

the fuel/additive grouping criteria for 

this emissions-based testing program 

and the adequacy of this grouping 

approach for evaporative as well as 

combustion emissions. If subsequent 

information indicates that the original 

groupings are inadequate, EPA reserves 

the autiiority to modify them to better 

reflect similarities in emission 

characteristics. In addition, the grouping 

system will be updated as necessary to 

accommodate unanticipated fuel and/or 

additive formulations which may be 

introduced in the future. Such changes 

would be implemented by appropriate 

rulemaking procedures. 

2. Fuel/Additive Relationships 

Because all fuel producers or blenders 

and all additive producers are 

individually responsible for registering 

their products, the possibility of 

duplicative testing for related fuels and 

additives is a problem inherent to the 

registration program. Registered fuel 

formulations nearly always contain a 

Complement of "bulk" additives, 

including performance boosters, 

detergents, rust inhibitors, and other 

agents. In fact, the basic registration 

information submitted for most existing 

fuels has typically included a list of 

many alternative "substantially similar" 

additives within each purpose-in-use 

category, any of which may be 

contained in various formulations of the 

commercially distributed fuel. At the 

same time, these bulk additives must 

also be separately registered by their 

original producers, and are subject to 

the same health/welfare effects 

evaluation procedures that the related 

fuels must undergo. In meeting the 

requirements of this NPRM, each bulk 

additive must be mixed with an 

associated fuel prior to generating' 

emissions for testing. To the extent that 

the resulting additive/fuel mixture is 

similar to existing formulations of fuels 

(with their bulk additive components), 

the health effects tests conducted on the 

emissions of the additive/fuel mixture 

would be duplicative of existing or new 

tests conducted on the related fuels 

themselves. 

Similar overlap exists for aftermarket 

additives which are "substantially 

similar" to their respective fuels. As in 

the case of bulk additives, aftermarket 

additives must be mixed with the 

appropriate fuel prior to generating the 

emissions which will be subject to 

testing under this program. If the 

composition of the additive/fuel mixture 

closely resembles that of the fuel alone, 

testing efforts for the additive and the 

related fuel formulation will be 

redundant. The likelihood of redundant 

efforts is increased by the fact that it is 

the fuel/additive emissions rather than 

the raw fuels and additives which are 

subject to the proposed testing 

requirements. 

To avoid these potential duplication 

problems, the proposed grouping system 

does not require closely-related fuels 

and additives to be segregated into 

separate groups. When the combination 

of an additive and its respective fuel 

results in a mixture that is essentially 

the same as typical commercial 

formulations of that fuel, then the 

additive and associated fuels are 

grouped together. Thus, the producers of 

the fuels and the related additives can 

fulfill their individual registration 

responsibilities through jointlysupported testing of one or more 

formulations representative pf their 

group rather than through duplicative 

independent efforts. That is, the 

requirements for additives which are 

registered as part of a fuel formulation 

can be met in conjunction with the fuel 

producers. Furthermore, other bulk or 

aftermarket additives which have 

essentially the same chemical makeup 

as additive components of fuel 

formulations can also meet their 

requirements in conjunction with these 

fuel products. 

. By grouping similar fuels and 

additives together, the proposed 

grouping scheme also avoids the need to 

define each generic product or product 

component arbitrarily as either a "fuel" 

or an "additive". This problem would 

otherwise arise when a given substance 

(or mixture) can serve as either a fuel or 

an additive. 

A good case in point is methanol. 

Methanol can function as a 

"substantially similar" additive to 

unleaded gasoline or, at higher 

concentrations, as the oxygenating 

additive agent in "reformulated" 

gasoline or diesel fuels. On the other 

hand, there are dedicated methanolfueled vehicles as well as variably- and 

flexibly-fueled vehicles which can make 

use of methanol as their basic 

propellant, in such form as 100 percent 

methanol fuel (M100) or fuel composed 

of 85 percent methanol and 15 percent 

gasoline (M85). 

The approach taken in the 

development of the proposed grouping 

system recognizes that fuel and additive 

formulations are complex mixtures of 

varying proportions rather than pure 

chemical substances. The proposed 

grouping system seeks to categorize fuel 

and additive products according to their 

expected in-use combinations. To the 

extent possible, it does not make 

grouping decisions based upon 

sometimes artificial distinctions 

between fuels and additives. This 

categorization process is further 

explained in the next section. 

3. Grouping Approach 

The basic conceptual framework for 

the proposed grouping system is 

illustrated in Figure 2. In essence, EPA 

has specified seven broad "fuel 

families" and three general "formulation 
P.19 

13184 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

classes. The criteria which define the 

formulation classes" are used to 

subdivide the fuel families into a series 

of "fuel/additive categories." Another 

way to view this relationship is in the 

form of a cross-tabulation, as shown in 

Figure 3. Here, the fuel families serve as 

column headings and the formulation 

classes describe the rows. The resulting 

combinations of fuel families and 

formulation classes (i.e., the boxes in 

Figure 3) are the fuel/additive 

categories. 

Within each category, EPA has 

developed criteria for further 

subdividing the products into "fuel/ 

additive groups". These groups are the 

working units of the grouping system: it 

is among the members of the fuel/ 

additive groups that cooperative 

evaluation and testing efforts can be 

pursued using designated group 

representatives. 

This conceptual framework provides 

some important practical benefits. First, 

it avoids the need to anticipate and 

attempt to define all of the possible fuel 

and additive groups which might be 

required. Instead, generic rules for 

categorization and grouping are 

proposed, and specific fuel/additive 

groups are created in response to the 

product components encountered. The 

proposed framework should also 

facilitate the manufacturer's task of 

assigning a given fuel or additive to the 

appropriate group. The first step would 

entail the selection of the applicable fuel 

family and formulation class for the 

product according to criteria discussed 

below. These selections would define 

the proper fuel/additive category for the 

product. Criteria within each category 

would then be used to determine the 

appropriate group assignment. After the 

group had formed and arrangements 

made for cooperative testing efforts, 

applicable criteria would be applied to 

select a representative of the group to be 

used in group-sponsored testing. 

BILLING COOE 8560-50-M 
Figure 2: Fuel / Additive Classification Hierarchy 

Conventional 

Unleaded Gasoline 

Leaded Gasoline 

Diesel 

Alternative 

Methanol 

Ethanol 

Methane (CNG, LNG) 

Propane (LPG) 

-— Fuel Families X Formulation (.'lasses 

Baseline 

Non-Rust-line 

Atypical 

Fuel / Additive 

Categories 

Fuel / Additive 

Testing Groups 

Group 

Rep-esentatives 

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P.21 

13186 Federal Register / Vol. 57. No. 73 / Wednesday , April 15, 1992 / Proposed Rules 

FIGURE 3.—FUEL/ADDITIVE CATEGORIES 

Formulation 

classes 

(1) Baseline 

formulations. 

(2) Nonbaseline 

formulations. 

(3) Atypical 

formulations. 

"Conventional" fuel families 

Unleaded gasoline 

(A) 

Baseline unleaded 

. gasoline 

category. 

One group 

. represented by 

unleaded base 

fuel. 

V 

Non-baseline 

unleaded 

gasoline 

category. 

-Grouped 

according to 

presence of 

non-baseline 

factors. 

Atypical unleaded 

gasoline 

category. 

Grouped 

according to 

atypical 

elements and 

other 

characteristics. 

Leaded gasoline 

(B) 

Baseline leaded 

gasoline 

category. 

One group 

represented by 

leaded base fuel. 

Non-baseline 

leaded gasoline 

category. 

Grouped 

according to 

presence of 

non-baseline 

factors. 

Atypical leaded 

gasoline 

category. 

Grouped 

according to 

atypical 

elements and 

other 

characteristics. 

Diesel 

(C) 

Baseline diesel 

category. 

One group 

represented by 

diesel base fuel. 

Non-baseline 

diesel category. 

Grouped 

according to 

presence of 

non-baseline 

factors. 

Atypical diesel 

category. 

Grouped 

according to 

atypical 

elements and 

other 

characteristics. 

Methanol 

(>=50%MeOH 

BY VOL) 

(D) 

Baseline methanol 

category.' 

Two groups (M96-

M100 and M50-

M95) 

represented by 

M100 and M85 

base fuels. 

Non-baseline 

methanol 

category. 

Groups TBA 

Atypical methanol 

category. 

"Alternative" 

Ethanol(> =50% 

EtOH BY VOL) 

<

E

» 

Baseline ethanol 

category. 

Two groups (E96-

E100 and E50-

E95) 

represented .by 

E100andE85 

base fuels. 

Non-baseline 

ethanol 

category. 

Groups TBA 

Atypical ethanol 

category. 

Groups TBA 

fuel families 

Methane (CNG, 

LNG) 

(F) 

Baseline methane 

category. 

Two groups (CNG 

and LNG) 

represented by 

CNG and LNG 

base fuels. 

Non-baseline 

methane 

category. 

Groups TBA 

Atypical methane 

- category. 

Propane (LPG) 

(G) 

Baseline propane 

- category. 

One group 

represented by 

LPG base fuel. 

Non-baseline 

propane 

category. 

Groups TBA. 

Atypical propane 

category. 

Groups TBA. 

"Each category contains one or more fuel/additive groups. Hearth effects testing information is required for each such fuel/additive group. 

The key parameters and relationships 

within this grouping framework are 

further explained below. 

Fuel families. Three "conventional" 

and four "alternative" fuel families have 

been defined. Each family consists of a 

constellation of fuel and additive 

products which share basic 

characteristics in regard to their 

chemical/physical properties and 

engine/vehicle applicability. The seven 

fuel families, represented as columns AG in Figure 3, are: (a) Unleaded gasoline, 

(b) leaded gasoline, (c) diesel, (d) 

methanol (containing at least 50 percent 

methanol by volume), (e) ethanol 

(containing at least 50 percent ethanol 

by volume), (f) methane (i.e., 

compressed natural gas and liquefied 

natural gas), and (g) propane (i.e., liquid 

petroleum gas). As shown in Figure 3, 

the unleaded gasoline, leaded gasoline, 

and diesel families are regarded as the 

"conventional" fuel families, while the 

remaining four are referred to as the 

"alternative" fuel families. _ 

EPA expects to define additional fuel 

families in the future as the need arises. 

For example, hydrogen-based fuels have 

not been included in the current 

framework because motor vehicle 

hydrogen fuels and corresponding 

hydrogen-fueled engines are not 

expected to be commercially available 

for several years. However, EPA 

requests comments about the possible 

need for hydrogen or other additional 

fuel families at this time. 

As noted above, a fuel family has 

been defined for leaded gasoline and 

associated additives. However, . 

provisions in the 1990 Amendments to 

the Clean Air Act prohibit the 

manufacture or sale of new leadedfueled motor vehicle engines beginning 

with model year 1993, and ban the sale 

of leaded fuels for on-road use as of 

January 1,1996. Thus, leaded fuels and 

additives will be phased out at about 

the same time that data would be 

submitted under today's proposed rule. 

In view of the upcoming constraints on 

leaded products and the timing of the 

newregistration program's 

implementation, comment is requested 

about die need to include these products 

in the grouping system or, indeed, in the 

new ristration program itself. 

Consistent with the previous 

discussion on fuel-additive 

relationships, each fuel family includes 

not only the fuels referenced in the. 

name of the family, but also bulk and 

aftermarket additives which are 

intended for use in such fuels. Additives 

which can be used in conjunction with 

more than one type of fuel are proposed 

to be assigned to the relevant fuel family 

of which the most gallons of fuel are 

sold relative to the other applicable fuel 

families. An alternative approach would 

require such additives to be tested in 

association with all relevant fuel 

families. Comment is requested on this 

alternative, including the expected costs 

and benefits relative to the proposed 

approach., 

EPA plans to develop sets of chemical 

and physical specifications which will 

represent theoretical "industry average" 

formulations for each defined fuel 

family. These generic formulations, 

called "base fuels" (which will include a 

minimal additive package), will function 

as archetypes of the fuels and additives 

in their families. For fuel additives, 

determination of the proper category 

and group is to be based on the 

properties of the additive/base fuel 

mixture that would result if the additive 

were mixed in its family's base fuel at 

the maximum concentration 

recommended by the additive 

manufacturer. Moreover, prior to the 

generation and testing of additive 

emissions, the additive is to be mixed in 

its base fuel at this concentration. Tests 

conducted on the emissions of the base 

fuel would then serve as controls 

against which.tests on the emissions of 

the additive/base fuel mixture would be 

compared. Base fuels are also proposed 

to serve as representatives in 

compliance with testing requirements 

for some fuel/additive groups. Further 

discussion on the definition and use of 

base fuels is presented in section V.E of 

this NPRM. 
_P.22_ 

Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13187 

~~--r . .-.- ——-m~--rr • r. —" H' ~ * 

Formulation classes. The formulation 

classes serve to subdivide the fuels and 

additives in each family into categories 

according to their similarity to the base 

fuel(s) specified for the family. 

Displayed as rows 1-3 in Figure 3, three 

formulation classes have been defined: 

"baseline", "non-baseline" and 

"atypical". 

(1) The baseline formulation class 

(row 1 of Figure 3) consists of fuels and 

associated fuel additives which 

resemble the respective base fuels in 

terms of their elemental composition 

and their conformity with certain 

quantitative limits for particular 

elements, compounds, or characteristics. 

Baseline formulations in the unleaded 

gasoline and diesel families, for 

example, would contain no elements 

other than carbon, hydrogen, nitrogen, 

oxygen, and sulfur, with limitations on 

die allowable content of oxygen, sulfur, 

and other specified components. 

(2) Fuels and fuel additives in die nonbaseline class (row 2 of Figure 3) would 

contain no elements other than those 

allowed in the baseline class; however, 

they would exceed the concentration 

limits for certain components (or the 

limits on other physical/chemical 

characteristics) which were established 

for the baseline class. For fuel additives, 

this determination would be based on 

die characteristics of the mixture which 

would result if the additive were mixed 

in the appropriate base fuel at the 

maximum concentration recommended 

by the additive manufacturer. 

(3) The "atypical" formulation class 

(row 3 of Figure 3) consists of fuels and 

fuel additives which depart further from 

their respective base fuels in that they 

contain elements other than those 

present in the base fuel or exceed 

specified limits on the amount of sulfur 

allowed. Thus, in the unleaded gasoline 

family, "atypical" formulations would 

be those containing elements other than 

carbon, hydrogen, oxygen, nitrogen, and 

sulfur and those which exceed die 

maximum sulfur content specified for 

baseline formulations. Examples of fuels 

and additives which would potentially 

fall into the "atypical" formulation class 

include those containing compounds 

such as methylcyclopentadienylmanganese-tricarbonyl (MMT), 

organocerium alkanediols, hexafluoroe thy lene diamines, cobalt chloride and 

other halogenated metal oxides, zinc or 

magnesium sulfonates,'ferrous or copper 

sulfates, boron succinamide, and many 

others. 

For the most part, die characteristics 

which define the "atypical" formulation 

class are relatively distinct. In contrast, 

the separation between the baseline and 

non-baseline classes is less obvious. 

The distinction between these two 

classes depends on relative amounts of 

certain components, not the absolute 

presence or absence of such 

components. Since these components 

may be present along a continuum of 

concentrations, it is necessary to 

establish cut-off points which would 

define the amounts considered 

appropriate to the baseline and nonbaseline formulation classes. 

In regard to the "conventional" fuel 

families (gasoline and diesel), EPA is 

considering two basic alternatives for 

distinguishing the baseline and nonbaseline formulation classes. Comments 

are requested from the public on the 

advantages and disadvantages of each. 

For ease of reference, these two 

alternative approaches are termed 

Option A and Option B in the discussion 

which follows. 

Under Option A, baseline and nonbaseline formulations would be 

differentiated on die basis of their 

oxygen and methanol content. In regard 

to oxygen, the baseline class would be 

restricted to formulations having less 

than 1.5 weight percent of oxygen, while 

formulations widi 1.5 percent oxygen or 

more would fall into the non-baseline 

class. Because die cut-off point of 1.5 

percent is consistent with the proposed 

minimum oxygen requirement for 

reformulated gasolines, all reformulated 

gasolines would be assigned tp die nonbaseline formulation class under this 

option. 

The baseline constraint on methanol 

content under Option A would 

correspond to the methanol limitations 

for "substantially similar" fuels (56 FR 

5352, February 11,1991): 0.3 percent 

methanol by volume or, if accompanied 

by an equal volume of butanol or higher 

molecular weight alcohol, up to 2.75 

percent methanol. Formulations which 

exceed diese methanol limitations 

would fall into the non-baseline class. 

Option B would also take oxygen and 

methanol content into account in 

distinguishing baseline from nonbaseline formulations, but would 

establish different cut-off points for 

these factors. The preliminary baseline 

limitations on both oxygen and 

methanol content under Option B would 

correspond to the limitations on these ' 

substances in die "sub sim" rule: oxygen 

would be limited to 2:7 weight percent 

and methanol would be subject to the 

limits cited above for Option A. 

However, fuels and additives which 

exceed these "sub-sim" oxygen or 

methanol limits, but have been waivered 

from associated section 211(f) 

restrictions, would also be included in 

the baseline formulation class. 

Reformulated fuels would thus be 

considered baseline formulations under 

Option B. The non-baseline formulation 

class under Option B would contain 

fuels and additives which are not "sub 

sim" and have not been waivered under 

section 211(f). (It is important to 

recognize that any fuel or additive 

containing an "atypical" element would 

be assigned to the "atypical" 

formulation class, whether or not it has 

received a section 211(f) waiver.) 

Under both Options A and B, 

distinctions between baseline and nonbaseline formulations are also under 

consideration for other fuel and additive 

characteristics, including limits on the 

permissible levels of compounds such as 

aromatics, olefins, and PAHs, as well as 

physical characteristics such as T90 (the 

temperature at which 90 percent by 

volume of a liquid is evaporated). EPA 

asks for comment on whether 

formulations with relatively high levels 

of these substances or characteristics 

should be assigned to the non-baseline 

class and, if so, what specific cut-offs 

should be established for making the 

baseline/non-baseline determinations. 

EPA also asks for comment on whether 

the baseline oxygen limitation is 

appropriate under Option B, or whether 

tighter restrictions should apply, as 

under Option A. To be able to assess 

these options and alternatives, however, 

their potential implications for the fuel/ 

additive categories and groups must first 

be understood. These relationships are 

described in the following sections. 

Categories. As mentioned previously, 

the fuel/additive categories are 

equivalent to die "boxes" in a crosstabulation defined by the intersection of 

the seven fuel families and the three 

formulation classes. For example, as 

displayed in the first column of Figure 3, 

the unleaded gasoline fuel family is 

subdivided into baseline, non-baseline, 

and "atypical" fuel/additive categories 

by the three formulation classes. Some 

of the categories, shown on Figure 3 have 

been defined in anticipation of future 

product introductions and registration 

designations under section 211(a), and 

may not have immediate applicability to 

Ule proposed new registration program. 

The precise specifications of the three 

categories in tiie unleaded gasoline fuel 

family will depend on whether the 

baseline and non-baseline formulation 

classes are defined by Option A or 

Option B. Under either option, the 

definition of the baseline unleaded 

gasoline category would incorporate 

some of the criteria which define 

"substantially similar" products. Fuels 

and additives in the baseline unleaded 

gasoline category would (1) contain no 

elements other than carbon, hydrogen. 
P.23 

13188 Federal Register / Vol. 57, No. 73 / Wednesday, April 15. 1992 / Proposed Rules 

nitrogen, oxygen, and/or sulfur, in the 

form of hydrocarbons, aliphatic ethers, 

and/or aliphatic alcohols, (2) contain no 

more than 0.3 percent methanol by 

volume or, if accompanied by an equal 

volume of butanol or higher molecular 

weight alcohol, up to 2.75 percent 

methanol. (3) contain no more than 1.000 

ppm sulfur, and (4) meet applicable 

volatility class standards published by 

the American Society for Testing and 

Materials (ASTM D4814). 

If Option A were adopted, one 

additional restriction would apply to 

fuels and additives in the baseline 

unleaded gasoline category: Their 

oxygen content would be limited to an 

amount less than 1.5 weight percent. If 

Option B were adopted instead, two 

other specifications would apply. First, 

oxygen content would be limited to 2.7 

weight percent or less. Second, fuels and 

additives which exceeded the 

limitations on oxygen or methanol 

content but received a waiver under 

section 211(f) for these "non-sub-sim" 

characteristics, would be included in the 

baseline category, as long as all other 

baseline criteria were met Additional 

specifications would need to be 

established for the baseline unleaded 

gasoline category if restrictions were set 

on die aromatic, olefin, or PAH content, 

or on the basis of T90. 

Unlike the "sub sim" interpretive rule, 

the specifications proposed for the 

baseline unleaded gasoline category do 

not include -separate criteria for fuel 

additives. In this program, classification 

decisions for additives are to be based 

on the properties of the respective 

additive/base fiiel mixture. Thus, the 

criteria used for sorting fuels into 

categories and groups can also be used 

for additives. 

The non-baseline unleaded gasoline 

category is comprised of fuels (and 

additive/base fuel mixtures) which fail 

to conform to the baseline designation 

because their oxygen and/or methanol 

exceeds the baseline constraints. Under 

Option A, this Category would include 

formulations of at least 50 percent 

unleaded gasoune blended widi 

methanol, ethanol. methyl-tertiary-butyl 

ether (MTBE). ethly-tertiary-butyl ether 

(ETBE). and/or other alcohols and 

ethers, when the total oxygen content is 

at least 1.5 percent Thus, the nonbaseline category would include 

reformulated gasolines as well as a 

number of formulations which have 

previously been granted waivers of 

section 211(f) restrictions. In contrast, 

under Option B. these reformulated and 

waivered gasolines would fall into the 

baseline category. The non-baseline 

category under Option B would, for die 

most part include gasoline formulations 

with oxygen or methanol in excess of 

waivered amounts. Under either option, 

the non-baseline category could contain 

additional fuels and additives if the 

other parameters previously discussed 

were also included in the definition of 

the non-baseline formulation class. 

The third or "atypical" category in the 

unleaded gasoline fuel family includes 

fuels and additives which contain 

elements other than tiiose in the 

baseline category. Thus, the "atypical" 

elements are those other than carbon, 

hydrogen, nitrogen, oxygen, and sulfur. 

Sulfur at concentrations greater than 

1,000 ppm is also considered to be an 

atypical element In many instances, 

products containing these elements are 

"grandfathered" aftermarket additives 

which were allowed to be registered, 

without consideration of their possible 

emission control or other effects, prior to 

the enactment of the 1990 CAA 

Amendments. To generate the emissions 

from such additives for subsequent 

emission characterization and health 

effects testing, the additives will be 

required to be mixed with the base fuel 

designated for the fuel family. The 

results obtained for the emissions of the 

additive/base fuel mixture will then be 

required to be compared to control 

studies conducted on the emissions of 

the base fuel alone. 

The fuel/additive categories in the 

leaded gasoline fuel family are 

conceptually similar to the unle'aded 

gasoline categories. The definition of the 

baseline leaded gasoline category would 

be the same as that for unleaded 

gasoline, except that the criteria would 

include allowable lead content and 

typical halogenated lead-scavenger 

compounds. The non-baseline leaded 

gasoline category would include 

products which exceed the baseline 

limits on oxygen or methanol. 

Criteria for the baseline diesel 

category would also parallel those 

specified for unleaded gasoline, except 

that the limit on sulfur content would be 

0.05 weight percent instead of 1.000 ppm 

and the applicable ASTM standard 

would be ASTM D975. However, the 

definition adopted for the final rule will 

depend on the suitablility for this 

purpose of the new "sub sim" criteria 

now under development for diesel ' 

products (see advanced notice of 

proposed rulemaking, 56 FR 24362, May 

30,1991). The non-baseline diesel 

category would contain products which 

exceed the applicable baseline 

restrictions. Potentially, these would be 

the same as "non-sub-sim" diesel fuels 

and additives. The "atypical" categories 

of leaded gasoline and diesel products 

would include products with elements 

other than those allowed in the 

respective family's baseline category or 

with sulfur in excess of the baseline 

limitations. 

Categories within the "alternative" 

fuel families are shown in columns D-G 

on Figure 3. The baseline categories 

would contain typical M100 and M85 

formulations within the methanol fuel 

family, E85 and E100 formulations 

within the ethanol fuel family, 

compressed and liquified natural gas 

formulations within the methane fuel 

family, and liquid petroleum gas within 

the propane fuel family. There is little 

prospective information regarding "nonbaseline" or "atypical" products which 

may be introduced in these fuel families 

and it is possible that these categories 

will initially be empty. 

Nevertheless, the boundaries between 

the baseline and the other potential 

categories within these four fuel families 

must be established. EPA is considering 

various sets of existing and proposed 

criteria for this purpose, including draft 

ASTM standards for alternative fuels 

and commercial specifications for 

alternative fuels proposed by the 

California Air Resources Board 

(CARB).' Some of these proposed 

specifications are summarized in the 

following paragraphs. However, the 

baseline category definitions which EPA 

adopts for the final rule may vary from 

these proposals, depending on the final 

standards and specifications 

promulgated by these and other 

organizations and the relative 

applicability of any "sub sim" criteria 

for alternative fuels which EPA may 

promulgate in the interim. 

Within the baseline methanol 

category. M100 fuels are proposed to 

contain a minimum of 96 volume percent 

methanol. Up to 2 percent by mass may 

be composed of other oxygenate 

compounds (e.g.. other alcohols and 

ethers) and up to 2 percent may be 

composed of hydrocarbons. The sulfur 

content pf M100 fuel, according to a 

pending ASTM proposal, would be 

limited to 100 parts per million by 

weight (ppmw). M85 fuels would contain 

a minimum of 85 percent methanol by 

volume. The remaining volume would be 

composed of commercial unleaded 

gasoline under the CARB proposal; or of 

unspecified hydrocarbons according to 

the draft ASTM standards. CARB 

proposes a maximum sulfur content for 

9

 Francis, Stephen R. Staff Report: Initial 

Statement of Reasons for Rulemaking. Public 

Hearing to Consider Adoption of Specifications for 

Alternative Fuels for Motor Vehicles. State of 

California Air Resources Board (CARB). Stationary 

Source Division. October 28.1991. 
P.24 

Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13189 

M85 of 150 ppmw because of the 

unleaded gasoline component of the 

fuel, while a 50 ppmw limit is proposed 

by the Motor Vehicle Manufacturers 

Association for certification M85 fuel. 

All baseline methanol fuels would be 

required to contain a flame luminosity 

additive for safety reasons, due to the 

virtual invisibility of a methanol flame. 

The allowable composition of this 

additive would need to be determined 

for the final definition of the baseline 

methanol category. 

Specifications for the baseline ethanol 

category would closely parallel the 

criteria for baseline methanol fuels, 

except that the ethanol must be 

denatured with commercial unleaded 

gasoline before being used in motor 

vehicle fuels. E1C0 would be required to 

have a minimum of 92 volume percent 

ethanol (98 volume percent denatured 

ethanol), with a maximum sulfur content 

of 100 ppmw. E85 would consist of a 

minimum of 81 volume percent ethanol 

(85 volume percent denatured ethanol), 

with sulfur content limited to 150 ppmw. 

In the baseline methane category, 

compressed natural gas (CNG) and 

liquified natural gas (LNG) differ only in 

the manner in which they are 

transported and stored. Otherwise, both 

CNG and LNG fuels would be required 

to contain at least 88 mole percent 

methane, with 8 mole percent ethane 

allowed. Inert gases, principally CO: 

and N2, could comprise up to 5 mole 

percent of the fuel and "other 

hydrocarbons" could make up a further 

3.5 mole percent. 

Liquified petroleum gas (LPG), pr 

propane gas, would be required to 

contain, at a minimum, 80 percent 

propane by volume. GARB proposes that 

it also contain a maximum of 10 volume 

percent propene, while ASTM supports 

a maximum of 5 volume percent. The 

limit for butane and other hydrocarbons 

is proposed to be 2.5 volume percent and 

the sulfur content is restricted to 123 

ppmw. 

Comments and suggestions are 

requested regarding tiie most 

appropriate criteria for distinguishing 

the baseline, non-baseline, and atypical 

categories within the alternative fuel 

families. As EPA acquires edditional 

data on alternative fuel and additive 

formulations, this information will be 

placed in the docket and made available 

for public inspection.. 

Groups. The fuel/additive groups are 

subdivisions of the fuel/additive 

categories, and represent the final level 

of product classification within the 

grouping system. These groups are the 

actual operating units of the grouping 

system. Within each group, one or more 

formulations will be chosen to represent 

all of the member products in 

compliance with the registration 

program's testing requirements. Related 

costs will be shared by participating 

blenders and manufacturers. 

The number of groups defined in a 

particular category of fuels and 

additives depends on die variability 

among the potential products in that 

category and the likelihood that this 

degree of variability would cause 

important differences in their emission 

products. The magnitude of expected 

variability in the emissions of different 

fuels and additives must also be viewed 

in relation to the variations that will 

inevitably be introduced by the emission 

generation system itself. A single fuel/ 

additive formulation will yield 

somewhat different emission products 

depending on the vehicle and engine 

used to generate them, and may even 

differ when the same vehicle is used 

under different operating conditions. 

Thus, absolute precision is not a logical 

goal. Instead, the objective underlying 

the group definitions is to sort fuels and 

additives together when it is reasonable 

to assume that their emission products 

would be essentially the same on a 

qualitative basis. 

Given these considerations, the 

proposed groups and group 

representatives within each of the fuel/ 

additive categories are described in the 

following sections. 

(a) Groups within the baseline 

"conventional" categories. EPA is 

initially proposing that the baseline 

categories in the unleaded gasoline, 

leaded gasoline, and diesel fuel families 

(row 1, columns A-C on Figure 3) each 

be regarded as equivalent to a single 

fuel/additive group. EPA further 

proposes that each of these groups be 

represented in required emission 

characterization and health effects tests 

by the base fuel designated for the 

respective fuel family. Under this 

proposal, the baseline conventional 

fuel/additive groups would be very 

large, and each of the respective base 

fuels would potentially be used to 

represent hundreds of products. Thus, 

two alternative approaches are under 

consideration. . 

The first alternative would retain the 

concept of a single group for each 

baseUne fuel/additive category, but 

would increase the number of 

representatives for each such group. For 

example, the baseline unleaded gasoline 

group might be represented by three 

base fuels, corresponding to regular, 

mid-grade, and premium formulations. 

Likewise, the diesel group might be 

represented by both D-1 and D-2 base 

fiiel formulations. In addition, 

appropriate commercial formulations 

could be selected as representatives 

reflecting extremes in aromatic, olefin, 

or PAH content. If the baseline 

categories and groups were defined 

under Option B, consideration might 

also be given to the designation of 

selected oxygenated fuels as additional 

group representatives. 

In practice, however, the designation 

of more than one representative per 

group would run counter to the general 

approach in the program that adequate 

existing information for any product in a 

given group can be used to satisfy the 

associated testing requirement for all 

products in the group. If adequate 

testing had previously been done, say, 

oh one of the representatives of a group, 

these test results could be applied to all 

products in the group, including the 

other representatives. Therefore, full 

testing would not be required for each 

representative. 

The second alternative would avoid 

this result by splitting the baseline fuel/ 

additive categories into more than one 

group. Under this approach, the baseline 

unleaded gasoline category could be 

divided, say, into three groups (regular, 

mid-grade, and premium) and the diesel 

category into two groups (D-1 and D-2). 

Other groups, based on the factors 

previously discussed, would also be 

possible. A corresponding base fuel or 

selected member product would be 

designated to serve as the 

representative for each group. This 

approach would require die submittal of 

a complete set of test information, either 

existing or new, for each of these 

classifications. However, most .of the 

previous testing on products in the 

baseline categories has made use of 

regular gaoline and D-2 diesel fuels. As 

a result, the other potential groups in 

these categories would largely be 

precluded from using existing test data 

for compliance with program 

requirements. EPA asks for comment on 

these various options for defining the 

baseline conventional fuel/additive 

groups and their representatives.-

(b) Groups within the non-baseline 

"Conventional" categories. EPA 

proposes to subdivide the non-baseline 

categories of unleaded gasoline, leaded 

gasoline, and diesel products (row 2, 

columns A-C on Figure 3) into different 

working groups based on the specific 

compound(s) present in the formulation. 

In the non-baseline unleaded gasoline 

category, for example, separate groups 

are proposed for gasoline formulated 

with methanol alone, ethanol alone, 

MTBE alone, ETBE alone, and other 

individual alcohols and ethers. Products 

containing combinations of oxygenate 

compounds would be assigned to 
P.25 

13190 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

additional groups, with separate groups 

defined for each combination present in 

one or more product formulations. 

Among currently registered fuels and 

fuel additives, EPA estimates that this 

proposal would produce 17 groups in the 

non-baseline unleaded gasoline category 

and one group in the non-baseline diesel 

category, assuming Option A were used 

to define the formulation classes. 

Within each of these groups, the 

member fuel or additive/base fuel 

mixture containing the highest total 

weight percent of oxygen would serve 

as the group representative. In case of 

"ties" within a given group, the 

proposed regulations contain decision 

•criteria for selecting the representative 

product based on the proportion of the 

total oxygen content which is 

contributed by particular oxygenate 

compounds. The proposed criteria give 

precedence to oxygenate compounds in 

the following order: 

(1) Methanol, 

(2) Ethanol, 

(3) Tert-butyl alcohol (TBA or GTBA), 

(4) MTBE, 

(5) Tert-amyl-methyl-ether (TAME), 

(6) ETBE, 

(7) Isopropanol, 

(8) Isopropyl ether, 

(9) Other alcohols, 

(10) Other ethers. 

Some would argue that the groups 

proposed within the non-baseline 

categories are so narrowly defined that, 

in some cases, the exhaust emissions 

from products in different groups will 

probably be indistinguishable. At the 

current time, EPA is unaware of detailed 

emission speciation tests on various 

oxygenated formulations which would 

support this theory. However, it might 

be possible to establish programmatic 

mechanisms which would allow some 

groups to be collapsed for purposes of 

studies on the health effects of 

combustion emissions, if the results of 

speciation tests indicated that the 

emissions from the representative 

products in different groups were the 

same. Such mechanisms would need to 

include speciation results on the 

emissions from a sufficient number of 

vehicles that objective statistical 

conclusions could be reached regarding 

the emissions variability. Comments and 

suggestions on these issues are 

welcome. 

Depending on the final definitions 

adopted for the baseline and nonbaseline formulation classes, the nonbaseline categories may contain fuels 

and additives with distinguishing 

characteristics other than oxygenate 

components. As mentioned previously, 

three such factors under consideration 

are aromatic, olefin, and PAH content. 

In these instances, the definition of 

groups and group representatives would 

follow principles similar to those 

applied above. To use aromatic content 

as an example, and applying the 

principles presented in the supporting 

regulatory text, individual compounds of 

concern would be grouped separately; 

however, if two compounds of concern 

were present, the representative would 

be that with the greater proportion of 

the heavier weight aromatics (e.g., 

greater weight given to nine-carbon than 

seven-carbon compounds). 

(c) Groups within the "Atypical" 

gasoline and diesel categories. For fuels 

and additives in the "atypical" gasoline 

and diesel categories (row 3, columns 

A-C on Figure 3), EPA proposes to 

define a relatively, large number of 

distinct groups according to the 

element(s) which caused these products 

to be categorized as atypical. First 

separate groupings would be established 

for any single atypical element and any 

unique combination of atypical elements 

which occurred among the products in 

each category. These groupings would 

then be further subdivided according to 

the presence or absence of polymers 

and the presence or absence of oxygen 

in an amount greater than the baseline 

amount. 

For currently registered fuels and 

additives, EPA estimates that this 

approach would result in 48 "atypical" 

unleaded-gasoline groups and 47 

"atypical" diesel groups. Comments are 

requested concerning this proposed 

grouping scheme and possible 

alternative approaches. For example, 

comment is requested on the necessity 

of establishing separate groups for each 

unique combination of "atypical" 

elements and conditions, as is proposed. 

Alternatively, it might be possible to 

define some reasonable rules of 

precedence which would allow products 

containing certain combinations of 

"aytpical" characteristics to be grouped 

with products containing only one of 

these characteristics. Such an approach 

would decrease the total number of 

groupings and would increase the 

number of potential products in each 

group. Suggestions are also welcome in 

regard to additional variables (e.g., 

aromatic content or the presence of 

specific oxygenate compounds) which 

should be taken into account in defining 

groups of atypical products, recognizing 

that each new factor could increase the 

number and decrease the size of the 

resulting groups. 

For each group, the representative to 

be used in satisfying the group's testing 

requirements is proposed to be the 

member product with the highest 

concentration of atypical elements. In 

case of ties, a process for selecting the 

representative is proposed which would 

give precedence to the relevant 

characteristics in the following priority 

order 

(1) Total metals, 

(2) Total halogens, 

(3) Total of other atypical elements, 

(4) Total oxygen content, 

(5) Polymer content. 

EPA has proposed that the 

representative be selected to reflect the 

highest concentration of atypical 

elements so that, if subsequent tests are 

negative, these results can safely be 

generalized to all group members. If, 

instead, the representative were chosen 

to reflect the average or median 

concentration of atypical elements 

among products in -the group, the 

significance of negative test results 

would be unclear for group members 

with higher concentrations of atypical 

characteristics. In case a particular 

group contains products which generally 

reflect a distinct clustering of 

concentrations plus one or more 

products with much higher 

concentrations, the associated 

manufacturers may choose to divide the 

group on this basis to prevent a distant 

"outlier" from serving as the 

representative for all. 

(d) Groups within the baseline 

"Alternative"Categories. Within the 

baseline methanol category, EPA 

proposes to establish two fuel/additive 

groups. One group would include M100 

formulations (containing at least 96% 

methanol) and would be represented by 

a designated M100 base fuel 

formulation. The second group would 

consist of methanol/gasoline blends 

containing 50-96% methanol. The latter 

group would be represented by a 

designated M85 base fuel, reflecting the 

expected preponderance of end-use 

formulations in this group. 

Because EPA has little experience 

with formulations in the ethanol, 

methane, and propane fuel families, 

suggestions from the affected industry 

organizations are requested in regard to 

appropriate numbers of groups and 

representatives for the baseline category 

in each of these families. At this time, 

EPA proposes to define two groups 

within the baseline ethanol category, 

defined in parallel to the two methanol 

groups described above. The baseline 

methane category is also proposed to 

contain two groups (CNG and LNG), 

whilethe baseline propane category 

would constitute a single group. 

Depending on the rapidity with which 

products in these categories are 

introduced into the marketplace, and the 

timetable for implementation of 
P.26 

expected regulations requiring the 

registration of these products, it may be 

possible to define baseline ethanol (E85 

and E100), CNG. LNG. and LPG 

formulations to serve as the respective 

group representatives in time for the 

final rule related to this proposal. 

Alternatively, if products in these groups 

are not registered until after publication 

of the final rule, it may be necessary to 

designate the first commercial fuel to 

seek registration in each group as the 

prospective representative for similar 

products seeking registration at a later 

time. In that instance, technical 

amendments could be published 

defining the specific product formulation 

criteria which would be used to 

detennine when producers of later 

products could rely on the testing 

information submitted for the first 

product in satisfaction of their own 

registration requirements. A time limit 

for the initial registrant's right to 

reimbursement would also need to be 

established. Comment is solicited on 

these topics. 

(e) Groups within the "Non-Baseline" 

and "Atypical" "Alternative" 

categories. With respect to products 

which may fall into the "non-baseline" 

and "atypical" methanol, etiianol. 

methane, and propane categories (rows 

2 and 3, columns D-G on Figure 3), EPA 

must defer the devlopment of applicable 

groups until information on the nature of 

these future products becomes 

available. As a practical matter, such 

groups are likely to be defined in 

response to proposed new product 

introductions rather than in advance of 

their introduction. As described above 

in regard to the baseline alternative 

fuels, the first manufacturers of atypical 

products in these categories to satisfy 

the testing and other registration 

requirements would have the right to 

seek reimbursement from manufacturers 

of other products who wished to rely on 

the first manufacturer's data for 

registering subsequent similar products. 

EPA would welcome comments on these 

proposals and on alternative 

mechanisms for defining and 

establishing groups within these new 

fuel/additive categories. 

4. Alternatives for Group 

Responsibilities 

In the approach described above, a 

designated representative would 

represent the members of a fuel/ 

additive group in compliance with all 

health effects testing requirements, 

including both the Tier 1 requirements 

for chemical speciation of emissions and 

the biological testing requirements of 

Tiers 2 and 3. An alternative approach 

would require all unique fuel and 

additive formulations to undergo 

emission characterization 

independently, applying the group 

representative principle only in regard 

to biological testing requirements. This 

approach would provide more definitive 

information on the emission products of 

each fuel and additive, but would 

increase program costs to individual 

manufacturers and would increase 

demands on scarce commercial 

laboratory capacity. EPA requests input 

from the public on the likely benefits 

and costs of imposing separate emission 

speciation requirements for each fuel 

and additive as compared to requiring 

the emissions data only for the 

designated group representative. . 

C. Grouping System Implementation 

Issues 

The practical implementation of the 

grouping system involves two major 

tasks: the organization and 

administration of group functions, and 

the development of equitable 

arrangements for cost sharing. Backed 

by its experience with respect to the 

TSCA testing program, EPA believes 

that the fuel/additive industry, under 

the aegis of its various trade 

associations or other third parties, is 

capable of accomplishing these tasks 

with little or no Agency assistance and 

interference. However, effective 

operations will be critical to the overall 

success of the grouping provisions of the 

registration program, and suggestions 

from the industry are invited as to 

practical ways in which EPA may be 

able to facilitate the implementation of 

the rule. 

1. Organizational Tasks 

The primary organizational task is the 

formation of consortiums of refiners and 

manufacturers whose products are 

potential members of the same EPAdefined fuel/additive groups. This task 

will entail the development of 

procedures which will allow 

manufacturers who wish to participate 

in group functions to locate and form 

working associations with other 

manufacturers of products which fit the 

same grouping criteria. While willing to 

provide a limited amount of support, 

information, and guidance when 

necessary, EPA does not intend to 

determine the proper group for each fuel 

and additive, nor to inform the 

manufacturer of that group assignment 

Rather, manufacturers will be expected 

to determine the appropriate groups for 

their products independently, according 

to grouping criteria published in the final 

rule, and to enroll their products into 

those groups under industry-sponsored 

brokering mechanisms. EPA expects 

manufacturers to comment on the 

grouping scheme in this proposal and 

does not intend to address special 

requests for exceptions to the grouping 

scheme after the final rule is 

promulgated. 

Once the group members have been 

identified, administrative agreements 

will need to be reached concerning the 

division of responsibilities among the 

respective manufacturers for meeting 

the specific requirements of the 

registration program and for preparing 

the joint submittal of test results and 

other information to EPA. To meet the 

program's literature search requirements 

and fo document the extent to which 

existing test results are adequate to 

mitigate new testing requirements, 

arrangements may be needed for sharing 

in-house health effects test data and 

compiling additional information from 

published sources. For new testing, 

administrative arrangements will need 

to be reached with respect to the 

selection and/or formulation of the 

designated representative product(s) to 

be tested, the acquisition of vehicles 

required for emission generation, the 

identification of qualified personnel and 

laboratories to conduct the tests, and 

the establishment of quality assurance 

mechanisms which will ensure that 

procedures and protocols are performed 

according fo acceptable standards. 

Some groups, especially those in the 

baseline conventional fuel/additive 

categories, will potentially be very large, 

and considerable coordination effort 

may be required. 

The task of organizing the fuel/ 

additive groups will be complicated by 

the fact that the respective producers 

will sometimes be competitors in the 

same specific market segment and that 

even the identification of a product as a 

potential member of a given group may 

reveal information that a producer 

would prefer to keep confidential. 

Industry trade associations may be able 

to establish "third-party" mechanisms 

whereby individual manufacturers can 

enroll their products in appropriate 

groups while minimizing the extent to 

which confidential data must be 

revealed. Each producer will need to 

determine whether the cost-sharing 

advantages provided by group 

participation outweigh the possible 

competitive risks involved. However, 

whether a manufacturer chooses to 

participate in group functions or to 

satisfy the registration requirements 

through independent testing, section 

211(b)(2) stipulates that "the results of 

such tests shall not be considered 

confidential". 
P.27 

13192 Federal Register / Vol. : 73 / Wednesday , April 15, 1992 / Proposed Rules 

2. Cost-Sharing Provisions 

The main purpose of the proposed 

grouping system is to apply section 

211(e)(3)(B), which permits producers 

who manufacture or process the same 

fuel or fuel additive to share the 

responsibilities of the program so that 

requirements can be met without 

duplication of cost and effort. EPA has 

had extensive experience with costshared testing conducted by 

manufacturers in compliance with 

regulations under TSCA Section 4. To 

date. EPA has found the persons 

conducting tests under Section 4 have 

chosen in each instance to work out 

their own arrangements for cost-sharing 

or reimbursement without any need for 

EPA involvement. While formal data 

reimbursement regulations were issued 

for this purpose in 40 CFR part 791. no 

one has yet invoked the procedures 

therein. 

EPA believes that a similar result 

would be likely if cost-sharing rules 

were promulgated within the fuels and 

fuel additives registration program. At 

this time, therefore. EPA proposes to 

leave the development of specific costsharing agreements up to the 

participating manufacturers. However, 

comments are solicited concerning the 

potential need for EPA involvement in 

these arrangements. If such involvement 

is deemed necessary, opinions are 

requested on the adequacy of existing 

TSCA regulations for this purpose or an 

alternative cost-sharing guidelines or 

procedures. 

One possibility under consideration 

would require manufacturers of existing 

fuels and fuel additives to notify EPA 

within one year after publication of the 

final rule if they intended to comply 

with the rule as part of a group and. if 

so, to identify the person or entity which 

was organizing the testing. For new fuels 

and fuel additives, manufacturers would 

be required to conduct the testing 

individually unless they first certified to 

EPA that they intended to rely on data 

previously submitted by a manufacturer 

of a similar product. The certification 

would need to include assurances that 

the first manufacturer had been notified 

of this intent and that the first 

manufacturer has the right to 

reimbursement under procedures such 

as those specified at 40 CFR part 791. 

Comments on these possible 

mechanisms are requested. 

Arrangements for cost-sharing will 

need to account for two general 

situations. In one case, groups of 

producers would organize prospectively 

to complete the same program 

requirements for their similar products. 

In this instance, cost-sharing 

arrangements could be reached in 

advance of testing. Such arrangements 

might divide the program costs on a perproduct basis or in proportion to 

applicable market share, sales revenue, 

production volume, and/or other 

relevant parameters which participating 

manufacturers agree would be equitable. 

The second situation involves the 

case where adequate information 

already exists for the registration of a 

product because the required tests have 

been completed by another 

manufacturer (or group of 

manufacturers) on similar products (i.e., 

products meeting the criteria for 

membership in the same group as the 

new product). In this instance, the costs 

of program compliance would already 

have been incurred, and a manufacturer 

with a similar product wishes to reply 

on this existing testing in satisfaction of 

the registration requirements for his 

similar product. EPA proposes that, to 

use the existing test results, the new 

manufacturer would be required to 

notify the existing manufacturer that he 

has used the data snd apprise him of his 

right to be reimbursed EPA invites 

comments on whether these 

arrangements should be left to the 

producers to work out among 

themselves. Alternatively. EPA rules 

could be promulgated specifying the 

computation of reimbursement fees and 

the number of years that reimbursement 

rights would remain in effect. In that 

instance. EPA proposes that the 

"ownership" period for registration 

information should last for five years 

after data submission. To be reimbursed 

when new producers seek to rely on 

their existing data for fuel/additive 

registration, the original producers (or 

groups of producers) would be required 

to document the costs already incurred 

in conjunction with the registration 

program's informationgathering and 

testing requirements. Tne level of 

reimbursement would be determined 

according to the applicable costs and 

the number of producers relying on the 

information for registration purposes. 

Comments are requested about the 

suitability of these or other alternative 

reimbursement arrangements. 

V. Emission Generation 

As discussed in section III.E, the 

proposed requirements for evaluating 

the potential emissions-based health 

and welfare effects of fuels and fuel 

additives include analytic procedures in 

Tier 1 for characterizing the chemical 

composition of fuel/additive emission 

products, as well as biological studies in 

Tiers 2 and 3 involving the exposure of 

laboratory animals to fuel/additive 

emissions. This section presents the 

methods proposed for generating, 

storing, and sampling the emissions to 

be used in these chemical and biological 

tests. With a few noted exceptions, 

emissions will be generated according to 

the Federal Test Procedures (FTP) for 

light-duty vehicles (40 CFR part 88). 

A. Vehicle Requirements 

1. Vehicle Selection 

Because the composition of emissions 

produced by a given fuel or additive is 

likely to vary somewhat depending on 

the vehicle involved, a fully 

comprehensive testing program would 

need to encompass the emissions from 

many vehicles representing a complete 

cross section of the in-use fleet. In the 

context ofthe proposed Reformulated 

Gasoline Rulemaking. EPA suggested 

that to obtain a statistically significant 

set of emission characterization results 

encompassing the variety of emission 

control systems available, emissions 

would need to be generated from at 

least 20 vehicles for each fuel under 

evaluation (see Supplemental Notice of 

Proposed Rulemaking, available in 

Docket # A 91 02). For purposes of the 

routine registration of motor vehicle 

fuels and fuel additives, however. EPA 

believes that such an extensive emission 

sampling and testing scheme may not be 

reasonable or necessary. EPA is initially 

proposing that only one vehicle be 

required to generate the emissions to be 

used for the chemical and biological 

testing included in Tiers 1 and 2, while 

potential Tier 3 requirements might call 

for the use of additional vehicles. 

Alternatives to this basic proposal are 

discussed later in this section. 

Similar to the reformulated gasoline 

proposal, the parameters to be 

considered in specifying the vehicles to 

be used for emission generation include 

vehicle class, emission control 

equipment, and vehicle sales volume. 

First, for each fuel family, the vehicle 

class and subclass to be used for 

emission generation will be that which 

reflects the highest yearly amount of 

consumption of fuels in that family. 

Normally, vehicle classes include lightduty vehicles (LDV). light-duty trucks 

(LDT). and heavy-duty vehicles/engines. 

For purposes of this program, however. 

EPA proposes that LDV and LDT be 

combined into one vehicle class. LDT 

represent a large fraction of the gasoline 

fuel consumed in the U.S.. but less than 

the fraction attributable to LDV, Thus, if 

LDV and LDT are maintained in 

separate classes. LDT would probably 

not be selected for generating emissions 

from gasoline fuels and fuel additives. 

Although LDV and LDT are expected to 
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Federal Kegister / Vol. 57, No. 73 / Wednesday, April 15, 1992./ Proposed Rules 

produce similar emissions, reflecting the 

fact that their engines, emission control 

systems, and emission standards are 

similar, the absence of LOT in the 

program might still reduce the 

representativeness of the test emissions 

for gasoline fuels and fuel additives. 

Comment on whether or not LDV and 

LDT should be combined into one 

vehicle class would be appreciated. 

In view of the overwhelming 

proportion of total diesel vehicle miles 

wliich are traveled by heavy-duty diesel 

vehicles, heavy-duty engines are 

expected to be used to generate test 

emissions for diesel fuels and fuel 

additives. Because of the lack of heavyduty vehicle testing faciUties, however, 

emission generation using light-duty 

vehicles of the same fuel class may be 

preferable from the standpoint of 

practicality. Comments are requested on 

this issue. 

The next step is fo determine the 

selection criteria for specific vehicle 

models. The vehicles to be used for 

emission characterization must be new 

vehicles of the model year in which 

testing begins. However, vehicle 

selection criteria are to be based on 

technology characteristics of the 

previous model year. The group or 

company seeking registration would first 

detennine the most common fuel system 

and emission control system 

combination in the applicable vehicle 

class. The criteria to be considered for 

light-duty gasoline powered vehicles, for 

example, might be fuel metering 

approach (carburetted, fuel injected 

(port, throttle body) and emission 

control approach (catalyst type, air 

injection, exhaust gas recirculation 

(EGR). feedback control, etc.). The 

company could then select for testing 

any one of the fop five selling models 

with these characteristics, based on the 

previous model year's sales. If any of 

the five selected models were not 

available in the model year when the 

new vehicle was to be purchased for 

testing, the selection would be limited to 

the models remaining. 

In general, the vehicle selection 

criteria described above would be used 

to determine the representative vehicles 

for all fuel families. However, fewer 

than five vehicle models may be 

available for "alternative" fuel families. 

In such.instances, any available model 

could be used for testing. The proposed 

vehicle selection procedure is more 

thoroughly described and illustrated in a 

memorandum entitled, "Vehicle 

Selection Procedures for the Proposed 

Fuels and Fuel Additives Rulemaking," 

available in the public docket. 

Comment is requested on how to 

determine the types of vehicles that 

should be used fo test fuels and 

additives which are not commonly used 

or intended to be used in the vehicle 

type which the standard vehicle 

selection procedure would prescribe. 

This situation might arise, for example, 

in the selection of vehicles for testing 

lead substitute aftermarket additives 

(which may damage vehicle catalysts) 

and for testing number 1 diesel fuel 

(most commonly used in urban buses). 

2. Mileage Accumulation Requirements 

Mileage accumulation is important for 

this program for two primary reasons: It 

"breaks in" a new vehicle so that the 

emissions stabilize (an effect which is 

independent of the fuel used in the 

vehicle) and if allows potential longterm effects of the fuel or additive on 

emissions fo be assessed. Suggestions 

for the amount of mileage accumulation 

appropriate for this program have 

varied. Some have suggested thaf the 

minimum mileage needed to "break in" 

a new vehicle (approximately 4,000 

miles for light-duty vehicles) would be 

sufficient for this program, claiming that 

the fuels used in the vehicle do not 

drastically affect the emissions of a 

vehicle. Others have suggested that 

emission characterization be continued 

throughout the useful life mileage of the 

vehicle (50,000 miles for light-duty 

vehicles, changing to 100,000 miles in 

1994) in order to determine the full 

effects of the fuel or additive being 

tested. Another advantage gained by 

requiring a significant amount of 

mileage accumulation is that it reduces 

the chance of "gaming" the test results 

by discouraging the testing of a number 

of vehicles and selection of the best 

results. Therefore, EPA proposes 25,000 

miles as the minimum mileage which 

must be accumulated using the subject 

fuel or additive/base fuel mixture before 

testing is conducted. This value reflects 

a point between the two positions that 

provides a reasonable opportunity for 

long-term effects of the fuel or additive 

to be revealed, while at the same time 

avoids undue burden; As will be 

discussed further below in sections V.D 

and VI.A.2.f, additional mileage may be 

necessary for fuels and additives 

containing atypical elements. Comment 

with supporting data is requested 

regarding the appropriate mileage 

accumulation requirements for vehicles 

used in the testing of baseline/nonbaseline and atypical formulations. 

The proposed mileage accumulation 

would be required td begin when the 

vehicle was new, using only the fuel or 

additive/base fuel mixture of interest. 

Mileage could be accumulated by any 

appropriate means. For example, the 

vehicle could be placed in the 

company's fleet, held for controlled fleet 

use, or driven on the street, test track, or 

dynamometer solely for the purpose of 

mileage accumulation. Vehicles would 

be required fo be unmodified and 

maintained as instructed in the vehicle 

owner's manual. 

3. Alternative Approaches 

As stated earlier, a comprehensive 

determination of the emissions from a 

fuel or additive could require testing the 

emissions from af least 20 vehicles, and 

EPA request comment on whether 

testing emissions generated by only one 

vehicle is sufficient fo screen for 

representative emission compounds and 

their related biological effects in this 

program. EPA is considering a 

compromise between testing one vehicle 

and testing 20 vehicles, in which 

perhaps three to six vehicles, 

representing differing emission control 

technologies, would be used to generate 

emissions for emission characterization 

purposes. One of these vehicles, or 

perhaps a combination thereof, would 

be chosen fo generate emissions for 

biological testing. 

Another possible variation in the 

proposal would allow in-use vehicles 

which have already accumulated 

sufficient mileage to be employed for 

generating emissions instead of 

requiring mileage accumulation on new 

vehicles. While this alternative would 

reduce compliance costs, it has some 

possible drawbacks. Long-term emission 

effects caused by the fuels and additives 

previously used in these vehicles could 

alter the generated emissions and 

therefore the emission characterization 

and biological test results. It would then 

be difficult to assess the extent fd which 

the test fuel was responsible for the test 

results. Another drawback is the 

absence of information on the long-term 

effects of the tesf fuel or additive. 

Finally, gaming could occur such that, 

emmission characterization could be 

performed on many vehicles and only. 

the best results submitted. Comment is 

requested on'whether in-use vehicles 

would be acceptable for this program. 

:

 EPA has also identified an alternative 

emission generation scenario which 

incorporates a number of the possible 

program modifications described above. 

Because this scenario would require the 

use of more vehicles in the testing 

program in order to increase the 

confidence that can be placed in the 

results, methods of reducing other 

associated costs have also been 

identified. 

First, with regard to fuels and 

additives that do not contain an atypical 

element (i.e., those in the baseline and 
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13194 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

non-baseline formulation classes), the 

required number of vehicles would be 

increased from one to six. The vehicle 

selection criteria would include the 

same emission control system 

characteristics as described previously, 

except that six technology groups would 

be determined from the emission control 

system combinations, and the top seller 

from each group would be included in 

the program. 

To reduce costs, mileage 

accumulation requirements per vehicle 

would be reduced, perhaps to the 4,000-

10.000 mile range. The use of new 

vehicles would be encouraged, but inuse vehicles would be permitted after 

specified intermediate preconditioning, 

assuming that the fuel or additive 

producer was willing to accept the 

program outcome risk of using vehicles 

which had been operated on other fuels 

and additives. 

A prime tenet of this approach is that 

emissions carryover from the use of one 

fuel or additive to another in the same 

vehicle can be eliminated by an 

intermediate preconditioning process. 

This would pennit one vehicle to be 

used to generate emissions for more 

than one product. One potentially 

applicable intermediate preconditioning 

method has been used in the Joint Auto/ 

Oil Air Quality Improvement Program. 

Additional discussion on 

preconditioning methods is available in 

a memorandum in the public docket. 

EPA asks for comment on the validity of 

the assumption that fuel emission 

carryover effects can be eliminated with 

a reasonable amount of intermediate 

preconditioning. 

A valid preconditioning process 

would not only pennit previously used 

vehicles to be employed in the testing 

program, but would also allow the same 

vehicles to be used for testing more than 

one product. For example, the proposed 

testing of fuel additives requires the 

emissions of an additive/base fuel V 

mixture to be compared witii the 

emissions of the base fuel alone. This 

could be accomplished by performing 

one set of emission characterization 

control tests on the base fuel in each of 

the six vehicles. Then, with intermediate 

preconditioning, the same set of six test 

vehicles could be used to perform 

emission characterization for any 

number of fuel additives in the same fuel 

family, excluding those with "atypical" 

elements. In this way, only one set of 

base fuel emission characterization 

results would suffice for all products 

that underwent testing using the same 

set of vehicles. 

Specific fuel formulations subject to 

testing would also be required to 

undergo emission characterization using 

six vehicles. Comment is requested as to 

whether producers testing these specific 

formulations should, for comparison 

purposes, also be required to test the 

applicable base fuel using the same six 

test vehicles (assuming that the fuel 

being tested is not itself a base fuel). 

Under this scenario the incremental 

expense would be expected to be small. 

As was mentioned above, a specified 

intermediate preconditioning cycle 

would have to be performed at the time 

the vehicle is switched between 

different fuels, additive/base fuel 

mixtures, or the base fuel. 

Once the emission characterization 

was complete, one of the same six test 

vehicles would be selected and used to 

generate emissions for.biological testing. 

The selection of this vehicle would be 

based on analysis of the emission 

characterization data. A number of 

alternative selection criteria are 

possible. For example, the vehicle could 

be chosen to represent either the 

average or highest emission rate of 

volatile organic compounds, total 

toxicants, particulate matter, and/or 

PAH. EPA would appreciate comment 

on the parameters that should be used to 

select the vehicle to be used for 

emission generation for biological 

testing. Another possibility would be to 

use all six vehicles, with each vehicle 

generating emissions for one-sixth of the 

testing time period. 

For fuels and additives in the atypical 

formulation class, the atypical elements 

potentially have a much greater chance 

of affecting the vehicles' emission 

control components, making long-term 

emission effects much more likely. Thus 

longer mileage accumulation to steady 

state may be necessary. Furthermore, 

multiple use of vehicles may not be 

possible because the intermediate 

preconditioning process may not be 

effective at eliminating potential 

carryover effects of the atypical 

elements. To increase confidence in the . 

results of the testing, six vehicles 

selected as described above would be 

required to accumulate mileage. In order 

to isolate long-term effects, EPA ' 

proposes to require the use of new 

vehicles, but asks for comment on 

whether low mileage used vehicles 

would be an acceptable alternative. 

Emissions from all of the test vehicles 

would be characterized, and these * 

results would be compared with die 

baseline group representative of that 

fuel class (see section V.E.2). 

Finally, two alternatives have been 

identified for conducting biological 

testing on group representatives in the 

atypical formulation class. Under the 

first alternative, only one of the vehicles 

would be chosen to undergo further 

mileage accumulation to reach steady 

state (e.g., the vehicle with the highest 

atypical element emission rate of the six 

vehicles). Then, speciation of the 

emissions containing atypical elements 

and the required biological tests would 

be performed. Under the second 

alternative, all of the vehicles would 

need to reach steady state. Speciation of 

the atypical emissions would then be 

done for all six vehicles. Biological 

testing could be done either on one 

selected vehicle, or each vehicle share 

in the emission generation for biological 

testing (as was discussed above for the 

baseline and non-baseline formulation 

classes). EPA solicits comments on 

these scenarios designed to costeffectively generate the data required by 

the statute. 

B. Combustion Emission Generation 

The FTP through the exhaust 

emissions test is the method proposed 

for generating the combustion emissions 

needed to meet the emission 

characterization requirements of Tier 1. 

These procedures are specified in 40 

CFR part 86 for the certification of new 

motor vehicles, and may vary depending 

on the fuel family and vehicle class. 

Consistent with .the current FTP 

requirements, canister loading during 

the FTP preconditioning phase must be 

done by methods that use actual 

evaporative emissions rather than bench 

methods, which use a surrogate 

compound for canister loading. This will 

help to ensure that emissions are 

generated exclusively from the fuel or 

additive being tested. Modifications to 

the standard FTP will be needed to 

collect particulate and semi-violatile 

emissions, which are required both for 

emission characterization and in vitro 

biological testing. The particulate 

fraction is to be collected on filters and 

the semi-volatile emissions collected 

immediately downstream from these 

filters, using porous polymer beds or 

other equipment designed for their 

capture. 

After collection, the organic fraction 

of the particulate and semi-volatile 

emissions would be extracted 

separately from each other using 

appropriate laboratory procedures. 

Because the extracted materials would 

be much more stable than gaseous 

combustion emissions, they could be 

stored for longer periods of time before 

use. For this reason, the particulate and 

semi-volatile emissions could be 

generated and used in different 

locations, as long as proper handling 

techniques were observed. 

For in vitro biological testing 

purposes, the particulate emissions may 
P.30 

Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13195 

be collected on a single filter instead of 

on multiple filters as prescribed in the 

FTP. Similarly, semi-volatile phase 

emissions may be collected on one 

apparatus for the entire driving cycle. If 

an insufficient amount of particulate or 

semi-volatile material is obtained during 

a single driving cycle, the FTP may be 

repeated as required and the extracted 

organic fractions combined. 

Many of the in vivo biological tests 

proposed in today's notice would 

require six weeks exposures of 

laboratory animals to whole combustion 

emissions for a minimum of six to eight 

hours per day. The continuous 

generation of emissions throughout the 

required exposure periods requires lightduty vehicles to be driven through 

repeated Urban Dynamometer Driving 

Schedule (UDDS) driving cycles and 

heavy-duty engines to be operated over 

repeated Engine Dynamometer Schedule 

(EDS) cycles (40 CFR part 86, appendix 

I), with emissions diluted and routed 

directly from the vehicle to the 

biological testing chamber. Provisions in 

the proposed regulations allow for a 

limited amount of emission generation 

disruption without voiding the biological 

test. 

The use of automated systems may 

provide a means to reduce the 

difficulties associated with continuous 

emission generation. Automated 

systems would involve computerized 

mechanisms used to drive the vehicle on 

a chassis dynamometer or an engine on 

an engine dynamometer. These systems 

could be used in place of human 

operators to perform the monotonous 

task of performing repeated driving 

cycles. Throttle actuators linked to a 

computer system along with electric 

chassis dynamometers could be 

programmed to drive vehicles over 

driving cycles. Such systems have been 

used in the past for mileage 

accumulation purposes and for 

assembly line vehicle testing. However, 

their appUcation is limited to vehicles 

equipped with automatic transmissions. 

Robotic drivers are fairly recent 

options for automated vehicle operation, 

and are expected to provide high 

repeatability and versatility. The 

technology for these systems has been 

developed for related applications, but 

has not been widely used thus far. 

A third possibility for automation 

would involve the use of an isolated 

engine (in conjunction, perhaps, with the 

vehicle's fuel and emission control 

systems) attached to an engine 

dynamometer. Since the input 

parameters required for controlling 

engine dynamometers are different from 

the wheel speed driving trace of the 

chassis dynamometer, the light-duty 

Urban Dynamometer Driving Cycle 

would need to be translated to an 

equivalent load-speed pattern, or else an 

alternate driving cycle would be 

required. 

EPA is initially proposing to require 

the use of engine dynamometers to 

generate emissions for the heavy-duty 

class and chassis dynamometers to 

generate emissions from light-duty 

vehicles. In the heavy-duty case, use of 

an engine dynamometer for emission 

generation is consistent with all existing 

heavy duty emission testing programs 

and also provides considerable cost 

advantages. In contrast, in the light-duty 

case, existing emission testing programs 

require the use of a vehicle operated on 

a chassis dynamometer for emission 

generation. To use an engine 

dynamometer for this purpose, extensive 

testing would have to be done to 

demonstrate that the exhaust emissions 

were the same as those generated from 

the corresponding light-duty vehicle 

operated on a chassis dynamometer. 

Many technical problems would have to 

be confronted in attempting to isolate 

the engine and emission control 

equipment from the vehicle while 

assuring thaf the representativeness of 

the emissions would be maintained. 

These would include decisions, on which 

vehicle systems must remain attached to 

the engine and what methods to use to 

terminate unnecessary systems; the 

addition of a flywheel, harmonic 

balancer, and bell housing to balance 

the system for vehicles equipped with 

automatic transmissions; determination 

of the effect of detaching transmission 

sensors such as gear sensors, clutch 

lock/unlock sensors, and torque 

coverter speed sensors; and the 

translation of the LA-4 chassis 

dynamometer driving cycle to an 

operating cycle appropriate for use with 

an engine dynamometer. 

EPA believes that the putative cost 

savings associated with the use of a 

light-duty engine dynamometer rather 

than a light-duty vehicle and chassis 

dynamometer would be overridden by 

the costs associated with resolving these 

problems and performing tests tp prove 

that the solutions were yatid. However, 

EPA is open to comment on the relative 

costs and benefits of the light-duty 

chassis dynamometer vs. engine 

dynamometer, and would consider 

making the use of the engine 

dynamometer optional in this program if 

the comments provide persuasive 

evidence that this option would be 

advantageous. 

C. Evaporative Emission Generation 

As discussed above the section III.C, 

the evaporative, emissions of some fuels 

and additives will be required to 

undergo emission characterization and 

biological testing. The composition of 

evaporative emissions does not, in 

general, resemble fully-evaporated 

whole samples of raw fuels or fuel 

additives due to differences in vapor 

pressure of the fuel or additive 

components and the effects of 

evaporative emission control equipment. 

The largest sources of evaporative 

emissions from vehicles are diurnal, hot 

soak, and running loss emissions. For 

the purpose of this rulemaking, refueling 

emissions are also-regarded as 

evaporative emissions due to their 

generally similar composition. While the 

most technically accurate method of 

testing these emissions would be to 

characterize and perform biological 

tests on each evaporative source 

separately, such a plan would multiply 

the cosfs involved. The proposed 

evaporative emission characterization 

requires call for the speciation of 

emissions from aU types of evaporative 

emissions measured in the FTP effective 

at the time the testing is done. EPA asks 

for comments on which types of 

evaporative emissions should be 

speciated and if the program should be 

expanded fo include running losses and 

refueling emissions. 

EPA is also proposing that 

evaporative emissions be generated 

without using key components of 

evaporative emission control systems, 

such as the carbon adsorption canister. 

An intact control system would 

represent normal system design, and 

removal of the canister would change 

the relative concentrations of the 

evaporative emission products. On the 

other hand, disconnecting the 

evaporative emission control system 

would provide the opportunity to 

examine emissions simulating 

uncontrolled emission sources such as 

refueling operations and leaky 

evaporative emission control systems. 

Furthermore, as discussed below, use of 

emission control may not be practical 

for evaporative emission generation for 

biological testing purposes. If the 

emission characterization procedures 

are to be performed on emissions that 

closely resemble those used for 

biological testing, it may thus be 

necessary to disconnect the emission 

control system when generating 

emissions for speciation purposes, as 

well. 

Three simplified procedures are being 

considered for continuously generating 

evaporative emissions for in vivo 

biological testing. The first would 

require that' evaporative emission 

generation be performed by using a 
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13196 Federal Register / Vol. S7, No. 73 I Wednesday, April 15, 1992 / Proposed Rules 

sealed housing for evaporative 

determination (SHED3. Tiie diurnal heat 

build section of the FTP would be 

performed, and samples of tiie vapors in 

the SHED would be withdrawn into 

Tedlar bags and used for testing. 

Chemical artifacts caused by storage of 

evaporative emissions are expected to 

be much less of a problem than for 

combustion emissions. For this purpose, 

the SHED would need to be equipped 

with a sampling port and sampling 

pump. To avoid modification of the 

sample, a pump with low hydrocarbon 

absorption and emission characteristics 

(e.g., a teflon diaphragm pump) would 

be required. Generating evaporative 

emissions without any of tiie key 

emission control system components in 

place would help increase the 

concentration of evaporative emissions 

in the SHED in order to produce a 

sample useful for biological testing. 

However, the concentration of 

evaporative emissions in the SHED 

might still be too low to be useful for 

biological testing purposes, even if die 

evaporative emission canister were 

disconnected. 

Another alternative would use 

evaporative emission speciation data to 

make a surrogate mixture of adequate 

concentration for biological testing. 

While this method might seem to have 

some practical advantages, it would rely 

heavily on the speciation data as a 

complete and accurate representation of 

in-use evaporative emissions. 

The third method for generating 

evaporative emissions would be an . 

evaporative emission generation 

chamber instead of a vehicle. The 

chamber would be temperature and 

pressure controlled so tiiat ite 

characteristics were similar to the head 

space of tiie fuel tank of a vehicle where 

in-use diurnal and refueling emissions 

are generated. The chamber would be 40 

percent filled with tiie fuel or additive/ 

base fuel mixture, and the remainder 

filled with air. The system would be 

heated to a prescribed level and the fuel 

or additive mixture allowed to 

evaporate. When equilibrium was 

reached between tiie fuel in tiie liquid 

and vapor states, the vapor and air 

mixture would be withdrawn for 

dilution and testing. The fuel or 

additive/base fuel mixture would need 

to be renewed periodically to keep tiie 

emissions of constant character. 

An extension of tins concept would 

involve the construction of a bench 

apparatus using a duplicate of the fuel 

tank of die vehicle involved together 

with heating elements. Vapors could 

then be drawn directiy from the head 

space of the fuel tank. However, this 

method might create safety concerns 

concerning the heating of the sample to 

cause evaporation. One option would be 

to reduce the air pressure over the fuel 

or additive/base fuel mixture to induce 

evaporation. 

In comparison with the SHED-based 

system, the bench method has tiie 

advantage of requiring much smaller, 

less expensive, and simpler equipment 

Emissions could be generated close to 

the biological testing chambers, and 

largely automated systems could be 

used. Another advantage is that the 

concentration of emissions which occurs 

in the biological test chamber could be 

controlled to a much greater extent with 

bench methods than with the SHED 

method, in which air dilution is fixed by 

the size of the SHED and the specific 

vehicle generating the emissions. The 

surrogate emission generation method 

has the drawback of relying too heavily 

on the speciation data for its accuracy. 

For these reasons EPA proposes to 

require the use of a bench method (i.e.. 

evaporation chambers) for generating 

emissions for in vivo biological testing. 

Comments are requested on this issue. 

EPA proposes that evaporative 

emission control equipment not be used 

on the emissions generated by the 

evaporation chamber. As stated above, 

this would enable the testing of 

emissions which represent uncontrolled 

emission sources such as refueling 

operations. In addition, removal of the 

emission control canister would allow 

the generation of more concentrated 

emissions, which are required for the 

biological tests specified under Tier 2 of 

this program. A third reason is the , 

complexity of the procedures which 

would be required for canister loading 

and purging cycles if the emissions from 

the evaporation chamber were to 

resemble in-use vehicle evaporative 

emissions. EPA requests comment on 

this question of the proper use of 

evaporative emission control systems 

for biological testing purposes. 

EPA is aware that the methods 

proposed are different for combustion 

and evaporative emissions with respect 

to the role of emission control 

equipment This inconsistency arises 

from practical considerations. First; in 

the case of combustion emission controL 

many different vehicle components are 

involved. While some of these 

components could possibly be removed 

or disabled to simulate emission control 

malfunction, others are integral to 

proper running of the engine and their 

removal would cause the vehicle to be 

inoperable. Therefore, generating totally 

uncontrolled combustion emissions 

would not be a reasonable option. 

Secondly, the types of combustion 

emission control equipment and each 

component's individual effects on 

emissions varies greatly from vehicle to 

vehicle, making it extremely difficult to 

devise, a reasonable basis for 

determining which components could • 

selectively be disabled. Thus, all 

combustion emissions control 

components are proposed to be 

maintained m the proper functioning 

condition during combustion emission 

generation for this program. 

Conversely, at the present time, tiie 

primary (vehicle-based) source of 

evaporative emission control is the 

evaporative emission canister. This 

device does not affect a vehicle's 

bperability. In order to obtain 

evaporative emission samples of 

sufficient concentration for biological 

tests, and to represent uncontrolled 

emissions sources, EPA has proposed 

that evaporative emission control 

equipment be disconnected for 

evaporative emission generation. 

Comments are requested on whether a 

consistent use of emission control 

equipment for combustion and 

evaporative emissions is important for 

this program, and if so. How the program 

should be restructured to accomplish 

this end. If the program were 

restructured, EPA specifically asks for 

comment on the desirability of using a 

controlled evaporative system for 

emission characterization purposes and . 

an uncontrolled system for biological 

testing. 

D. Additional Emission Generation 

Topics 

1. Emissions for Atypical Elements 

The "atypical" elements described in 

section IV (generally, those other than 

carbon, hydrogen, oxygen, nitrogen, and 

a limited amount of sulfur) may form 

particulate combustion products which 

can deposit on the Inside of the-vehicle's 

engine or emission control system. 

Deposition of the atypical elements 

inside the vehicle may be particularly 

significant when the fiiel or fuel additive 

is first introduced, thus interfering with 

identification and accurate 

measurement of the atypical species. As 

the internal deposits increase, it is 

expected that a greater fraction will be 

emitted into the atmosphere until the net 

deposition inside the vehicle/engine is 

small. 

As is discussed further in section 

VI.A.2.f below, additional requirements 

are thus proposed for "atypical" fuels 

and additives to ensure that the atypical 

elements are fully represented in the 

sampled emissions. After die minimum 
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Federal Register / Vol. 57. No. 73 / Wednesday. April 15. 1992 / Proposed Rules 13197 

25.000 miles have been accumulated, 

emissions wiU be coUected from the 

vehicle and subjected to preliminary 

analysis, including the standard 

characterization required for all fuel and 

additive formulations and those which 

measure the presence of atypical 

elements in exhaust and, if applicable, 

evaporative emissions. Then, 

measurements will be made to . 

determine whether a steady state has 

been reached between the rate of entry 

and emission of the atypical elements. If 

not, additional mileage accumulation 

will be performed until the emissions of 

the atypical elements reach steady state. 

Steady state will be defined as the point 

at which the mass of the atypical 

elements emitted during the 

performance of one or more Urban 

Dynamometer Driving Schedules/Engine 

Dynamometer Schedules is within 10 

percent of the mass of the atypical 

elements that entered the combustion 

chamber during the driving cycles. 

In determining whether steady state 

has been reached, some less obvious 

pathways for the loss or introduction of 

the atypical elements may need to be 

taken into account. For example, if the 

atypical compounds could be lost 

through evaporation, then the 

evaporative emissions would be 

speciated for these compounds. If the 

atypical element enters the motor oil via 

the combustion chamber, the 

concentration of the atypical element in 

the motor oil may be measured and 

entered into the mass balance. If there is 

reason to suspect that the air used 

during combustion or dilution may 

contain significant quantities of the 

atypical element under evaluation, this 

air must also be tested and the problem 

rectified. 

EPA is initiaUy proposing that mileage 

accumulation be continued either until 

steady state of the atypical elements has 

been reached or until the vehicle or 

engine has been operated on (he 

atypical fuel or additive for the 

equivalent of 80 percent of its estimated 

useful life (e.g., 60,000 miles for lightduty vehicles). The purpose of this 

rigorous requirement is to ensure that 

the emission products of the elements of 

concern are known and that their 

concentrations are stable when the 

emissions are used in subsequent 

testing. In actual use, however, few 

vehicles are likely to be driven 

continuously on "atypical" fuels and 

additives. The use of such products by 

consumers is more likely to be , 

intermittent and/or limited to particular 

owners along the chain of individuals 

who may own a given vehicle. Thus, the 

proposed requirement for accumulating 

mileage up to 60 percent of a vehicle's or 

engine's useful life (unless steady state 

is reached af an earUer point) may far 

exceed the amount of mileage and the 

concentration of atypical emission 

products which would generaUy be 

encountered in actual use. If so, a lower 

mileage requirement perhaps in the 

range of 25-50 percent of the vehicle's 

useful Ufe, may be more appropriate in 

pursuit of the steady state condition. 

Comments are requested on these issues 

and on appropriate mileage 

accumulation requirements. Data on 

typical consumer usage patterns for 

atypical products would be particularly 

helpful fo this decision. If the comments 

are supportive of a change in the 

proposed requirements, EPA would 

expect to reduce the mileage 

accumulation required in the Final Rule 

for atypical fuels and additives to a 

mileage figure in the lower range 

mentioned above. 

2. Verification Testing 

A number of mechanisms can cause 

emissions fo.be captured in the dilution 

and sampling system before they can be 

characterized or used for animal 

exposures. The ratio of emissions that 

exit the sampling system to those that 

enter is called the "recovery factor" of 

the system. The recovery factor must be 

high in order for subsequent emission 

testing fo be meaningful. Determination 

of the recovery factor is called 

verification testing. 

Verification testing is required in the 

FTP using propane or carbon monoxide 

for gasoline and diesel fuels and using 

methanol for methanol-containing fuels. 

It is accomplished by injecting a known 

sample into the dilution system at the 

end of the exhaust pipe and measuring 

the amount that exits the sample probe. 

While the performance of this standard 

verification testing will determine if the 

system is leaking, recovery of these 

compounds does not necessarily imply 

the recovery of all of the different 

compounds subject fo the speciation . 

procedures of this program or all 

biologically significant emission . 

products. EPA asks for comment on 

whether further verification testing 

should be required for this program 

using additional compounds. 

In order for the system to be 

acceptable, a minimum recovery rate 

would be required for each compound in 

an injected sample composed of known 

chemicals of the type under analysis. 

Such verification procedures would be 

relatively easy to perform when 

emissions are being generated for 

characterization purposes, since 

calibration compounds and speciation 

equipment would be readily available. 

However, when emissions are being 

generated for purposes of biological 

testing, simplified verification testing 

may be in order, since biological testing 

laboratories may not always have 

sophisticated speciation apparatus 

available. In this case, an injected 

hydrocarbon sample could be detected 

with a gas chromatograph and flame 

ionization detector to estimate the 

recovery factor. EPA asks for comment 

on these proposed requirements for 

verification testing. 

3. Emission Storage and Transport 

As mentioned previously, emissions 

can be stored for only a Umited period 

of time before chemical changes may 

occur, lhe. critical time period is a 

function of the composition of the 

emissions, the temperature and pressure 

under which they are contained, the 

vessel in which they are stored, the 

amount of sunlight fo which they are 

exposed, and the amount of 

deterioration that is considered 

acceptable. The maximum allowable 

storage times for emissions which are to 

be subjected to chemical analysis will 

vary depending on the speciation 

protocol, and are identified in relevant 

parts of the proposed regulatory text. 

Storage time is not an issue in regard 

to biological tests using whole 

combustion or evaporative emissions. . 

since these emissions are fo be 

generated continuously. Particulate 

phase emissions can be stored up to six 

months, either on the coUection filter or 

after extraction, Hie stored material 

must be sealed in a container that is 

opaque to ultraviolet light and 

maintained at — ZOO C or less. Semivolatile phase emissions must be 

extracted immediately after collection, 

stored af —200 C and used within six 

months. Special emission handling 

specifications for biological testing 

purposes are considered in section VI.C. . 

Comments on these storage and 

handling specifications would be 

welcome. 

4. Emission Generation Facilities for 

Biological Testing 

While the continuous generation of 

combustion emissions appears to be an 

essential component of the proposed in 

vivo biological test requirements, EPA is 

unaware of any commercial biological 

laboratories which offer such services at 

the current time. Installation of the 

necessary vehicle-related equipment by 

biological laboratories would require 

significant capital expenditure and 

considerable time for start-up and 

training. Similar problems would arise if 

vehicle testing labs were fo install 
P.33 

13198 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

biological exposure chambers adequate 

for the proposed program. EPA asks for 

comment on the ways in which 

adequate facilities for the biological 

testing required by this program can be 

made available to the fuel/additive 

producers seeking registration, either 

through increased facility availability or 

simplified testing requirements. EPA 

also asks for comments and suggestions 

on what remedies are available under 

the Act if adequate facilities have not 

become available when testing is to be 

conducted. 

E. Special Requirements for Additives 

1. Base Fuel Specifications 

As discussed in Section III, fuel 

additives subject to testing are to be 

mixed with the designated base fuel 

formulation for their respective fuel 

family prior to the generation of 

emissions. The base fuel formulations 

are also proposed to serve as the 

representatives for groups in the 

baseline fuel/additive categories. To 

define appropriate base fuel 

formulations for the gasoline, diesel, and 

methanol fuel families, EPA proposes to 

establish specifications based on the 

national annual average of fuel sales. 

For this purpose, EPA plans to adopt the 

method proposed in the reformulated 

gasoline rulemaking (56 FR 31176), 

which uses sales-weighted averages of 

fuel survey data to determine national 

average parameters for wintertime 

unleaded gasoline. The averaging 

procedure wiU be based at least in part 

on Motor Vehicle Manufacturers 

Association (MVMA) fuel survey data. 

In the near future, "alternative" fuels 

are expected to generate demand for a 

variety of new bulk and aftermarket fuel 

additives. At the present time, however, 

base formulations for these alternative 

fuel families wiU not be defined. When 

the time comes that a fuel additive to an 

alternative fuel requires a base fuel for 

testing purposes, an industry average of 

important parameters in existing fuels 

wiU be determined and the base fuel 

specification defined. 

Fuel additives wtil need to be added 

to the "average" fuels determined by the 

survey in order for these fuels to be used 

in motor vehicles. Examples of . 

necessary fuel additives may be 

stabilizers, deposit control additives, 

and corrosion inhibitors. Only additives 

determined to be necessary for proper 

fuel and vehicle functioning will be 

components of the base fuels. These 

additives, along with their in-use 

concentrations, wiU be determined by 

EPA with input from interested 

industries and groups. 

A memorandum entitled, "Base Fuel 

Determination Procedures for the 

Proposed Fuels and Fuel Additives 

Rulemaking," is available in the public 

docket. This memorandum illustrates 

the proposed approach for specifying 

base fuel formulations and presents 

sample values for base gasoline and 

diesel fuels. It also discusses such issues 

as base fuel blending tolerances and the 

need for a standard set of base fuel 

additives. 

2. Additive and Base Fuel Emissions 

Comparison 

Emissions from fuel additives may, in 

some cases, be difficult to distinguish 

from the emissions of the base fuel 

itself. Ideally, the emissions contributed 

by an additive would be determined by 

performing tests on two identical 

vehicles, one fueled with the base fuel 

alone and the other fueled with the 

additive/base fuel mixture. Test results 

on the emissions from the two vehicles 

would be compared and the difference 

attributed to the fuel additive. However, 

significant variability can exist between 

vehicles even of the same year and 

model. Furthermore, the additional 

expenditure for conducting tests on two 

vehicles, one with and one without the 

fuel additive, would be considerable. 

Nonetheless, from a scientific 

perspective, side-by-side testing would 

be the preferred approach. 

An alternative to this method is 

proposed, in which only one vehicle 

model would generate and test the base 

fuel emissions for each fuel family, with 

the results made available for use as 

control data for aU additives in the fuel 

family. Standardization of the vehicle 

make, model, and year would be an 

important requirement Under this 

approach, base fuel testing would be 

done as part of the program 

automatically, since the group 

representative for each baseline group is 

also a base fuel for the respective fuel 

family. Thus, no additional effort would 

be required on the part of the additive 

producers in order to perform the 

comparison analysis. This method could 

provide a reasonable set of control data 

for comparison against the test results . 

for fuel additives (both emission 

characterization and biological studies), 

at a fraction of the cost of the more 

rigorous approach. However, the 

requirement that the same vehicle make, 

model, and model year be used for 

testing the base fuel and the additive/ 

base fuel mixture would become 

problematic for fuel additives tested 

some years after the base fuel was 

tested, since acquiring a new (unused) 

vehicle of a previous model year would 

be difficult. EPA asks for suggestions as 

to how this requirement can be 

effectively implemented. Of course, any 

additive producer could conduct 

independent base fuel testing in lieu of 

relying on the results of the group 

responsible for base fuel testing. 

In case the baseline group(s) in some 

fuel families are able to satisfy the Tier 

1 and Tier 2 requirements based on 

existing testing, EPA asks for comment 

on how various additive producers 

needing base fuel information could 

work cooperatively for these purposes. 

EPA also requests comment on the 

appropriateness of this proposed 

method for distinguishing the emissions 

effects of fuel additives from the 

emission effects of the base fuel. 

Section VA presented another 

alternative for comment, in which six 

vehicles would be used to generate 

emissions both for the additive/base 

fuel mixtures being tested and for the 

applicable base fuel. While this 

approach would reduce the problem of 

vehicle-to-vehicle emissions variability, 

it depends on the vaUdity of the 

assumption that carryover effects from 

fuels and additives used previously in 

tiie vehicles would be negligible. To the 

degree that this assumption is valid, the 

use of the same vehicles to generate 

emissions for comparison might be 

preferred. 

3. Additive Concentration 

Prior to emission generation and 

testing, additives are to be mixed with 

their associated base fuel to a 

concentration equal to that 

recommended by the additive producer 

as the maximum in-use concentration. 

One alternative would require mixing of 

fuel additives in their base fuels at a. 

significantly higher concentration than 

the recommended amount, i.e., to "dope" 

the mixture with the fuel additive. 

Another possible method of doping an 

additive/base fuel mixture would be to 

significantly increase the concentration 

of particular components of an additive 

product (e.g., the compounds that 

contain atypical elements). The primary 

purpose of these approaches would be 

to enhance the contribution of the "*-

additive product (or the particular 

component of concern) to the emissions 

produced by the additive/base fuel 

mixture. This would facilitate the task of 

detecting and analyzing the additive's 

emissions and distinguishing them from 

the emissions produced by the base fuel. 

It would also effectively increase the 

dosage of additive emissions during 

biological exposures to additive/base 

fuel emissions, increasing the likelihood 

that observable changes could be 

detected in comparison with exposures 
Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13199 

to emissions of the base fuel alone. EPA 

asks for comment on the mixing rules 

that should be adopted and on the 

validity of doping the base fuel with the 

fuel additive or active ingredient. 

Comment is also requested on 

appropriate additive concentration 

levels, if a doping procedure were to be 

adopted for the final rule. 

VI. Evaluation of Health and Welfare 

Effects 

The scope and general structure of 

proposed provisions for evaluating the 

potential health and welfare effects of 

fuels and fuel additives were discussed 

above in sections III.E and F. The 

program focuses on the contribution of 

fuels and additives to harmful air 

pollution, and includes requirements to 

determine the composition and potential 

effects of fuel/additive emissions 

generated by both combustion and 

evaporative processes. Health effects 

testing provisions are specifically 

focused on the effects of inhalation 

exposure to fuel/additive emissions in 

regard to the following selected 

endpoints: carcinogenicity, 

mutagenicity, developmental effects, 

reproductive effects, pulmonary toxicity, 

and neurotoxicity. The impacts of fuel 

and additive emissions on the public 

welfare and the environment are 

addressed by data research 

methodologies. 

As previously described, the required 

evaluation procedures are organized 

within three successive tiers. AU fuels 

and additives (or fuel/additive groups) 

must be evaluated in compliance with 

the first two tiers. Tier 1 includes 

requirements for the characterization of 

fuel or additive emissions, the 

compilation of existing information on 

the potential adverse effects of the 

emissions, and the modeling of 

exposure, reactivity, and environmental 

partitioning. Tier 2 is comprised of shortterm biological screening tests for the 

specified endpoints. Both the Tier 1 

emission characterization and the Tier 2 

biological testing requirements may be 

mitigated by the demonstration of 

adequate existing testing. The 

information from these two tiers, 

together with other available toxicity 

and exposure data, will be assessed by 

EPA to determine when further study is 

needed to provide adequate information 

for regulatory decision-making. In that 

instance, additional testing requirements 

will be imposed under the provisions of 

Tier 3. 

The specific requirements of each 

health/welfare evaluation tier are 

described in more detail in the following 

sections. 

A. Tier 1: Characterization of Emissions 

1. Scope of Characterization 

Requirements 

The proposed requirements for 

emission characterization are intended 

to satisfy the provisions in Section 211 

to "determine the emissions" of fuels 

and additives, and to provide a partial 

inventory of potentially harmful 

emission products for further study and 

evaluation in support of programs such 

as the Mobile Source Related Air Toxic 

Program (section 202(1)(1) of the Clean 

Air Act). In general, the required 

procedures are directed toward the 

detection and measurement of selected 

chemical classes and compounds. A 

complete and precise characterization of 

all emission products would require test 

protocols specific to all possible 

compounds, a nearly impossible task. 

For this reason, the proposed program 

focuses on measurement of regulated 

emissions and on the identification of 

specified classes of compounds of 

interest. 

For most fuels and fuel additives, 

proposed emissions analysis 

requirements are limited to the 

determination of the emission rate of 

regulated emissions and the speciation 

of volatile hydrocarbons, aldehydes, 

ketones, ethers, alcohols, polycyclic 

aromatic hydrocarbons (PAH), (the 

subset of polycycUc organic material 

[POM] that includes only hydrocarbons) 

and nitrated polycyclic aromatic 

hydrocarbons (NPAH). These 

requirements are summarized in Figure 

4. For fuels and additives that contain 

"atypical" elements (as defined in 

section IV), the chemical fate of the 

atypical components must be 

determined. Comments are solicited on 

the adequacy of these proposed areas of 

analysis for characterizing tiie emissions 

of fuels and fuel additives. 

Comments are specifically requested 

on whether speciation of nitrogencontaining emissions should be included 

as a requirement for fuels and additives 

which contain appreciable quantities of 

this element Such information might be 

of value in determining the chemical 

basis for toxic effects which might be 

observed during in vivo biological 

testing. 

FIGURE 4.-EMISSION CHARACTERIZATION REQUIREMENTS 

Emission type RE HC Ket and 

Aid 

Ale and 

Eth PAH NPAH 

Combustion emissions: 

Vapor phase emissions 

Semi-volatile phase emissions.. 

Particulate phase emissions 

Evaporative emissions: * 

Diurnal emissions 

Hot soak emissions 

X-« 

X

1 

X ' 

1

 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 and Ket=aldehydes and 

ketones Ale & Eth=alcohols and ethers, PAH=polycyclic aromatic hydrocarbons. NPAH=nitrated polycyclic aromatic hydrocarbons. 

As proposed in section V, the 

generation of both combustion and 

evaporative emissions would generally 

involve equipment and procedures 

normally applicable to the certification 

of new vehicles. Three bags of vapor 

phase and three filters of particulate 

phase combustion emissions would be 

collected for each light-duty vehicle. For 

heavy-duty vehicles, one bag and one 

filter of combustion emissions would be 

collected during the cold start and one 

bag and one filter during the hot start 

segments of the transient test cycle. For 

fuels and additives subject to 

evaporative emission requirements, one 

bag of diurnal emissions and one bag of 

hot soak emissions would be collected 

from the SHED. 

Unless otherwise noted, each 

speciation protocol is to be performed 

on each sample of combustion 

emissions. Speciation requirements for 

evaporative emissions are limited to the 

analysis of hydrocarbons, ethers, and 

alcohols (if the latter are present in the 

fuel/additive formulation). To provide 

an indication of the variability of 

emissions, EPA proposes that the entire 
P.35 

13200 Federal Register / Vol. 57. Np. 73 / Wednesday, April 15, 1992 / Proposed Rules 

emission generation and 

characterization process be performed 

three times. 

CoUection and speciation of 

background samples is not required. 

However, if background samples are not 

speciated, the emissions that are 

measured in the speciation protocols 

will be assumed to be entirely due to the 

fuel or additive of interest. 

2. Emission Characterization Protocols 

The Clean Air Act authorizes EPA to 

require information to characterize fuel/ 

additive emissions, while giving EPA 

discretion to specify the particular 

protocols which must be used for this 

purpose. Thus, the foUowing sections 

identify the general emission product 

categories of Interest and discuss 

Currently available protocols which are 

suitable for these purposes. However, 

scientific methods can be expected to 

advance in the next few years, and the 

use of these protocols is not mandated. 

Rather, EPA wiU hold producers 

accountable for state-of-the-art methods 

and good analytical chemistry and 

laboratory practices. These practices are 

described in the article "Principle of 

Environmental Analysis", found in The 

Journal of Analytical Chemistry, 1983, 

Volume 55. The regulated emissions 

need to be measured by EPA approved 

methods. Current methods are described 

in 40 CFR 88; however, if Uiese methods 

are revised or new compounds 

regulated, then methods in force at the 

time the regulated emissions testing is 

performed are the methods that must be 

used for this program. 

a. Characterization of regulated 

emissions. The term "regulated 

emissions" for this program refers to 

emission products for which standards 

have been established for the purpose of 

the certification of new motor vehicles 

(40 CFR part 86). Vehicles of three fuel 

families (gasoline, diesel, and methanol) 

are presently required to undergo 

certification testing. The regulated 

emissions applicable to each family are 

shown in Figure 5. Oxides of nitrogen 

and carbon monoxide are regulated 

combustion emissions common to all 

three fuel families. Organic material is 

regulated in various forms depending on 

the vehicle and fuel type. Particulate 

emissions, already regulated for diesel 

cycle vehicles, will be regulated for 

light-duty Otto cycle vehicles beginning 

in 1994. Methanol-fueled vehicles are 

tested for methanol and formaldehyde 

as part of the organic material 

standards. Evaporative emissions from 

otto cycle vehicles and methanol-fueled 

vehicles are regulated for organic 

material, including methanol 

measurement when relevant. 

FIGURE 5.—REGULATED EMISSIONS 

Fuel cycle 

Gasoline/Otto 

Methanol/Otto _ 

Methanol/Diesel 

Combustion emissions 

Total HC 

1 

1 

NMHC 

2 

2 

OMHCE 

1 

1 

OMNMHCE 

2 

2 

NOx 

' 1 

1 

1 

1 

CO 

1 

1 

1 

1 

PM 

2 

2 

1 

1 

Evaporative 

Emissions -

Total HC 

1 

OMHCE 

1 

1 

Notes: 

1= Always. . 

2=After 1994 for light-duty vehicles/trucks only. 

Total HC=Total Hydrocarbons. 

NMHC=Non-Methane Hydrocarbon. 

OMHCE=Organic Material Hydrocarbon Equivalent (includes tests for HC, methanol, and formaldehyde). 

OMNMHCE=Non-Methane OMHCE. 

NOx=Oxides of Nitrogen. 

CO=Carbon Monoxide. 

PM=Particulate Matter. 

. The regulated emissions are to be 

measured for fuel/additive registration 

purposes in the same manner and with 

the same degree of accuracy as 

specified in 40 CFR part 88 for vehicle 

certification, including evaporative 

emissions and combustion emissions of 

both vaporous and particulate phases. 

Only those regulated emissions included 

in the certification requirements for the 

vehicle type and model year used to 

generate.emissions for testing (selected 

according to the criteria in section V A) 

need to be determined for this program. 

The results of these tests are to be 

reported in the manner specified for 

vehicle certification. Comments are 

requested on these requirements. 

b. Hydrocarbon characterization. 

Speciation of hydrocarbons in the vapor 

phase of emissions is to be performed 

using methods that identity and 

determine the concentration of all 

hydrocarbon compounds containing 

twelve or fewer carbon atoms. An 

acceptable speciation method, available 

in docket A-90-07, is described in the 

document "Research Protocol Method 

for Analysis of Detailed Hydrocarbons 

Emitted from Automobiles by Cas 

Chromatograph" (June, 1991). The 

procedure is to be performed on both 

combustion and evaporative emissions. 

Hydrocarbon compounds of higher 

molecular weight (i.e., more than twelve 

carbon atoms) tend to condense and/or 

adsorb onto particulate surfaces at 

dilute exhaust temperatures and 

concentrations and are therefore not 

amenable to this type of analysis. EPA 

asks for comment on possible 

requirements for identifying 

chromatographic peaks using mass 

spectroscopy when peak identity is 

questionable and when coelution is 

suspected. 

c. Aldehyde and ketone 

characterization. Speciation of 

aldehydes and ketones is required only 

for the vapor phase of combustion 

emissions, collected using the equipment 

and methods prescribed in 40 CFR part 

86 for formaldehyde measurement. A 

currentiy available procedure which can 

accurately analyze aldehydes and. 

ketones is the ASTM D5197-91, 

"Standard Test Method for 

Determination of Formaldehyde and 

Other Carbonyl Compounds in Air 

(Active Sampler Methodology)". The 

speciation procedure involves the 

reaction of aldehydes with 2,4-

dinitrophenylhydrazine to form stable 

derivatives that are analyzed by high 

performance liquid chromatography 

(HPLC) using an ultraviolet light 

detector. 

d. Alcohol and ether characterization. 

Alcohols and ethers are to be analyzed 

in combustion and evaporative 

emissions whenever the fuel or additive 

under evaluation or the base fuel mixed 

with the additive contains alcohols or 

ethers. The emissions are to be collected 

and analyzed using the procedures 
Federal Kegister /Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13201 

• - •' - » .'' — • 

prescribed in 40 CFR part 80, appendix 

F, entitled 'Test Method for 

Determination of C1-C4 Alcohols and 

MTBE in Gasoline by Gas 

Chromatography". Tliis procedure can 

be used for the identification of ethers in 

addition fo MTBE, but will require 

appropriate modifications for 

application fo gas phase samples. 

e. PAH and NPAH characterization. 

PAH and NPAH are mutagenic 

compounds which have been designated 

as a topic for study by the Clean Air Act 

(section 202(1)(1)) fo determine if their 

emission by motor vehicles should be 

regulated. PAH and NPAH are typically 

found in combustion emissions, and 

their identification in evaporative 

emissions will not be required under 

Tier 1 provisions. In the past PAH and 

NPAH have been analyzed primarily in 

the particulate phase. However, 

evidence now suggests thaf the quantity 

of these compounds in the semi-volatile 

phase af the temperatures encountered 

in dilute exhaust may be important. For 

this reason, PAH and NPAH will be 

speciated in both semi-volatile and 

particulate phase emissions. 

At this time, EPA is proposing that 

these PAH and NPAH characterization 

requirements be appUed to aU organicbased fuels and additives. However, it 

has been argued that the combustion of 

low molecular weight fuels such as 

methane, propane, ethanol, and 

methanol will not generate PAH and 

NPAH in significant quantities if the 

vehicles that generate the emissions are 

In proper operating condition. 

Comments and supporting data are thus 

requested on the necessity of imposing 

PAH and NPAH characterization 

requirements for these fuels. 

Particulate and semi-volatile phase 

emissions are fo be collected as 

specified in section V.B. The soluble 

organic fraction (SOF) is fo be extracted 

from the filter and polymer bed 

separately and used in separate testing 

procedures. Protocols suitable for 

characterizing PAH and NPAH have 

been published by the Coordinating 

Research Council4 Both methods 1 and 2 

described for PAH speciation in this 

reference are acceptable, but the 

alternate method given for the detection 

of NPAH is not EPA requests comments 

and suggestions regarding these 

proposed procedures. 

f. Characterization of emissions with 

atypical elements. As discussed in 

section IV, fuels and fuel additives 

which contain chemical elements other 

s

 CRC Report No. 551 (1987) Chemical Methods 

for the Measurement of Unregulated Diesel 

Emissions. Coordinating Research Council, Inc. 219 

Perimeter Center Parkway, Atlanta, CA 30346. 

than those included in the base fuel 

formulation for their respective fuel 

family are classified as "atypical" 

formulations. For the most part, atypical 

products are those with elemental 

components other than carbon, 

hydrogen, oxygen, nitrogen, and a 

limited amount of sulfur. Some of the 

atypical elements contained in such 

products are the foUowing: Aluminum, 

Bismuth, Bromine, Cadmium, Cerium, 

Chlorine, Chromium, Cobalt, Copper, 

Fluorine, Iodine, Iron, Manganese, 

Molybdenum, Nickel, Lead, Platinum, 

Selenium, Sulfur (if present In amounts 

exceeding 1,080 ppm in gasoline 

formulations or 0.05 percent in diesel 

formulations), Titanium, Vanadium, 

Zirconium, and Zinc. In addition to the 

emission characterization requirements 

described in subsections a-e above, 

producers of "atypical" fuels and 

additives will be required to identify 

and measure the emission products 

containing the associated atypical 

elements. Because of the variety of 

potential elements and reaction 

products involved, all of the necessary 

chemical analytic procedures cannot be 

specified in this proposal. However, the 

procedures used must be state-of-the-art 

and based on sound analytical 

chemistry principles. 

Generation of the emissions used for 

speciation of the emission products 

containing atypical elements was 

discussed in section V of this notice. To 

summarize briefly, EPA proposes that 

combustion emissions must be in steady 

state prior to sampling, such that 

essentially all (at least 90 percent) of the 

atypical elements entering the 

combustion chamber also exit in the 

vehicle exhaust. Steady state is to be 

determined by a mass balance using 

analytical protocols determined by the 

fuel/additive manufacturer. Mileage 

accumulation driving will be used to 

condition the vehicle until steady state 

is reached. If the atypical element has 

not reached steady after the minimum 

25,000 mile requirement, mileage 

accumulation must continue. The 

producers involved will determine when 

to conduct additional testing fo see 

when steady state has been reached. If 

the emission rate of the atypical 

compounds has not reached steady state 

within 80 percent of the useful Ufe of the 

vehicle or engine, one final emission 

collection will be performed and the 

emissions analyzed for combustion' 

products containing the atypical 

elements. The special Tier 1 emission 

characterization requirements for 

"atypical" fuels and additives will be 

considered complete at this point under 

the assumption that elements not 

emitted during most of the useful life of 

the vehicle probably do not pose a 

significant health threat. 

EPA asks for comments on whether 

the fate of all elements other than 

carbon, hydrogen, oxygen, nitrogen, and 

sulfur should be determined, or whether 

a select group of such elements should 

be subjected to these requirements. 

Also, comments are requested on the 

proposed requirements for determining 

the fate of atypical elements and 

whether initial steady state 

determinations should be allowed prior 

fo 25,000 miles. 

3. Quality Assurance 

The accuracy of a testing program is a 

reflection of the repeatability and 

reproducibility of test results. 

Repeatability is a measure of the 

variation of results when tests are 

repeated on one set of equipment with 

all other variables constant, while 

reproducibility is a measure of the 

variation of results when an experiment 

is performed on different sets of 

equipment with all other variables 

constant. 

This section proposes the adoption of 

some methods fo ensure a high degree of 

accuracy for the emission 

characterization program. 

a. Repeatability. While today's 

proposal suggests that repeatability 

should be determined by replicating 

each test or calibration, the emissions 

from a given vehicle are themselves 

subject to some variation. Thus, 

replicating vehicle-based tests fo 

measure the repeatability of 

experimental equipment and procedures 

might yield misleading results. A more 

controlled approach would entail testing 

a set of known compounds periodicaUy 

to determine the repeatability of test 

procedures. For this purpose, a prepared 

mixture of appropriate chemical 

compounds would be subjected fo the 

protocols prior to testing the actual 

emission sample. These calibration tests 

would also be performed at intervals 

throughout the testing of fuel/additive : 

emissions to assure continual 

satisfactory performance. Such tests are 

commonly used for calibrating 

chromatograph equipment Comments 

are requested concerning the use of this 

or other proposed methods for assuring 

repeatable speciation results, including 

what compounds should be used for 

each procedure. 

b. Reproducibility. Reproducibility is 

sometimes ascertained by implementing 

round robin testing of a given sample by 

a number of laboratories. The results of 

the round robin can determine the ' 

inherent procedural variation along with 
P.37 

13202 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

the quality of the labs performing the 

test. For example, if four labs obtained 

similar results for a known solution and 

one lab produced results that were 

significantly different the 

reproducibility could be evaluated by 

the results of the four similar labs and 

the fifth lab could be excluded from 

further testing until the differences were 

resolved. 

EPA asks for comments on possible 

arrangements for participating labs to 

perform speciation protocols in the 

context of a round robin program in 

order to determine test reproducibility 

and identify those labs capable of 

performing the required protocols with 

sufficent accuracy. To this end, labs 

wishing to take part in the testing 

program could voluntarily test a 

vehicle's emissions or analyze an 

unknown sample provided by EPA If 

the results were accurate, EPA would 

have some assurance that the data 

generated by the lab would be 

acceptable. 

c. Audits. EPA will reserve the right to 

audit testing faciUties involved in the 

generation and characterization of 

emissions for purposes of fuel/additive 

registration so that the quality of results 

is assured. Such audits would be 

organized and administered by EPA at 

its own expense. The audit procedures 

could include a requirement that 

facUities submit a completed 

questionnaire in which equipment and 

procedural information would be 

described. EPA could make 

recommendatioins based on the 

submitted information and follow up 

with a visit to observe the performance 

of the protocols. The audit could also 

include EPA distribution of "blind" 

samples for analysis at participating 

laboratories. The audit would not have 

the purpose of certifying that the 

laboratory is "EPA approved". Ratier, it 

would have the purpose of determining 

the weaknesses of labs and the 

acceptability of the lab's current 

performance. Comments would be 

appreciated on the implementation of 

laboratory auditing practices. 

4. Other Emission Characterization 

Issues 

a. Emissions modeling. The 

Reformulated Gasoline program (56 FR 

31176, July 9,1991) requires the 

extensive use of emissions modeling in 

place of actual speciation procedures to 

determine emission products. These 

models predict the combustion 

emissions from the fuel's composition. 

This approach was adopted because of 

its convenience, cost and expected 

comparable accuracy for purposes of the 

program. 

The "Simple Model" of the 

reformulated gasoline program uses a 

fuel's RVP, oxygen, benzene, and 

aromatic weight percents to predict the 

emission rate of non-methane volatile 

organic compounds, benzene, 1,3-

butadiene, formaldehyde, acetaldehyde, 

and POM. In 1993, other fuel parameters 

will be included in the program's 

"Complex Model". However, these 

models faU far short of the speciation 

requirements proposed for this program. 

For example, benzene and 1,3-butadiene 

are only two of more than 100 

hydrocarabons determined by the 

hydrocarbon speciation protocol 

proposed in section VI.A.2.b. 

Given the differences in the goals and 

requirements of the two programs and a 

general lack of emission data to develop 

broader models, it may not be possible 

to meet the requirements of the present 

rulemaking using emissions modeling. 

This ralemaking involves the 

determination of various emissions from 

a wide variety of fuels and fuel 

additives. Some of the fuel additives 

contain compounds that are not common 

in fuels. Thus, emissions modeling does 

not appear to be adequate for this 

program and is not being proposed as an 

alternative means for determining 

emissions. Until models are capable of 

accurately predicting individual 

chemical species for entire classes of 

compounds, EPA regards emission 

generation and testing to be the only 

viable alternative. Nevertheless, EPA 

requests comment on the possible role 

of emissions modeling for fulfilling the 

emission characterization requirements 

in this proposed rulemaking, especiaUy 

in regard to evaporative emissions, 

which seem somewhat more suited to 

modeling approaches. If use of the 

Simple or Complex Models is supported, 

EPA requests that a full justification be 

provided as to why the model results 

should be deemed to be equivalent to 

the results achieved under this program. 

b. Raw product testing. Under the 

current fuel/additive registration 

program, fuel and fuel additive 

manufacturers are required to detennine 

and report the composition of their 

products. However, few regulations 

have been promulgated governing the 

accuracy of this information and die 

procedures for raw product analysis. 

Particular short coming in the existing 

program are the underreporting of 

impurities which may be present in the 

fuels and fuel additives and the 

relatively broad reporting catgegories/ 

criteria permitted for petroleum fuel 

constituents. With extensive emission 

speciation requirements now being 

proposed, it may be important to more 

clearly prescribe raw product analysis. 

A thorough raw product analysis along 

with the speciation results would 

provide a better picture of the 

combustion of fuels and fuel additives 

than the speciation results alone. 

Because one source of emissions is 

uncombusted fuel and additives, better 

information on the components of the 

raw products might identify potential 

emissions that are not measured in the 

standard emission characterization 

requirements. In addition, raw product 

testing would give more accurate 

information by which products could be 

grouped. 

B. Tier 1: Data Research and Analysis 

In addition to the emission 

characterization procedures described 

above, the requirements of Tier 1 

include a comprehensive search and 

summary of available information 

sources concerning the emissions-based 

effects of fuels and fuel additives on the 

public health and welfare. Data 

modeling applications are also included. 

These requirements are discussed 

below. 

1. Data Search and Summary 

The major functions of the data search 

are twofold. The primary purposes is to 

furnish EPA with a useful compilation of 

existing information obtained from 

previous studies on the composition and 

potential toxicologic and environmental 

effects of fuel/additive emissions. This ' 

body of information is expected to 

provide a contextual overview as well 

as specific factual input for future 

regulatory decision-making by the 

Agency. For this purpose, the data 

search is to encompass available 

information on the chemical 

composition of the fuel/additive 

emissions and on aU emissions-based 

health effects. That is, the required 

information is not restricted to the 

particular endpoints and experimental 

protocols included in Tier 2. The 

secondary function of the data search is 

to enable producers of fuels and 

additivies to document the extent to 

which the emissions characterization 

requirements of Tier 1 and the health 

effects endpoints included in Tier 2 have 

already been addressed by previous 

adequate testing. To mitigate the testing 

requirements of Tiers 1 and 2, reports of 

such previous testing will need to be 

sufficiently detailed to allow EPA to 

judge the adequacy of protocols, 

techniques, experimental design, 

statistical analyses, and data 

interpretation. 

To the extent that such information is 

available, the data search should 
P.38 

Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13203 

address the chemical composition and 

potential adverse effects of whole 

combustion emissions, evaporative 

emissions, and relevant emission 

fractions (e.g., vapor phase and 

particulate phase). In addition, 

information should be sought for each of 

the individual emission products 

identified by the required emission 

speciation procedures, with the 

exception of the regulated emissions. In 

this regard, EPA requests comment on 

the necessity of requiring the data 

search fo be done on identified emission 

products which are designated CAA 

title II or III air toxics. 

Information considered applicable to 

a given fuel or additive includes data 

obtained from the testing of emissions 

from that specific product or from other 

similar products. Products would be 

considered similar to each other if they 

are members of the same fuel/additive 

group (as defined above in section IV) or 

if they qualify fo be members of the 

same fuel/additive group. Thus, 

producers who choose to participate in 

group functions should pool information 

about all member products for purposes 

of their joint submission and should also 

make use of available data on other 

products which are not enrolled in the 

group but share the designated 

formulation characteristics of group 

members. Similarly, a producer who 

chooses not to participate in the 

grouping system should include any test 

results which may be available for 

products which could theoretically be 

assigned fo the same group as the 

producer's own product 

Information on the health and 

environmental effects of fuels and 

additives is to be compiled from peerreviewed scientific journals and otiier 

literature as well as internal industry 

studies, government-sponsored reports 

and assessments, proceedings of 

scientific meetings, and other 

documented sources. Reports of studies 

will be evaluated for adequacy using 

standard EPA guidance documents and 

basic toxicologic and ecologic 

principles. In general, EPA will place 

greater confidence in studies that have 

been subject to peer review. 

Applicable studies may fall into a 

variety of categories. Evidence for 

potential toxicity or lack of toxicity in 

exposed humans may be available from 

epidemiologic studies, clinical studies, 

or case reports. More often, data will be 

available from experiments conducted 

with laboratory animals. In general, 

referenced experiments should be 

concerned with the health effects of 

inhalation exposure to fuel/additive 

emissions. However, data collected from 

studies using other routes of exposure 

may be included if there is sufficient 

justification to extrapolate the results to 

inhalation exposure. Short-term in vitro 

tests, comparative metabolism studies, 

structure-activity analyses, and the 

results of exposure modeling 

approaches are also considered 

relevant. 

If available, data from field studies, 

monitoring exercises, accident 

evaluations, or environmental 

simulation experiments should be 

included to characterize the potential 

impact of fuel/additive emissions on 

vegetation, livestock, companion 

animals, wildlife, aquatic species, soil 

organisms, and natural and synthetic 

materials. Field and/or modeling studies 

on the environmental and atmospheric 

fate of fuel/additive emissions should 

also be included. In addition, the data 

search should cover studies concerning 

the contribution of the fuel/additive 

emissions to odor and visibility 

nuisances. 

Proposed guidelines for conducting a 

comprehensive data search and policies 

for assessing the adequacy of various 

categories of referenced studies have 

been drafted in conjunction with the 

proposed petition process for adding or 

deleting pollutants fo the lists of air 

toxics under CAA Section 112(b) 

(available in Central Docket Section A130, EPA Docket No. A-90-48). EPA 

proposes to apply these general 

guidelines, instructions, and policies to 

the data search and summary 

requirements of the fuels/additives 

registration program. Consistent with 

these guidelines, a search of appropriate 

commercially available toxicologic and 

environmental data bases must be 

conducted to locate information from 

published sources. The search must go 

back for at least fifteen years prior to 

the date of submission, and must be 

current as of six months prior to the 

beginning of testing. Lists of appropriate 

commercially available data bases and 

suggested database search terms are 

provided in the draft air toxics petition 

guidelines referenced above. Given the 

long history of scientific 

experimentation with some fuel 

emissions, comment is requested on 

whether the data search period should 

extend back for a longer period of time, 

e.g., thirty years, rather than for only 

fifteen years. 

The information to be submitted to 

EPA as a result of the data search 

includes the foUowing items: (1) A brief 

text summary of the general findings ' 

and conclusions, (2) a printed copy of 

the outputs from the database searches, 

including reference list and associated 

abstracts, (3) complete documentation in 

scientific journal format of unpublished 

inhouse or other privately-conducted 

studies, and (4) tables summarizing the 

protocols and results of all cited studies, 

organized by health or environmental. 

endpoint and type of emission (e.g., 

combustion, evaporation, and individual 

emission product). In addition, the . 

person(s) or contractor(s) conducting the 

literature search and summary must be 

identified. 

2. Modeling Approaches 

EPA proposes to require the 

application of modeling or other analytic 

methods to provide estimates of ambient 

exposures fo fuel/additive emissions, 

expected atmospheric reactivity of 

various emission products,, and potential 

environmental partitioning of the 

emissions. The principles and 

parameters to be considered in 

implementing modeling approaches for 

vehicle emissions have been reviewed 

in the Health Effects Institute's 

publication, Air Pollution, the 

Automobile, and Public Health

 8

. The 

choice of which models to use is left to 

the applicant provided that the 

applicability, assumptions, limitations, 

and uncertainties of the models are 

clearly delineated. Several examples for 

consideration are described briefly 

below. However, new models are under 

development by scientists at EPA and 

elsewhere and the potential registrant 

would be required to use up-to-date 

techniques when conducting the 

analyses needed to meet Tier 1 

requirements. Comments and 

suggestions from the pubUc concerning 

the selection and application of analytic 

methods would be appreciated. 

Ambient exposures. A 

microenvironmental model developed 

by Melvin N. Ingalls and Robert J. 

Garbe

 6 is one possible method 

identified for deriving preliminary 

estimates of ambient exposures to . 

emission products. This model estimates 

ambient concentrations of fuel/additive 

emissions, for each gram of emissions 

produced per vehicle mile (or vehicle 

minute), for "typical" and "severe" 

situations in six different 

microenvironment8: Residential garage, 

5

 Sexton. K. and Ryan. B.P., Assessment of 

Human Exposure to Air Pollution: Methods, 

Measurements, and Models.and Russell, A.G.. 

Mathematical Modeling of the Effect of Emission 

Sources on Atmospheric Pollutant Concentrations. 

In: Air Pollution, the Automobile, and Public Health. 

(1988) Health Effects Institute, National Academy 

Press, Washington, DC. 

8

 Ingalls. M.N. and Garbe, RJ. (1982) Ambient 

Pollutant Concentrations for Mobile Sources in 

Microscale Situations. SAE Technical Paper Series 

820787. 
P.39 

13204 Federal Register / VoL 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

parking garage, roadway tunnel, street 

canyon, expressway, and expressway 

vicinity. Under this approach, the 

ambient concentration factors provided 

by the models could be used in 

conjunction with the measured emission 

rates for each fuel/additive emission 

product to estimate the exposure 

potential for each emission compound. 

Specific population exposure 

characterizations are provided by the 

SIMSYS

 7 8 and SHAPES 9 models. Each 

of these methods uses both statistical 

and physical approaches to estimate 

emission exposures to individuals and 

to defined populations. SIMSYS can 

characterize high exposure situations 

and SHAPES can be used to model 

exposures to maximally-exposed or 

sensitive individuals. Once modelled, 

actual exposure data specific to the 

microenvironments could be used to 

validate the physical conditions 

predicted in these models. 

EPA's Office of Mobile Sources is now 

completing the development of a new 

hybrid exposure model specific to 

mobile source emissions. The new 

model (HAPEM-MS) incorporates 

elements of both the Hazardous Air 

Pollutant Exposure Model (HAPEM),10 

which is more pertinent to stationary 

source air pollution, and another EPA 

model, the National Ambient Air 

Quality Standards Exposure Model 

(NEM)."

 l 2

 While based on carbon 

monoxide emissions, HAPEM-MS can 

be used to estimate the average annual 

exposure to any mobile source pollutant 

compound of interest and expected to 

be highly applicable to the emissions 

exposure information needs of this 

program. A report describing HAPEMMS and its uses is available in the 

public docket for this proposed 

rulemaking.13 

' Letz. R., et al. (1984) Estimated Distributions of 

Personal Exposure to Respirable Particles. Environ. 

MoniL Assess. 4:351-68. 

8

 Ryan. P.B., et al. (1988) Estimating Personal 

Exposures to Nitrogen Dioxide. Environ. Int. 12:395-

400. 

* Ott W.R. (1983-84) Exposure Estimates Based 

on Computer-Generated Activity Patterns. J. 

Toxicol. Clin. Toxicol. 21:97-128. 

10

 Johnson. T., et al. The Assessment of 

Commuting Patterns in Applications of the 

Hazardous Air Pollutant Exposure Model. 84th 

Annual Meeting of the Air and Waste Management 

Association, Vancouver, BC June 16-21,1991. 

1

 • Johnson. T. and Paul. R.A. (1983) The NAAQS 

Exposure Model (NEM) Applied to Carbon 

Monoxide. PEDCo Environmental. Inc.. Durham. NC 

EPA-450/5-83-004. 

*• Ingalls, MM. (1985) Improved Mobile Source 

Exposure Estimation. Southwest Research Institute, 

San Antonio, TX. EPA-460/3-85-002. 

•* Johnson. T., Paul, R.A., and Capel. 1-E. (1992J 

Application of the Hazardous Air Pollutant 

Exposure Model (HAPEM) to Mobile Source 

Pollutants. International Technology Corporation. 

Durham. NC EPA Contract No. 88-DO-0062. 

Atmospheric transformation. EPA's 

OZIPM4

 I 4

 and Urban Airshed "8 

models are useful for calculating an 

ozone cost or benefit from specific 

emissions. In addition, a model 

developed for EPA and the California 

Air Resources Board by WiUiam 

Carter

 19

 provides estimates of the 

ozone-forming potential of volatile 

organic componds (VOCs) emitted by 

vehicles. The Carter model provides a 

set of scales representing the projected 

incremental effects of 140 different 

VOCs on the formation of 

photochemical ozone under a variety of 

urban airshed scenarios. Knowing the 

weight-percent concentration of 

individual fuel/additive emission 

products, the "maximum incremental 

reactivity" scales can be used to 

estimate the amount of ozone formed by 

these chemical species under conditions 

favorable to ozone production; 

However, uncertainties in the 

atmospheric chemical mechanisms 

related to many of the emitted VOCs 

may significantly affect the accuracy of 

these estimates. The usefulness of these 

models is also limited by the fact that 

they fail fo provide information on 

potentially harmful atmospheric 

transformation products other than 

ozone. Thus, EPA is also considering an 

alternative approach. Rather than using 

mathematical models, a requirement 

could be established for analysis by a 

qualified chemist of the likely 

atmospheric fate of the emission species 

as a result of chemical reactions, 

deposition, and other processes. EPA 

would welcome comments from the 

public on the suitability of these or other 

approaches for estimating the 

atmospheric reactivity of fuel/additive 

emissions. 

An argument can be made that 

requirements for the modeling of 

atmospheric reactivity would lead to 

redundant efforts by many 

manufacturers, since considerable 

overlap would be expected in the 

emission products of different fuels and 

additives (cr groups). According to this 

argument, the duplicate efforts could be 

avoided if EPA itself were to run the 

models when needed, using the emission 

speciation data submitted by the fuel 

and additive manufacturers. Under this 

line of reasoning, once the data on 

primary emission products has been 

submitted, EPA would be in the best 

position to compare the emission 

profiles of different fuels and additives, 

and to use appropriate models to predict 

the implications for atmospheric 

reactivity. 

While this argument appears to have 

some validity, it also contains some 

drawbacks. First different 

manufacturers' submissions would be 

received by EPA at different times, 

interfering with EPA's ability to 

compare the emission profiles of various 

fuels and additives. Such comparisons 

would be difficult to perform in any 

case, and it is Ukely that EPA's attention 

would be drawn to fuels or additives 

which appear to generate unusually high 

concentrations of known precursors to 

harmful transformation products. As a 

result, fuels and additives which might 

provide a relative advantage in terms of 

atmospheric reactivity would tend to be 

overlooked. Such favorable results could 

be important in the overall evaluation of 

a fuel or additive for which certain 

adverse effects were also demonstrated. 

In addition, if EPA were to perform the 

modeling procedures, manufacturers 

would lost the initial opportunity to 

analyze and interpret the modeling 

results and conclusions for their 

products. Comments are requested on 

this possible approach.v 

Environmental partitioning. Examples 

of models which could be used to 

evaluate the environmental partitioning 

of emission products are the Spatial 

Multimedia Compartmental Model 

(SMCM), "• "developed by the National 

Center for Intermedia Transport 

Research at UCLA, and Exposure and 

Ecotoxicity Estimation for 

Environmental Chemicals (E4CHEM),

 19

-

2 0

 developed by GeseUschaft fuer 

Strahlen (GSF) of Munich, Germany. 

These publicly available models predict 

the concentration and mass fraction of 

pollutants in air, soil, water, sediment, 

and biota, thus indicating whether 

terrestrial or aquatic organisms are 

potentially at risk based on the 

" Hogo, H. and Gery, M.W. (1990) User's Manual 

for OZIPM4 (Ozone Isopleth Plotting with Optional 

Mechanisms). Volume i Systems Applic Inc. San 

Raphael, CA. EPA-450/4-89-009a. 

15

 Morris, RX. et al. (1990) User's Guide for the 

Urban Airshed Model. Volume I. Systems Applic 

Inc San Raphael, CA. EPA-450/4/8O-007A. 

: 0

 Carter. W.P.L. (1990) Development of Ozone 

Reactivity Scales for Volatile Organic Compounds. 

Statewide Air Pollution Research Center, Riverside, 

CA. U.S-EPA Contract CR-814398-01-0. 

11

 Cohen. Y. et al. (1990) Dynamic Partitioning of 

Organic Chemicals in Regional Environments: A 

Multimedia Screening-Level Approach, Environ. Sci. 

Technol. 24:1549-1558. 

" Tsal. W.. et al. (1991) Hydrogen Peroxide 

Levels In Los Angeles: A Screening-Level 

Evaluation. Atmos. Env. 25B:87-78. 

'"Trenkle, R. (1988) Fate Simulation of Organic 

Substances in the Atmospheric Mixing Layer. In: 

Environmental Meteorology, K. Grefen and J. Lobel 

(eds), Kluwer Academic Publishers. 

90

 Matthies. M. et Al. (1989) Exposure and 

Ecotoxicity Estimation for Environmental Chemicals 

(E4CHEM): Application of Fate Models for Surface 

Water and Soil. Ecol. Model. 47:115-130. 
P.40 

Register / Vol. 57, Mo. 73 / Wednesday, April 15, 1992 /Proposed Rules 13205 

environmental partitioning of the 

pollutants fo these specific 

environmental media. 

C. Tier 2 Requirements 

The second tier of health effects 

evaluation consists of short-term 

screening tests which address the health 

endpoints previously described. These 

tests will be required for all fuels and 

additives fo the extent that the results of 

the data search activities in Tier 1 do 

not include comparable existing 

information from adequately performed 

and properly documented previous 

studies. Criteria for assessing the 

adequacy of such studies were 

addressed in section III.E.3 of this 

proposal. BPA requests comment on 

whether there are other circumstances 

or product characteristics which would 

indicate that certain fuel families (e.g.. 

methane or propane) should be 

exempted from particular Tier 2 testing 

requirements. 

The proposed health effects testing 

guidelines are included in the regulatory 

text for this proposal, available in the 

public docket or by request to EPA (see 

the section of this Notice entitled. "For 

Further Information"). Most of these 

testing guidelines are modified versions 

of guidelines previously published under 

TSCA (40 CFR part 798). Methods for 

performing animal inhalation exposures 

to fuel/additive emissions are also 

included in the proposed regulatory text. 

Comments and suggestons are solicited 

on the adequacy of these proposed 

guidelines and methodologies for 

promoting vaUd study design and 

adquate technical performance. EPA 

believes that these guidelines (perhaps 

amended for the Final Rule as a result of 

submitted commentary), together with 

published laboratory practice standards 

(referenced below), are sufficient to 

ensure that Tier 2 testing done in 

conformance with these guidelines will 

be acceptable upon subsequent 

evaluation by EPA However, comments 

are requested on whether an optional 

review mechanism should nevertheless 

be established, enabling manufacturers 

to submit detailed protocols to EPA for 

approval before beginning Tier 2 testing. 

Under such a review process, protocols 

reviewed by EPA would earn a 

presumption of technical adequancy, but 

ih view of the large number of individual 

protocols which might be submitted for 

review, significant testing delays could 

occur. Thus, respondents who believe 

that a review mechanism is necessary or 

useful are asked for suggestions on how 

to make the process operate efficiently 

and effectively, given the statutory time 

constraints for program compliance. 

Similar requirements among the 

various test guidelines in regard to 

animal subjects, exposure scenarios, 

and general technical principles provide 

opportunities for concurrent test 

performance at considerable cost 

savings. These shared study parameters 

include the following: 

Laboratory Practices 

To ensure the quality and integrity of 

test results, the performance of all 

studies will be required fo conform with 

the Good Laboratory Practice Standards 

(GLPS) published in 40 CFR part 792. or 

with comparable standards which may 

be developed specifically for this 

program. These GLPS include facility, 

equipment organization, quality 

assurance, and personnel requirements, 

as weU as specifications for proper care 

of laboratory animals, handling of 

reagents and test substances, and 

conduct of studies. In addition, the 

provisions of subpart} of part 792 are to 

be followed for record keeping and 

reporting of results. 

Animal Models 

With the exception of the Ames 

SalmoneUa assay, the proposed test 

requirements entail the exposure of live 

laboratory anirnals fo fuel/additive 

emissions. Mammalian species are 

required, with rodent species 

recommended. The developmental 

toxicity study calls for the exposure and 

assessment of two species, while the 

other studies require only one species to 

be tested. Animal facilities must be 

operated in compUance with the Animal 

Welfare Act as amended and in 

compliance with all pertinent USDA 

regulations. 

Exposure Routes 

Most of the proposed tests are based 

on the inhalation exposure of laboratory 

animals fo diluted whole exhaust and 

evaporative emissions. Such studies 

require an exposure system designed to . 

ensure the controlled generation, 

dilution, and delivery of emissions to the 

laboratory animals. To this end, a 

section of the proposed regulations 

provides a discussion of methodologies 

for conveying either combustion or 

evaporative emissions to the test 

animals, exposure parameters which 

need to be monitored and documented 

during the course of the inhalation 

exposure period, and animal care issues. 

Additional information on the hardware 

requirements, maintenance, and use of 

emission generation and inhalation 

systems can be found in "General 

Health Testing Guideline for Inhalation 

Exposure to Fuels and Fuel Additives". 

(Cheng and Barr, 1991), available in 

public docket A-90-07. 

In the case ofthe in vitro Ames assay, 

bacterial cell cultures rather than live 

animals are exposed fo the test 

emissions. This assay is fo be performed 

using prepared fractions of combustion 

emissions, including an extract of 

filtered particulate matter

 21

 and an 

extract of a sorbent resin which traps 

semi-volatile gases

 2S

. The Ames assay 

will not be required for evaporative 

emissions. 

Exposure Duration, Dosages, and' 

Controls 

The results of recent studies on 

inhaled vehicle exhaust mixtures, as 

compared with similar tests using 

concentrated solutions of single 

chemicals, indicate that exposure 

durations of five weeks or less may riot 

be sufficient to induce observable 

toxicologic changes. Traditionally, the 

next step up in exposure duration is to a 

90-day subchronic test. Because of cost 

considerations, however, the proposed 

test guidelines generaUy caU fora 

minimum six week (42 day) exposure 

period for at least six consecutive hours 

per day, seven days per week. EPA 

requests comment on the adequacy of 

the proposed exposure and on the 

potential importance of extending these 

tests to 90 days for comparability to 

historical data. 

Each study requires exposures to be 

conducted af a minimum of three 

dilutions, corresponding to low. 

midrange, and overtly toxic 

concentrations: A control group exposed 

to filtered conditioned air is also 

required. The objective is to choose, 

exposure.levels tiiat wiU provide a 

lowest-observed-adverse-effect level 

(LOAEL) and a no-observed-adverseeffect level (NOAEL). In recognition of 

the possibility that even high levels may 

be nontoxic provisions are made for 

"limit tests", where appropriate. 

Tests conducted specifically for 

determining the emissions effects of 

additives, which involve mixing the 

additive with an appropriate fuel prior 

to emission generation, require 

additional control studies using the 

emissions of the base fuel alone. A 

possible means of meeting the 

3

' Huisingh, ]. L.. et al. Mutagenic and 

Carcinogenic Potency of Extracts of Diesel and 

Related Environmental Emissions: Study Design. 

Sample Generation. CoUection, and Preparation. In: 

Health Effects of Diesel Engine Emissions. Vol. II. 

W. E. Pepelko. et al. (Eds): US EPA. Cincinnati. 

1980. EPA-eC0/9-60-O57b. pp. 788-800. 

" Stump, F., Snow. R-, et al. (1982) Trapping 

Gaseous Hydrocarbons for Mutagenic Testing. SAE 

Technical Paper Series No. 820778. 
P.41 

13206 Federal Register / Vol. 57. No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

requirement for base fuel control testing 

without duplicative effort was discussed 

previously in section V. 

Brief descriptions of the proposed test 

guidelines for each health endpoint are 

provided in the foUowing sections. A 

possible alternative testing approach is 

also described. 

1. Carcinogenicity and Mutagenicity 

Screens 

A battery of three screening studies is 

proposed, as described below. In these 

studies, mutagenic and/or carcinogenic 

activity is indicated by a statistically 

significant concentration-related 

increase in positive responses after 

exposure to fuel/additive emissions as 

compared to controls (i.e., animals 

exposed to filtered air and, in the case 

of additive testing, animals exposed to 

emissions of the base fuel). The 

detection of a reproducible and 

statistically significant positive response 

to at least one concentration of 

emissions may also be interpreted as a 

positive result. 

Ames reverse mutation assay. The 

Ames assay is an in vitro test for 

mutagenicity and, by implication, for 

carcinogenicity. The assay makes use of 

five mutant strains of the bacterium 

Salmonella typhimurium which cannot 

grow in a medium deficient in histidine 

due to an inherited inability to produce 

this amino acid. Exposure to mutagenic 

(and possibly carcinogenic) subtances 

can elicit reverse mutations, such that 

the bacteria regain their ability to grow 

in a histidine-deficient medium. In this 

test bacteria wiU be exposed to the 

soluble organic (semi-volatile) and 

particulate extracts of fuel/additive 

combustion emissions. (Ames tests will 

not be required for evaporative 

emissions or for the gaseous fraction of 

combusion emissions.) After exposure, 

the cells wiU be plated on histidine/ 

deficient media, both with and without 

metabolic activation, and incubated for 

a designated period of time. The number 

of colonies (revertants) growing on the 

plates wiU then be compared to the 

number of spontaneous revertants in 

control cultures. 

In vivo micronucleus assay. 

Micronuclei are sub-ceUular structures 

containing chromosomes and 

chromosome fragments not incorporated 

into the main nucleus during ceU 

division. While micronuclei do form 

under natural conditions, exposure to 

potentiaUy carcinogenic agents can 

cause an increase in micronucleated 

cells. In this assay, Uve rodents will be 

exposed by inhalation to the fuel/ 

additive emissions. Subsequently, 

erythrocytes obtained from the 

peripheral blood (or, in rats, from the 

bone marrow) will be sampled, stained, 

and viewed under a light microscope. 

The number of normochromatic 

erythrocytes containing micronuclei will 

then be counted and compared with 

normochromatic erythrocytes from 

untreated animals. The use of 

erythrocytes in this procedure facilitates 

the visualization of micronuclei, since 

their primary nucleus is normally 

extruded during ceU development. 

In viro sister chromatid exchange 

(SCE). SCEs are believed to be caused 

by chromosome strand breakage 

resulting in exchanges of genetic 

material between the halves of a 

chromosome "pair" (i.e., the 

chromatids). While some SCEs occur 

normally, an increase in the frequency 

of such exchanges may be indicative of 

mutagenic/carcinogenic activity. In this 

assay, animals which have undergone 

inhalation exposure to vehicle emissions 

will be sacrificed and peripheral blood 

lymphocytes as well as ceUs from lung 

tissue will be isolated and cultured. The 

ceUs will be treated with a DNA base 

analog (bromodeoxyuridine, BrdU) and 

with a spindle inhibitor such as 

colchicine. After appropriate staining for 

labeled DNA sister chromatid 

exchanges wUl be scored from cells 

arrested in the second mitotic division 

and the results compared with 

appropriate controls. 

2. Developmental Toxicity 

(Teratogenicity) Study 

This study is designed to provide 

information on potential dangers to the 

unborn which may arise from inhalation 

exposure of the female to fuel/additive 

emissions during pregnancy. Pregnant 

animals will be exposed to emissions 

during the major organ development 

period in the fetus (e.g., days 6-15 for 

rats and mice). The dams wiU be 

sacrificed on the day prior to normal 

parturition and the uterus examined for 

embryonic or fetal deaths. Viable 

fetuses will be examined for skeletal 

and soft tissue anomalies. These results 

wiU be evaluated relative to the number 

of spontaneous embryonic or fetal 

deaths and abnormalities in appropriate 

controls. The initiaUy proposed test 

guidelines for developmental toxicity 

calls for two different species to be 

examined. However, EPA asks for 

comment on whether one species would 

be sufficient for the screening purposes 

of Tier 2. 

3. Reproduction and Fertility Screen 

The purpose of this test is to 

determine the potential reproductive 

toxicity to adult male and female 

animals caused by inhalation of fuel/ 

additive emissions. Both males and 

females will be exposed to the 

emissions throughout an initial 42-day 

exposure period. In females, vaginal cell 

smears will be examined throughout this 

time, to track effects on the estrous 

cycle. At the end of the initial exposure 

period, a sufficient number of females 

will be mated to obtain at least ten 

pregnant females. Histopathological 

examination of the uterus and ovaries 

will be performed on the non-pregnant 

females, while the adult males.will be 

evaluated by gross and 

histopathological examination of the 

reproductive organs and by assessing 

the number, morphology, and motility of 

sperm. Pregnant females will continue to 

be exposed to the test atmosphere 

throughout the pregnancy, and will be 

examined, along with their offspring, at 

the time of birth and at four days postpartum. 

As compared with appropriate control 

animals, positive results would include 

changes in the number and type of cells 

seen, in vaginal smears, decreases in 

sperm number or motility or 

abnormalities of sperm structure, and 

pathologic changes found during gross 

or microscopic examination of male or 

female reproductive organs. A decrease 

in the number or viability of offspring 

would also be evidence of toxicity. 

4. Pulmonary Toxicity Screen 

This study involves a six-week 

inhalation exposure of laboratory 

rodents to fuel/additive emissions, with 

subsequent examination of lung tissues 

and cells. A satellite group of rodents 

(with control animals) will be exposed 

to the highest concentration of 

emissions in the study for only one 

week. Lung lavage wUl be performed on 

the satellite, group to obtain alveolar 

macrophages for assay of phagocytic 

activity and fluids for biochemical 

analysis. Positive results at the end of 

the exposure period would be indicated 

by elevated enzyme or total protein... 

levels, elevated numbers of cell types 

normally found in the lungs, a low index 

or lack of phagocytic activity, and 

abnormal gross or histopathological 

findings relative to appropriate control 

animals. Persistence or delayed 

occurrence of toxic effects beyond the 

exposure period would also indicate 

positive results. 

5. Neurotoxicity Screen 

The proposed screen for neurologic 

effects is a functional observational 

neurotoxicity battery (FONB) which is 

to be performed on live animals 

periodically throughout a six-week 

period of inhalation exposure to fuel/ 

additive emissions. Using standardized 
P.42 

Federal Kegister / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 13207 

procedures and both positive and 

negative controls to minimize observer 

variability, the functional battery will 

include the assessment of autonomic 

activity, alertness, gross movement, 

behavior, gait, grip strength, and 

reactivity to general stimuli. As 

compared with the controls, positive 

results would include any of the 

following responses and changes: 

Unusual body position, activity level, 

coordination, gait or behavior, tremors 

or convulsions, increased lacrimation or 

salvation, piloerection, pupillary 

changes, unusual respiration, diarrhea, 

increased of decreased urination, 

unusual vocalization, and decreased 

grip strength. 

To completely assess the neurotoxic 

potential of complex fuel/additive 

emissions, additional functional and 

neurdhistochemical tests would be 

necessary. Used alone, the FONB may 

overlook adverse effects at the celluar 

level. Thus, EPA requests comment on 

whether an in vitro assay for 

determining the level of glial fibrillary 

acidic protein (GFAP) *»•** should be 

required in addition to the FONB to 

broadly assess sensitive 

neurohistopathologic effects in tesf 

animals. Another alternative is fo delete 

the FONB and to address neurotoxicity 

by requiring only the GFAP assay. The 

GFAP assay is a sensitive indicator of 

adverse neurotoxicologic effects. 

Because it is an in vitro test which can 

make use of brain tissue harvested from 

exposed animals used in other studies, it 

is also a relatively inexpensive option. 

EPA requests comment on these 

alternative approaches for Tier 2 testing 

of neurotoxic effects. 

6. Optional Histopathology 

If the Tier 1 literature search or 

emissions characterization suggest the 

potential for toxicity to other organ 

systems; then histopathology of the 

indicated organs should be performed, 

using the animals exposed in the 

pulmonary toxicity screen. For ekample, 

if adverse effects to the liver appear 

likely, as suggested from the literature or 

the presence of high levels of PAHs in 

the emissions, then it would be 

advisable to perform histopathology of 

the liver. On the other hand, if 

scientifically sound studies reported in 

the literature indicate no or very 

minimal potential for hepatic effects, 

then liver examination would not be 

" In: Pesticide Assessment Guidelines, 

Subdivision F, Neurotoxicity Test Guidelines (1991). 

EPA-540/09-91-123. 

" OCallaghan; j.P. (1991) Quantification of Glial 

Fibrillary Acidic Protein: Comparison of SlotImmunobinding Assays with a Novel Sandwich 

ELISA. Neurotoxicology and Teratology, 13:275-281. 

necessary. Other organ systems likely to 

be of concern include the kidneys and 

the endocrine glands. These additional 

examinations are suggested because 

findings of potential adverse health 

effects in Tier 1 might require follow-up 

at the Tier 3 level, and if performed as 

adjuncts to required Tier 2 testing, these 

optional histopathology examinations 

might provide substantial incremental 

information at a relatively low 

incremental cost. At a minimum,.organs 

of potential concern should be removed, 

weighed, and saved in storage for 

potential histopathological examination 

at a future time. However,, the length of 

time which organs can be stored and 

still be of use is limited. EPA requests 

comment on whether histopathological 

examination of the liver, kidneys, and 

endocrine glands as an adjunct to the 

pulmonary toxicity screening test should 

be required rather than optional. 

7. Alternative Testing Approach 

An alternative approach under 

consideration by EPA in place of some 

of the proposed Tier 2 tests described 

above is a modified version of a 

protocol developed for use by the 

Organization for Economic Cooperation 

and Development (OECD). The protocol, 

which was developed for use in the 

OECD's Screening Information Data Set 

(SIDS) testing program on high volume 

chemicals, is a screening test which was 

initially developed in the U.S. by experts 

from the government industry, 

academia, and environmental groups. It 

is presently in use for certain toxicology 

applications by 14 countries which are 

members of the OECD as weU as by 

EPA's Office of Toxic Substances. The 

standard protocol is designed as a 

single-study screen for repeat dose, 

reproductive, and developmental effects. 

Currently, efforts are underway at EPA 

to add neurotoxicity measures to the 

protocol, as well. Documentation about' 

the SIDS protocol is available in the 

public docket for this rulemaking. 

While the SIDS protocol might need 

some further modification to 

accommodate exposures by inhalation 

to fuel/additive emissions, it could 

potentially be used in place of the 

pulmonary, reproductive, 

developmental, and neurotoxicity 

screening tests described previously. In 

performing the SIDS test both male and 

female rats would be exposed for a 45-

day period. Males would then be 

examined for repeat dose (including 

pulmonary) effects, reproductive effects 

(sperm number, sperm morphology, 

histopathology of the testis, etc.), and 

neurotoxicity. Females would be 

evaluated for reproductive performance. 

developmental effects and, possibly, 

pulmonary effects. 

While some of the proposed 

individual tests could be performed 

simultaneously in order to reduce 

emission generation and exposure costs, 

the SIDS study evaluates the four 

specified health effects endpoints in a 

single protocol, and might offer 

additional cost savings. On the other 

hand, the SIDS study is more complex 

and the results would include somewhat 

less information for each endpoint in 

comparison with the proposed 

individual tests. Comments are 

requested concerning the use of the 

modified SIDS study as a single-protocol 

substitute for the four specified 

individual screening tests. 

D. Tier 3 Requirements 

Fuels and additives would.be subject 

to additional testing under the proposed 

Tier 3 provisions of the registration 

program as determined on a case-bycase basis by EPA. The endpoints to be 

addressed and the nature ofthe studies 

to be performed would depend on the 

case at hand. Since the overall objective 

of the program is to adequately 

characterize the risk of exposure to fuel 

and fuel additive emissions, the 

applicable Tier 3 requirements could 

include chemical analyses, health 

studies, and/or exposure studies. As 

discussed in Section III, these tests 

would most often be required to further 

explicate the results of the screening 

batteries performed under Tier 2, but 

might also address other areas of 

concern highUghted by the Tier 1 

literature search or emission 

characterization procedures. The need 

for Tier 3 testing would depend on 

whether sufficient toxicity and exposure 

information were available to determine 

whether use pf a fuel or fuel additive . 

presents an unacceptable health risk. 

The criteria for this determination are 

discussed below. 

When a determination has been made 

that Tier 3 testing wiU be required, EPA 

will inform the responsible producer(s) 

by certified mail of the purpose and 

nature of the testing to be performed. 

Subsequently, relevant study guidelines 

and a timetable for completion of aU 

requirements wiU be specified. The 

producer(s) will be expected to submit 

detailed protocols for review and 

approval by EPA prior to beginning the 

tests. Tier 3 testing performed in full 

conformity with a protocol pre-approved 

by EPA for the given product(s) and test 

objective wiU be deemed satisfactory 

compliance with the Tier 3 testing 

requirement. 
P.43 

13208 Federal Register / Vol. 57, No, 73 / Wednesday, April 15, 1992 / Proposed Rules 

1. Need for Discretionary Tier 3 

Determinations 

Given the variety of evaluation 

methodologies and subjects included in 

Tiers 1 and 2 and the wide range of 

possible interrelated outcomes which 

could be obtained, EPA believes that it 

is neither practical nor necessarily 

desirable to specify precise and 

exclusive criteria which would 

automatically cause fuels and additives 

to be subject to Tier 3 requirements. In 

nearly aU cases, decisions on the need 

for Tier 3 will ultimately depend on 

expert scientific judgment as to the 

quality of the evaluation of potential 

health risks which would be possible 

from the avaUable data and tiie need for 

more definitive information in 

developing future regulatory strategies. 

Case-by-case judgments would be 

expected to play a significant role in 

determining if Tier 3 is required even at 

the extremes of possible Tier 1 and 2 . 

outcomes. For example, a high potential 

exposure combined with positive Tier 2 

test results might not necessarily call for 

Tier 3 follow-up if literature search or 

other supporting information were 

avaUable to adequately characterize the 

potential pubUc health risks involved. 

Conversely, relatively low estimated 

exposures and equivocal test results 

might not remove the need for further 

evaluation if the test results were 

inconsistent with other available 

information or with known emission 

product toxicities or if exposures were 

expected to rise significantly in the 

future. In general, because of their 

potentially widespread distribution and 

use, most fuels and high-volume bulk 

additives would have a sufficiently high 

exposure potential to indicate a need for 

Tier 3 testing, provided that Tier 1 and 2 

data suggested the likelihood of adverse 

health effects. 

The discretionary nature of the 

decision process means that the 

elevation of a product (or group of 

products) to Tier 3 need not invariably 

lead to studies of chronic duration. 

Depending on the endpoints and 

protocols involved, additional shortterm analyses, subchronic toxicity tests, 

and/or pharmacokinetic studies might 

be sufficient to clarify risks or allay 

concerns. 

Because Tier 3 requirements are 

proposed to be applied on a 

discretionary basis, and because the 

scope of such requirements could be 

tailored to address individual 

circumstances, the Tier 3 mechanism 

would help to ensure that financial 

resources and laboratory capacity 

would be invested iri areas of real 

concern. A possible alternative 

approach would involve the 

establishment of automatic "triggers", 

i.e., specific outcomes of Tiers 1 and 2 

which would make Tier 3 testing 

mandatory. Associated Tier 3 testing 

requirements would also be specified in 

advance for each trigger. To ensure that 

significant concerns would not be 

overiooked under this approach, 

however, relatively conservative 

conditions would need to be designated 

to serve as the Tier 3 triggers, and 

relatively stringent testing scenarios 

specified as automatic follow-up 

regimens. As a result Tier 3 might be 

triggered more frequently and might 

inclade more rigorous testing 

requirements that would occur under the 

proposed discretionary approach. On 

the other hand, a system of automatic 

Tier 3 triggers and test requirements 

would better enable manufacturers to 

predict and plan for their maximum 

registration responsibilities and would 

simplify EPA's data evaluation tasks. 

EPA requests comment on the relative 

merits of the discretionary vs. automatic 

approaches for determining Tier 3 

applicability. Respondents who prefer 

the automatic approach are also asked 

for suggestions as to the specific 

"triggers" and foUow-up tests which 

should be established. 

• While EPA proposes to retain 

discretion in the decision to require Tier 

3 testing, it is possible to predict some 

sets of circumstances which would 

indieate that Tier 3 will not be required. 

These factors are discussed in the 

sections which follow. EPA requests 

comments on these circumstances, and 

asks for suggestions-on other 

combinations of criteria ("bright lines") 

which could be established to determine 

that consideration for elevation to Tier 3 

is unnecessary. 

2. Criteria for Escalation to Tier 3 

This section presents some of the 

guidelines and considerations which 

EPA Would use in determining the 

necessity for additional testing under a 

discretionary Tier 3 testing approach. 

Consistent with the proposed 

discretionary decision-making process 

for Her 3, this discussion is not intended 

to provide an exhaustive dr definitive 

listing of relevant criteria. Rather, the 

major purpose of this discussion is to 

help furnish a basis for meaningful 

public comments and suggestions on the 

proposed Tier 3 provisions. 

The decision to require manufacturers 

to submit additional testing on the 

health effects of fuel and fuel additive 

emissions would take into account the 

cumulative information provided by 

Tiers 1 and 2, including previous 

scientific data, emissions 

characterization data, modeling 

outcomes, and biological test results. 

Thus, decisions to require Tier 3 would 

be made only after the requirements of 

Tiers 1 and 2 have been adequately 

filled. Adherence to this principle will 

prevent unnecessarily costly or poorly 

targeted decisions based on piecemeal, 

out-of-context information, and will 

promote more precise identification and 

evaluation of data gaps and more costefficient coordination of potential test 

requirements. 

Ultimately, EPA must be able to 

decide whether the use of a fuel or 

additive is likely to create unacceptable 

health risks. If this decision is made 

possible by the information from Tiers 1 

and 2, then Tier 3 would not be needed! 

However, if such a risk decision cannot 

be made on the basis of the Tier 1 and 2 

data, then Tier 3 testing would be 

required. Therefore, to make a ' 

determination on the need for Tier 3 

testing, EPA scientists would evaluate 

the extent to which the results of Tiers 1 

and 2 were adequate for such decisions, 

guided by the basic principles of risk 

assessment. A risk assessment involves 

the merging of a health effects 

assessment (including hazard 

identification and dose-response 

relationships) and an exposure 

assessment. Such an assessment can 

range from a qualitative to a highly 

quantitative analysis, depending upon 

the extent of the available data. 

In most cases, a highly quantitative 

assessment would probably not be 

possible at the end of Tier 2. However, 

Tiers 1 and 2 might indicate that little 

hazard is present and that such 

exposures are quite low and limited 

geographically. In such a case, there 

would be little reason to pursue further 

testing at the Tier 3 level to improve 

dose-response information. In another 

example. Tiers 1 and 2 might suggest 

that a hazard is likely and that 

exposures appear significant, but the -

data may still be inadequate for a 

quantitatively advanced risk 

assessment. In this case, Tier 3 testing, 

targeted to provide the missing 

information, would be indicated. 

In this way, the principles and critical 

data elements of the risk assessment 

process would provide a useful guide for 

identifying significant information gaps 

and determining the specific objectives 

of potential Tier 3 testing. However, 

EPA does not intend to conduct a formal 

risk assessment as part of its decision 

on whether to promote a fuel or fuel 

additive (or group) to Tier 3. Rather, 

EPA would evaluate the quality and 

certainty of available toxicity and doseresponse data and consider qualitatively 
Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 /Proposed Rules 13209 

whether estimated exposure weighs in 

favor of or against further testing. On 

this basis, EPA would determine 

whether additional information is 

necessary to adequately assess the risk 

of fuel or additive. A formal risk 

assessment would be more likely to be 

developed later if there was a need for 

action to control or prohibit a product 

under the regulatory authority of section 

211(c). 

The following section discuss the key 

factors which EPA would consider in 

identifying the need for and content of 

Tier 3 testing. 

a. Statistical issues. As previously 

mentioned, scientific judgment will be 

exercised in determining whether Tier 3 

tests are necessary and, if so, which 

ones. An important factor in such 

judgments wiU be the interpretation of 

and significance ascribed to "negative" 

results obtained in Tiers 1 and 2. 

Evaluating negative data (i.e., no-effect 

data) can be more difficult than 

evaluating positive data, because 

questions often arise as to the reason for 

the negative result: Did aspects of the 

experimental design (e.g., very smaU 

numbers of animals) lead to the negative 

outcome or was the test substance 

inherently of very low or no toxicity? 

This specific question is addressed 

statistically by considering the 

probability of Type I and Type II errors. 

A Type I error occurs when a false 

positive conclusion is made, while a 

Type II error is a false negative 

conclusion. The acceptability of a 

specific Type II error is related to the 

acceptability of false negatives in the 

particular study being performed. For 

example, from a toxicological 

perspective, screening assays often have 

a relatively high probability of 

producing false negative outcomes, 

since some major aspects of organ or 

tissue toxicity are not being examined. 

Thus, an acceptable Type II error for 

screening assays would typically be 

low. However, the level of Type II error 

considered acceptable should be 

tempered by the goal of the study. A 

higher false negative conclusion (e.g., 

Type II error of 0.2) Would generally be 

acceptable if if referred to an effect of 

minimal severity at a high-exposure test 

level relative to ambient concentration 

and if few people were likely to be 

exposed; lhe converse would also hold 

true. 

A number of factors increase the 

complexity of these statistical issues. 

For example, -the design of the study will 

influence the Type I and II levels 

obtained and the standard statistical 

methods chosen. Therefore, the 

scientific quality of the statistical 

analyses and their relationship to the 

experimental design are quite important. 

For example, although minimum sample 

sizes are specified in the proposed 

regulations, these are only general 

guidelines. Variability between 

laboratories and the specifics of tiie 

study methods may allow a decrease or 

require an increase in sample size. 

These possibilities should be evaluated 

properly before the start of the study. 

In summary, scientifically sound 

statistical analyses are a crucial part of 

any good study and will provide key 

information for EPA to use in forming 

judgments on whether or not Tier 3 

testing is needed. While it is not feasible 

to list all possible scenarios and results 

for each Tier 2 endpoint the foregoing 

discussion elucidates how some of the 

statistical factors will be incorporated in 

EPA's decisions. 

b. Exposure assessment. A number of 

the proposed Tier 1 and 2 requirements 

will provide EPA with information on 

population exposures to fuel and 

additive emissions. This information 

includes (1) historical arid/or projected 

production volumes, (2) types and 

emission rates of speciated emission 

components, (3) estimated urban, rural, 

and/or microenvironment exposures 

obtained through exposure modeling 

approaches, (4) evidence for 

bioconcentration from environmental 

modeling results, and (5) possible 

literature search findings on ambient 

occupational, or epidemiological 

exposures. As mentioned above, this 

information will be considered 

qualitatively by EPA in determining 

whether Tier 3 testing is needed. 

Significant public health concerns 

might sometimes be revealed by the 

exposure information itself. This might 

be the case, for example, if there were 

an anticipated release in excess of, say, 

1,000 kg per year of individual emission 

compounds (in addition fo "criteria" 

pollutants) with known toxicities, or if 

the anticipated exposure scenarios 

approached or exceeded current 

estimates of apparently safe levels of 

known toxicants. In the case of fuels 

and their associated high-volume bulk 

additives, EPA wiU generally assume 

that human and environmental 

exposures wiU be of sufficient level and 

extent that significant observed adverse 

effects would indicate a need for followup in Tier 3. This exposure assumption 

reflects the high production and 

consumption of these products, either af 

the present time or as anticipated in the 

future. Thus, decisions fo promote these 

products to Tier 3 would be based on 

the degree to which additional testing is 

needed to clarify the results and 

potential health effect implications of 

Tier 1 and Tier Z data. It cannot be 

assumed, on the other hand, that fuel 

additives used in relatively low 

concentrations or produced in relatively 

low volumes would automatically be 

excused from Tier 3. For these products, 

test results indicative of severe health 

effects and/or high exposure levels in 

circumscribed areas might be cause for 

escalation to Tier 3. 

c. Health assessment. General criteria 

for evaluating the potential public health 

effects associated with fuel and additive 

emissions would include (1) the number 

of positive and negative outcomes 

related to each endpoint, (2) tiie 

identification of concentration-effect 

relationships, (3) the statistical 

sensitivity and significance of such 

studies, (4) the severity of the observed 

effects (e.g., whether the effects would 

be likely to lead fo incapacitating or 

irreversible conditions), (5) the number 

of species involved in the reported tests, 

and (6) the consistency and clarity of 

apparent mechanisms, target organs, , 

and outcomes. Additional parameters 

which would influence the decision on -

whether to require Tier 3 would include 

(1) findings of environmental persistence 

of the emissions and/or the ability of the 

emissions to accumulate in living 

organisms, (2) the nature and amount of 

known toxic agents in the emissions 

stream, and (3) the observation of 

lesions which specifically implicate 

inhalation as an important exposure 

route for inducing adverse health 

effects. 

These criteria would be evaluated in 

conjunction With the results of the 

exposure assessment to determine 

whether or not higher level testing was 

needed. In this decision, both the 

biological and statistical significance of 

the results of Tiers 1 and 2 would be 

taken into account. GeneraUy, 

escalation to Tier 3 would be considered 

when remaining uncertainties about the 

significance of observed outcomes and/ 

or exposures interfered with EPA's 

ability to make reasonable estimates of 

the attendant public health risks. On the 

other hand, if no statistically significant 

effects were obtained at any exposure 

level in a scientifically sound Tier 2 

study (or existing test submitted in lieu 

of Tier 2 testing and not contradicted by 

other published reports of equal or 

greater reliability), and if other major 

sources of concern did not arise (e.g., 

toxic effects of structuraUy related 

compounds), then Tier 3 testing would 

not be required for the endpoint in 

question. This assumes that relevant, 

high-quality statistical analysis had 

been done fo permit the negative test 

results fo be properly evaluated and 

interpreted. The statistical analyses 

. m....*.±m*M 
P.45 

13210 Federal Register / Vol. 57, No. 73 / Wednesday. April 15. 1992 / Proposed Rules 

recommended for Tier 2 in an earlier 

discussion, including determination of 

Type I and II error, should enable 

reasonable conclusions to be drawn as 

to the significance of negative findings. 

Factors to be token into account include 

the toxicological nature of the findings 

and the exposure levels used in the test. 

For example, if the statistical analyses 

were applied to a "severe" endpoint 

(e.g., major fetal abnormalities, major 

lung pathology, etc) and the exposure in 

question was moderate, then 0.1 would 

be an appropriate Type II error level. In 

contrast if a high concentration limit 

test caused a relatively minor effect 

(e.g., a smaU change in lung lavage 

protein), a higher Type II error would be 

allowed (e.g., 0.2), effectively increasing 

the chance of false negative conclusions. 

Evaluation of Tier 2 results. The 

specific outcomes which would be 

considered positive and negative results 

for each proposed Tier 2 test are 

mentioned briefly in the previous 

descriptions of Tier 2 requirements and 

are defined and interpreted more 

precisely in the proposed regulatory 

text For example, three primary studies 

are included in Tier 2 which relate to 

carcinogenicity and mutagenicity: the 

Ames, SCE, and micronucleus assays. 

As compared with appropriate controls, 

a statistically significant dose-related 

positive response in any one of these 

assays could be cause for concern, as 

would positive outcomes for at least one 

concentration in two or more of these 

tests. Such outcomes would be 

indicative of mutagenic risk; however, 

depending on the internal and historical 

consistency of these results and their 

relationship to projected exposures, 

further testing might be required to 

determine the significance of this 

mutagenic activity in human populations 

exposed by inhalation. These outcomes 

would also indicate that the emissions 

could initiate some of the mechanisms 

involved in carcinogenesis. However, 

the production of malignancy is a multistep process, and these results would 

generaUy not in themselves be sufficient 

to determine whether the emissions, 

were in fact carcinogenic. Thus, 

additional testing might be required 

under Tier 3 to better evaluate the 

associated cancer risks. In contrast, if 

no statistically significant results were 

obtained in these three assays and no 

conflicting results found in the literature 

or in other Tier 2 tests, then Tier 3 

follow-up for carcinogenicity/ 

mutagencity would not be required. 

To take another example, 

determination of the need to further 

investigate teratogenic risks would take 

into account the results of both the 

inhalation developmental toxicity study 

and the reproduction and fertility 

assessment of Tier 2. If negative results 

we&e obtained in both of these tests 

(according to statistically sound 

principles), and if these results were not 

refuted by the existing literature, then 

additional testing would not be required 

at the Tier 3 level for developmental or 

reproductive effects. Positive results 

would include a decrease in neonatal 

viability relative to that in control 

studies, a significant change in the 

proportion of viable male vs. female 

fetuses or offspring, the presence of soft 

tissue or skeletal abnormalities, and an 

increased rate of embryonic or fetal 

resorption. Otiier positive outcomes of 

the reproduction and fertility 

assessment, such as abnormal changes 

in sperm structure or function, vaginal 

cytology, or reproductive organ 

histopathology, would be indicative of 

hazards to the adult reproductive 

systems. The need for additional 

evaluation under Tier 3 would depend 

on tie number of species from which 

positive results were obtained, the 

speeiScity, severity, and consistency of 

results, the presence or absence of a 

concentration-effect relationship, and 

the significance of these outcomes in 

view of projected exposure scenarios. 

The greater the remaining uncertainty 

regarding the risk of teratogenic or 

reproductive effects after analysis of 

such factors, the higher would be the 

likelihood that Tier 3 would be required. 

Similarly, consistent negative results 

(according to statistically sound 

principles) obtained in other Tier 2 tests, 

in tiie absence of significant related 

concerns raised in ihe literature, would 

make Tier 3 unnecessary. On the other 

hand, if adverse effects are found at Tier 

2 and/or reported fri the literature, EPA 

would determine if Tier 3 foUow-up is 

required by attempting to evaluate the 

nature, severity, and significance of the 

findings in light ef the likely exposures. 

If EUA determines that Tier 3 testing is 

reqigred to resolve the remaining 

uncertainties, the Tier 3 requirements 

would reflect both positive and negative 

results. For example, if the results of 

Tier 2 were positive for pulmonary 

effeets but negative for neurotoxicity 

(accondwg to criteria discussed earlier), 

and if these results were consistent with 

the literature, only pulmonary toxicity 

would be a likely candidate for Tier 3 

foUow-up testing. 

Aeute health assessment Under the 

assumption that emissions exposures 

will generally be low and thus more 

likely to cause longer-term effects, this 

proposed rulemaking does not focus on 

acute effects. However, the purpose of 

CAA section 211 is to protect the public 

health, whatever the exposure duration, 

and potential acute effects could also be 

a consideration in the Tier 3 decision. 

EPA is currently developing a 

standardized method of assessing acute 

noncancer health effects, and this 

method might be useful for evaluations 

under this proposal program. The new 

method will estimate levels of exposure 

which are expected to pose no or 

minimal health risk to susceptible 

subpopulations as well as levels posing 

incrementally higher risks. A draft of 

this method is expected in early fiscal 

year 1993. After a period for comment 

by EPA's Scientific Advisory Board 

(SAB) and the public, a final draft is 

expected in fiscal year 1994. Thus, the 

new methodology may be available for 

use in a time frame consistent with the 

needs of this program. If acute risk must 

be assessed prior to the availability of 

the approved methodology, then expert 

judgment approaches could be applied. 

EPA seeks comment on these possible 

methods for taking acute health effects 

into account in the determination of Tier 

3 requirements. 

Inhalation reference concentrations. 

Another standardized methodology 

under development by EPA might also 

be applicable to decisions on whether to 

require Tier 3. This process, the 

inhalation reference concentration (RfC) 

methodology, is currently in draft form. 

After incorporation of revisions based 

on SAB and public comments, the report 

is expected to be finalized in fiscal year 

1992. From time to time, EPA.will be 

revising this methodology to reflect 

advances in the state of the art. 

While the present RfC methodology 

recognizes subchronic data, it focuses 

on chronic data, since the RfC is 

intended to address health risk due to 

lifetime exposures. Specifically, a 

chronic RfC is an estimate of a daily 

inhalation exposure to humans 

(including sensitive subpopulations) 

thought to be without appreciable 

noncancer risk over a 70-year lifetime. 

The minimum data base required to 

develop a chronic RfC includes at least 

a 90-day inhalation exposure that 

thoroughly addresses .the potential for 

respiratory tract toxicity and establishes 

a lowest-observed-adverse-effect level 

(LOAEL) and a no-observed-adverseeffect level (NOAEL) for a "critical 

effect." This is a sensitive endpoint that 

plausibly protects against other less 

sensitive effects. The NOAEL and 

LOAEL are adjusted with dosimetric 

extrapolation factors to derive a human 

equivalent NOAEL or LOAEL Various 

uncertainty factors are then applied to 

operationally derive the RfC. A draft 
methodology and minimal verification 

criteria for the RfC are available in 

"Interim Methods for Development of 

Inhalation Reference Doses, U.S. EPA, 

1989 (EPA/600/8-88/066F). 

Assuming the RfCs applicable to fuel 

and fuel additive emissions could be 

derived from Tiers 1 and 2 information, 

they could potentially be used to 

determine testing needs. For example, if 

exposures were in the vicinity of or 

significantly above the RfC, the 

emissions would be considered fo have 

toxic potential and Tier 3 would 

probably be invoked. If exposures were 

substantially lower than the RfC, public 

health concerns would generally be 

allayed. However, the RfC methodology 

would not remove the need to temper 

these conclusions with expert scientific 

judgment. For example, if the adverse 

health effects appeared severe or 

exhibited the potential to progress 

significantly with duration of exposure, 

and if the potentially exposed 

population were large, then signficant 

concern might persist even if 

preliminary estimates of the exposure 

levels were low relative to the RfC. 

Comments are requested concerning the 

possible application of the RfC 

methodology to Tier 3 decision-making 

in the proposed program. 

3. Potential Tier 3 Testing Requirements 

To be most cost-effective, Tier 3 

testing would be designed to specifically 

address data gaps regarding the 

endpoints of concern. Thus, Tier 3 

requirements could potentially include 

further emission characterization 

procedures, perhaps involving i 

additional vehicles, to identify and 

quantify harmful emission products with 

greater precision. Higher-order modeling 

calculations or exposure field studies 

could be required to resolve 

uncertainties in the Tier 1 emissions 

exposure information. Health effects 

testing requirements would be aimed at 

providing sufficient information to make 

sound conclusions about the degree of 

health risk. If more than one endpoint 

were of concern, EPA would attempt to 

reduce testing costs by permitting 

combined protocols and/or inhalation 

exposures insofar as possible. Emission ' 

characterization or.health effects testing 

using emissions generated from 

miscalibrated vehicles or under other 

non-FTP conditions might sometimes be 

included. 

For a quantitative risk assessment, 

health effects test exposures would be 

chosen to permit the determination of a 

NOAEL and LOAEL While Tiers 1 and/ 

or 2 may provide some of this 

information, Tier 3 would typically 

require NOAEL or LOAEL 

determinations for longer duration 

exposures or additional endpoints. If 

chronic inhalation studies are required, 

they would generally be preceded by 

subchronic range-finding studies. These 

would avoid the possibility of designing 

a chronic inhalation test with exposure 

levels so high that excessive mortality 

occurs or so low that a LOAEL is not 

identified. Depending on the endpoints 

under evaluation, consideration would 

also be given to including a midduration examination in the case of 

chronic inhalation tests. A mid-duration 

evaluation would be useful for affirming 

the adequacy of exposure levels and, in 

some cases, might enable interim risk 

conclusions to be drawn which would 

avoid the need for further examination. 

Inhalation studies would generally make 

use of rodent species, but higher order 

mammals might occasionally be 

required. 

While Tier 3 testing requirements 

would be targeted to critical areas of 

concern, EPA would also exercise its 

judgment to avoid the false economy of 

establishing overly narrow 

requirements. Just as requirements for 

too many assays would be wasteful of 

resources, requirements for too few 

assays might result in inconclusive 

findings, creating needs for still further 

testing at greater total expense than 

would have been necessary at the start. 

Similarly, EPA would consider the value 

of including secondary evaluations as 

useful and low-cost adjuncts to tests 

already required. For example, if the 

histopathology of a specified target 

organ were the primary examination 

required at the conclusion of an 

inhalation exposure, other organs could 

be weighed and saved in storage for a 

limited time period, at low incremental 

expense. If indicated, these other organs 

would then be available for subsequent 

examination, avoiding the possible need 

fo repeat the chronic inhalation 

procedures to assess the effects on these 

other organs. 

Because the specific health testing 

requirements which would be imposed 

in Tier 3 would be tailored to individual 

circumstances, precise test guidelines 

cannot be provided in advance. 

However, some of the likely testing 

scenarios which might be required in 

Tier 3 are cited below. Where possible, 

existing TSCA guidelines for these tests 

are referenced. It should be recognized, 

however, that such guidelines might 

need to be revised to accommodate 

emission inhalation requirements and/ 

or to evaluate certain structures or 

functions which the current guidelines 

do not adequately address. Study 

parameters which might require 

modification include exposure routes 

and concentrations, species selection, 

number of animal subjects, examination 

procedures and frequencies, and 

analytic requirements. Furthermore, 

interim advances in the underlying 

science and testing technology may 

provide superior approaches which 

could be available for use by the time 

Tier 3 requirements would be 

implemented. 

Tier 3 follow-up for mutagenicity and 

carcinogenicity concerns raised in Tiers 

1 and 2 would often include a cancer 

bioassay of chronic duration (e.g., 40 

CFR 798.3300 or 798.3320). However, this 

would generally be preceded by shortterm studies to investigate the 

mechanisms involved and, in some 

cases, these shorter tests might be 

sufficient to allay concerns or clarify the 

nature of the risks. Among these 

possibilities is a mutagenicity battery, 

which might include a biochemical 

specific locus test, bacterial DNA 

damage or repair tests, and heritable 

translocation test (40 CFR 798.5195, 

798.5500. and 798.5955). Newer 

procedures, such as cell transformation, 

DNA adducts, and gene amplification, 

would also be considered. In addition, , 

physiologicaUy-based pharmacokinetic 

(PBPK) or metabolic studies (e.g., 40 CFR 

798.7100) might be required. 

Tier 3 evaluation of reproductive and 

developmental toxicity would generally 

involve two generation breeding studies 

(40 CFR 798.4700) and/or reproductive 

assays by continuous breeding 

(RACB)

 2S

. Each of these approaches 

entails approximately 9-12 months of 

exposure. 

Additional evaluation for 

neurotoxicity might include metabolic 

analyses (40 CFR 798.7100), subchronic 

neurotoxicity (including histopathology) 

tests (40 CFR 798.6400), and/or one- to 

two-year chronic inhalation tests (e.g., 

40 CFR 798.3260). Such studies might 

involve neurobehavioral, neurochemical, 

pharmacokinetic, and/or 

histopathological assessments. Because 

fetuses and infants may be particularly 

sensitive to neurotoxicants, special 

studies involving in-utero and neonatal 

exposures might be indicated. 

The foUow-up required for pulmonary 

toxicity concerns would frequently 

involve subchronic and/or chronic 

inhalation studies (40 CFR 798.2450 and 

798.3260), emphasizing histopathology of 

the respiratory tract. If indicated, 

pulmonary function measurements, host 

00

 A protocol developed by the National 

Toxicology Program of the National Institute of 

Environmental Health Sciences is available in the 

public docket. 
P.47 

13212 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992 / Proposed Rules 

defense assays, immunotoxicity tests, 

and enzyme assays of lavage cells and 

fluids might be required in conjunction 

with these exposures. If both chronic 

toxicity and carcinogenesis were of 

cpncern, then a combined protocol (40 

CFR 798.3320) would be in order. 

Tier 3 testing to follow up on Tier 1 

findings would depend on the specific 

identified concerns. EPA anticipates 

that such concerns, identified by 

previous scientific studies in the 

literature or by the occurrence of known 

toxic chemicals in the emissions, would 

most often pertain to potential hepatic, 

renal, or endocrine toxicity, but effects 

on other organ systems or physiologic 

processes are also possible. Potential 

testing might include metabolic, 

subchronic exposure, and/or chronic 

exposure studies (40 CFR 798.7100, 

798.2450, and/or 798.3260). but 

specialized functional, immunologic, and 

enzyme studies might also be required. 

As previously mentioned. Tier 3 

requirements could also include 

additional work to improve the exposure 

estimates submitted in compliance with 

Tier 1. The need for additional exposure 

data would depend in part on the 

limitations of the Tier 1 estimates, and 

in part on the nature of the associated 

health effects information. That is, 

highly precise and accurate exposure 

information would not be cost effective 

if the health assessment were based on 

limited and/or uncertain results, and 

vice versa. 

The approach which EPA plans to use 

in determining the potential need for 

greater precision and accuracy in the 

exposure information is to consider the 

slope of the toxic response. If the slope 

is steep within the range of potential 

human exposures, then a small change 

in exposure is likely to have a major 

impact on the eventual risk assessment. 

Greater precision would thus be 

required in the exposure calculation. If 

adverse health effects appear likely 

within the projected range of exposures, 

improved estimates might also be 

needed to determine tiie conditions and 

locations under which these exposures 

might occur as well as the size of the 

potentially affected populations. On the 

other hand, if only minor health effects 

occur at levels well above ambient 

concentrations and only a relatively 

small number of people are likely to be 

exposed, then additional refinements of 

the exposure calculations would not be 

warranted. 

Tier 3 exposure assessment could 

include physical monitoring studies or 

the application of more sophisticated 

modeling techniques, some of which are 

described in Section VIJ3.2. However, 

the precise nature of these studies 

would be strongly influenced by interim 

advances that are expected in tiie 

growing science of exposure 

assessment. The general topic of 

gasoline exposure is receiving increased 

attention by the scientific community as 

a topic for research, in recognition of the 

limited knowledge base currently 

available for determining the risks from 

mobile source emissions and from the 

use of motor vehicle fuels.28 Thus, new 

information and new scientific 

methodologies for monitoring and 

estimating population exposures are 

expected to emerge in a time frame 

which will be useful for guiding the 

types of exposure assessments which 

might be required at the Tier 3 level. 

EPA requests comments on the 

possible scenarios and test guidelines 

outlined above, and solicits suggestions 

on other health effect and exposure 

studies which should be considered. An 

alternative approach for determining 

Tier 3 testing requirements would permit 

die responsible manufacturers to 

propose testing scenarios which would 

address the areas of concern identified 

by EPA as requiring Tier 3 follow-up 

evaluation. Such proposals would be 

subject to review and approval by EPA 

scientists prior to their implementation 

by the manufacturer in compliance with 

Tier 3. Comments are requested about 

this alternative approach. 

VII. Reporting Requirements 

The materials to be submitted to EPA 

following completion of all Tier 1 and 

Tier 2 requirements are divided into 

three major categories: Basic 

registration data, a summary report, and 

appendices. Producers who must 

conduct additional testing under Tier 3 

will be required to submit a final report 

when the designated Tier 3 testing is 

complete. The nature of the information 

to be included in each reporting 

category is described below. 

A. Basic Registration Data 

The information mandated by existing 

regulations under section 211(b)(1) must 

be submitted (or resubmitted) 

individually for each product being 

registered, using EPA forms which are in 

effect at the time of the submittal. This 

requirement pertains to all previously 

registered fuels and additives, including 

relabeled products, as well as those for 

which first-time registration is sought. 

However, if the basic registration data 

previously submitted for an existing fuel 

or additive is accurate and complete, 

then a statement asserting that this is so 

will suffice in lieu of the submittal of 

** Journal of Exposure Analysis and 

Environmental Epidemiology. January-March, 1992. 

duplicate information. A finding by EPA 

that this information is not in fact, 

accurate and complete as claimed will 

result in the report being considered 

inadequate. 

The basic information currently 

required for fuel and additive 

registration includes product and 

manufacturer identification, 

concentration and purpose-in-use, and 

specific compositional data. In addition 

to these items, information on the 

production volume of each product will 

be required. If tiie producer has 

participated in group efforts to satisfy 

Tier 1 and Tier 2 requirements for the 

product, then identifying information for 

the group must also be provided. 

Similarly, if the producer is relying on 

another manufacturer's (or group's) 

previous registration materials in 

compliance with the testing 

requirements for a new product, then the 

other manufacturer and product (or 

group) must be identified. In addition, 

the producer must certify and provide 

evidence that the first manufacturer has 

been notified. 

B. Summary Report 

This document will provide a text 

summary of the evaluation procedures, 

results, and conclusions pertaining to 

Tiers 1 and 2. A cover page should be 

included, identifying the subject product, 

the manufacturer's name and address, 

and a designated contact person and 

phone number. For group submissions, 

all products and manufacturers to which 

the report pertains must be named, and 

a contact person, address, and phone 

number for the group must be identified. 

If a group submission has been prepared 

under the aegis of a trade or other 

umbrella organization, this organization 

must also be identified. The body of the 

summary report should be divided into 

the following sections: 

1. Executive Summary 

This should consist of a brief 

description of the general results and 

conclusions of Tier 1 and Tier 2 

activities, emphasizing information and 

test data which provide evidence for 

potential adverse health and/or welfare 

effects. 

2. Tier 1 Report 

This section of the summary report is 

intended to provide an overview of tiie 

information provided by Tier 1. Detailed 

procedural descriptions, tables, and 

other outputs are to be included in the 

appendices. 

Literature search. The search methods 

should be described, including the 

identity of data bases, search terms, and 
P.48. 

time periods accessed. Any in-house 

and/or other unpublished studies 

included in the literature search should 

also be described briefly. The results 

and conclusions of the literature search 

with respect fo potential health and 

welfare effects of the subject fuels/ 

additives should be summarized. If test 

documentation provided by the 

literature search has been used to 

satisfy some or aU of the other program 

requirements, the relevant studies 

should be discussed and tiieir adequacy 

fo fulfill the specific purposes of the 

associated program requirements should 

be justified. Finally, the person(s) or 

contractors conducting the search are to 

be identified. 

Emisaion generation and 

characterization. This section of the 

summary report should identify the 

vehicle selected and describe the 

procedures followed in vehicle 

preparation and maintenance and in the 

generation, storage, and processing of 

emissions for testing. A description of 

the analytic methods used to 

characterize the fuel/additive emissions 

products should also be provided. 

Problems encountered in generating 

and/or characterizing the emissions 

should be discussed, including attempts 

fo resolve the problems and their 

potential effects on testing outcomes. 

The laboratories performing these 

procedures should be identified. 

Modeling. The underlying principles, 

functions, and limitations of the chosen 

modeling or other analytic methods 

should be explained, and a.summary of 

results and conclusions provided. 

3. Tier 2 Report 

For each study, the objectives, 

principles, and general procedures 

should be outlined and the findings and 

conclusions summarized. Discussion 

should be included regarding problems 

encountered during the performance of 

the tests and the methods used to 

resolve them. This discussion should 

include the impact which such problems 

may have had on the study outcomes. 

4. Conclusions 

Further testing needs should be 

identified or else a discussion should be 

provided explaining why the results of 

Tiers 1 and 2 should not trigger Tier 3 

testing requirements. 

C. Appendices 

Detailed information in support of the 

general discussions contained in the 

summary report are to be submitted as 

appendices to that report. In regard to 

the literature search, the appendices wiU 

contain (1) summary fables, using the 

format for Table IV suggested within the 

draft petition process guidelines 

associated with the air toxics program 

(available in Central Docket Section A130, EPA Docket No. A-SO-48), (2) a 

complete printed copy of reference lists 

and associated abstracts obtained from 

database searches, (3) complete 

documentation of in-house studies and 

other unpublished information sources, 

and (4) complete documentation (e.g., 

copies of journal articles) of previous 

studies which are being cited in 

satisfaction of emission characterization 

and/or Tier 2 test requirements. 

' Appendices fo the emission 

characterization section will contain 

detailed protocols, copies of all relevant 

laboratory reports, a list of all speciated 

emission products and their emission 

rates, and documentation of calibration/ 

verification procedures. For the section 

on modeling methods, an appendix 

should be provided for detailed 

calculations and results. 

An appendix is also required for each 

of the tests conducted in compliance 

with Tier 2 requirements. These 

appendices should contain the full 

detailed study protocol, complete 

laboratory report statistical analysis of 

the findings, and scientific conclusions. 

These materials should conform to the 

reporting requirements of the individual 

study guidelines as weU as the general 

standards.for record keeping and 

reporting specified in 40 CFR part 792, 

subpart J. A final appendix should be 

provided, containing laboratory 

certifications and associated personnel 

credentials. 

D. Tier 3 Report 

Reports for additional tests required 

under the provisions of Tier 3 should 

include a cover page with identifying 

information as described above for the 

Tier 1 and 2 summary report. The report 

should begin with discussion of the 

concerns arising under the previous tiers 

which led to the Tier 3 requirements, the 

specific objectives of the additional 

studies, and a summary of pertinent 

results and conclusions. This summary 

discussion should be supported with 

appendices containing the kinds of 

documentation discussed above with 

respect to Tier 2: FuU protocols, lab 

reports, statistical analyses, discussion 

of problems and findings, and 

conclusions. The laboratory conducting 

the required tests must be identified, 

and relevant certifications and 

personnel credentials provided. 

VIM. Special Provisions 

A. Exemption for Relabeled Products 

A company's product is registered as 

"relabeled" if it is simply a repackaged 

and rebranded version of a formulation 

which is also registered by the original 

manufacturer. As previously discussed, 

requiring companies which sell 

relabeled products to conduct the health 

and welfare effects assessments 

proposed in today's rulemaking would 

clearly duplicate the efforts of the 

original manufacturer. Thus, under the 

authority of section 211(e)(3)(C), which 

provides thaf the Administrator may 

exempt from the rule any fuel or fuel 

additive upon a finding thaf any testing 

of thaf fuel or fuel additive would be 

duplicative of adquate existing testing, 

relabeled products wiU be exempt from 

the evaluation and testing requirements 

of the registration program. For 

relabeled products, only basic 

registration information will be required, 

as described above in section VILA. Of 

course, this presumes that the 

registration requirements proposed in 

this NPRM would be satisfied for the 

original product by the original 

manufacturer. 

Among the total of 1,160 

manufacturers with one or more 

registered fuel additives as of mid-1990, 

over half (604) registered only relabeled 

additives, and will therefore not be 

required to comply with the health and 

welfare effects assessment provisions of 

the registration program. Relabeled 

additives account for approximately 30 

percent of all additive products 

currently registered. 

B. Applicability of Evaporative 

Emission Testing 

As discussed fully in section IIIC, 

requirements for the chemical 

characterization and toxicologic testing 

of evaporative emissions are proposed 

to apply only to those fuels and 

additives for which vaporization is 

expected to be significant Fuels which 

are supplied by way of sealed 

containment and engine delivery 

systems would thus be exempt from 

evaporative emission requirements, as 

would liquid fuels with RVP less than 

2.0 psi. Methane, propane, and diesel 

fuels would be exempt from evaporative 

emissions testing under this guideline. 

The proposed criteria for determining 

the applicability of evaporative emission 

testing requirements to additives are 

based on (1) the change in RVP of the 

appropriate additive/base fuel mixture 

relative to the RVP of the base fuel. 

alone, and (2) the partial pressure of the 

additive in the additive/base fuel 

mixture. If the presence of the additive 

does not increase the RVP of the base 

fuel by at least 0.1 psi, and if the partial 

pressure of the additive in the additive/ 

fuel mixture in the vapor phase at 1C0 
P.49 

13214 Federal Register / Vol. 57, No. 73 / Wednesday, April 15, 1992'/ Proposed Rides 

degrees Fahrenheit and atmospheric 

pressure is less than 0.1 psi, then 

evaporative emission testing would not 

need to be performed. 

C. Small Business Provisions 

Section 211(e) grants EPA 

discretionary authority to provide 

program exemptions, deferments, or 

modifications for small businesses. 

However, in developing the proposed 

registration program, EPA has carefully 

balanced the desire for rigorous 

scientific evaluation with consideration 

for the associated costs, and has 

included a number of provisions 

designed to decrease the cost burdens to 

aU manufacturers. These general costreduction provisions include: (1) The 

tiered program structure which imposes 

rigorous testing requirements only when 

needed to further explicate significant 

identified concerns, (2) the opportunity 

to share program costs and burdens 

with other manufacturers, (3) the ability 

to rely on existing adequate information 

for compliance with testing 

requirements, (4) the exemption for 

relabeled products, and (5) the general 

reliance on existing regulatory programs 

for evaluating potential emission control 

system effects. In consideration of these 

provisions, EPA is not initially proposing 

to implement the authority to make 

special allowances for small businesses. 

EPA's economic analyses indicate 

that the financial impact of the proposed 

program on most fuel and fuel additive 

producers would be relatively modest 

The median cost per producer is 

estimated to be about $2,000 for 

compliance with Tiers 1 and 2. 

Furthermore, the costs for about 85 

percent of small fuel companies and 70 

percent of small additive companies (as 

defined by the SmaU Business 

Administration) would be less than 

$10,000. Nevertheless, the estimated 

total costs per manufacturer vary 

widely, from about $500 to over $2 

million, depending on each 

manufacturer's number and type of 

products and opportunities for costsharing with manufacturers of similar 

products. Thus, as one might expect, the 

financial impact of the proposed 

program could be significant for some 

small companies. 

As discussed further in section XIV, 

below, a Regulatory FlexibiUty Analysis 

conducted by EPA indicates that smaU 

fuel producers would not be jeopardized 

by the proposed rule, but that nearly six 

percent of smaU additive manufacturers 

(about 1.5 percent of all fuel/additive 

manufacturers) might experience 

financial distress. However, size alone 

does not predict which additive 

manufacturers would be adversely 

affected, and EPA has not yet been able 

to identify what if any, common factors 

place certain small companies at risk. 

Further analysis is expected to clarify 

these factors and, if appropriate, EPA 

may elect to implement special 

provisions for such companies in the 

final rule. 

Various alternative provisions are 

under consideration for this purpose. 

First, the vulnerable companies could be 

excused from one or more of the 

program's requirements. For example, 

they could be excused from all Tier 2 

biological testing or could be required to 

conduct only those Tier 2 tests which 

address the endpoints mandated by 

statute (carcinogenicity, mutagenicity, 

and teratogenicity). Another alternative 

would be to require only the Tier 1 

literature search for such companies. To 

ensure that no small additive companies 

would be financiaUy stressed by the 

regulations, complete program 

exemptions might be necessary. 

However, the potential health and 

environmental effects associated with 

an additive product are generally not 

related to the size of its producer, and 

EPA does not favor this alternative. On 

the other hand, because risk is partly a 

function of exposure, and potential 

exposure to an additive's emissions is 

related to the volume produced and 

sold, appropriate measures of volume in 

conjunction with other relevant 

financial parameters may be reasonable 

to consider in determining possible 

small business allowances. 

Public comment is requested 

concerning these small business issues 

and alternative ideas for possible small 

business allowances or exemptions. 

D. Possible Exemption for "De Minimis" 

Factors 

EPA is considering the creation of 

program exemptions for certain fuel 

additives which are expected to have 

only a "de minimis"impact on the 

composition and biological effects of 

motor vehicle emissions. These 

exemptions are contemplated under two 

sets of circumstances, described below. 

EPA requests comment on each of these 

possible exemptions. 

The first exemption under 

consideration would relate to additives 

which are recommended for use at less 

than 2,500 ppm maximum concentration 

in fuel and which fall into the "baseline 

conventional" categories described 

above in section IV. Because the 

elemental composition of these 

additives is the same as their associated 

base fuels, and because some degree of 

emissions variability is inevitable, it 

may be extremely difficult to distinguish 

the emission products or the emissionsbased biological effects of these 

additives (as mixed in base fuel) from 

the emission products or effects of the 

base fuel alone. These factors are 

reflected in the proposed grouping 

scheme, in which baseline conventional 

additives and fuels are grouped together 

and share the same representatives. 

However, an argument can be made that 

test requirements for these additives J 

would be duplicative of the 

requirements for the related fuels, and 

that a testing exemption for the 

additives might be justifiable under 

section 211(e)(3). 

If the exemption for baseline 

conventional additives were put into 

effect, then the second exemption 

possibility would arise. This potential 

exemption would apply to those 

additives in the "atypical" formulation 

classes (see section TV) which had such 

small concentrations of the atypical i 

components that their emission products 

could be judged to be of negligible 

toxicologic significance. The specific 

concentration criterion for this 

exemption could be established by 

assuming that the toxicity of the atypical 

component was similar to that of a 

known toxic agent (e.g., lead or 

benzene) and then estimating the 

maximum concentration of such a 

toxicant which would result in an 

insignificant exposure risk. 

Comments are solicited in regard to 

possible exemptions under these "de 

Miinlmis"circumstances. Suggestions for 

Vthe^pecific concentration which could 

be used «s-the threshold for granting 

'atypicrfedditive exemptions, and the 

underlylag rationale for selecting that 

threshold, are also welcome. 

E. Possible Temporary Exemption for 

Experimental Fuels and Fuel Additives 

As part of the August 7,1990 ANPRM 

for this action, EPA requested comment 

on whether special provisions should be 

included for low volume fuels and 

additives. In general, commenters on the 

ANPRM did not support a long term or 

permanent exemption for low 

production volume fuels/additives due 

to equity and public health 

considerations. 

Nevertheless, EPA believes that, 

under certain circumstances, a 

temporary exemption for low production 

volume, experimental fuels and 

additives may be appropriate, similar to 

the provisions for experimental 

chemicals under the Toxic Substances 

Control Act (TSCA). Authority for this 

possible provision would be based on 

CAA section 211(e)(3)(A), which permits 

EPA to exempt defer, or modify the 

program requirements for any small 
P.50 

Federal Register X LY.0)-. ??•

 No

-

 7 ? / Wednesday, April 15^/1992 /. Proposed Rules 13215 

business, with "small business" to be 

defined within the regulations. Given 

that compliance costs for this proposed 

program could exceed a mUlion dollars 

for new or unique fuels and additives, 

the proposed testing and evaluation 

requirements could pose a substantial 

barrier to innovation and development 

at a time when both environmental and 

energy concerns are generating 

significant pubUc and private sector 

interest and activity in this area. 

Thus, EPA requests comments on the 

possibility of providing a temporary 

program exemption or deferment for 

experimental fuels and additives. 

Eligibility for this possible exemption 

would be limited to new products, i.e., 

those which were not registered as of 

the effective date of the final rule or, if 

already registered, had not yet been 

placed into wholesale or retail 

commerce. Instead pf meeting the 

program requirements immediately, the 

interested producer would apply to EPA 

for a deferment The application would 

provide details on the chemical, 

physical, and functional properties of 

the fuel or additive involved, the 

purpose of the requested temporary 

exemption, the anticipated volume of 

use, and the expected toxicity and 

exposure related fo the product and its 

combustion and evaporative emissions. 

Information required under 40 CFR 

723.50 covering exemptions for 

Premanufacture Notification under 

TSCA would also be required, lhe 

temporary exemption would require 

EPA approval foUowing submittal of the 

application arid review by EPA 

The temporary exemption would be 

available only when the use of the fuel 

or additive was restricted to 

experimental (research, development 

and evaluation) purposes. No product in 

commercial appUcation, ie., wholesale 

or retail sale, would be eligible for the 

deferment of testing requirements. In 

addition, a volume limitation could be' 

established. For example, the exemption 

could apply only to experimental fuels 

not exceeding, say, 500,000 pounds per 

year or experimental additives not 

exceeding 2,500 pounds per year of 

production or consumption. 

Alternatively, similar to 40 CFR 720.36 

and 40 CFR 780.42(a)(5) promulgated 

under TSCA, no volume limit would be 

placed on production and use. provided 

that the use of the fuel or additive was 

restricted fo experimental purposes. The 

temporary exemption would be good for 

a period of 5 yeara after the exemption 

was approved by EPA but would expire 

if the annual use exceeded any potential 

volume limitations or if the product was 

offered for wholesale or retail sale. EPA 

asks comment on whether additional 

annually renewable exemption periods 

should be permitted. Comment is also 

requested on whether volume 

restrictions should be established and, if 

so, what limitations would be most 

appropriate. 

EX. Compliance Considerations 

As discussed above, the Tier 1 and 

Tier 2 information proposed in this 

rulemaking must be submitted prior to 

registration in the case of fuels and fuel 

additives which are not registered on 

the date of promulgation of the final 

regulations (expected June 1.1993). 

Fuels and additives already registered 

on the date of promulgation must 

comply with the regulations within three 

years following the effective date of the 

final rule. If further testing and 

information submittal is required under 

Tier 3 provisions, a separate timetable 

would be established for compliance 

with such requirements. 

Failure to comply with the 

requirements of the rule could result in 

revocation of a product's registration. In 

addition, direct financial penalties are 

specified in section 211(d) of the statute. 

According to this provision, persons 

who fail to submit any information or 

conduct any tests required by the 

Administrator under section 211(b) shaU 

be liable to the United States for a civil 

penalty of not more than $25,000 for 

every day of such violation plus the 

amount of economic benefit or savings 

resulting from the violation. Each day 

after the due date for submission of data 

shaU constitute a separate day of 

violation. Civil penalties shaU be 

assessed in accordance with sections 

205(b) and (c), which permit EPA to 

proceed either in court or in an 

administrative action. In addition, the 

district courts of the United States have 

jurisdiction to compel the furnishing of 

information and the conduct of tests 

required under section 211(b). 

EPA would consider failure to submit 

information, or submission of 

information that does not comply with 

the requirements of this rule, to 

constitute a violation of sections 211 (b) 

and (e). If a group of manufacturers 

commits to performing joint testing, each 

manufacturer would separately be in 

violation of the rule. However, the 

Administrator would retain the 

authority to remit or mitigate any 

penalty. 

Because EPA recognizes that unusual 

circumstances outside the control of the 

manufacturer may occasionaUy interfere 

with the ability to comply with all of the 

provisions of the rule, tiie proposed 

regulations contain mechanisms to 

allow manufactuers fo request 

modification of the requirements. 

However, EPA expects persons subject 

to this rule fo submit comments about 

the feasibility of the proposed testing 

requirements during the comment 

period, and does not intend the 

modification process fo be used in place 

of such commentary. Instead, the 

purpose of the proposed modification 

process Is to allow only persons who 

experience unforeseen difficulties or 

accidents in conducting the needed tests 

fo request modification of the 

requirements in order to avoid being 

in violation of the rule. However, section 

211(e) requires the requisite (Tier 1 and 

Tier 2) information to be submitted to 

EPA for previously registered products 

within three years after the effective 

date of the rule. Accordingly, EPA 

proposes that modification requests 

must be submitted as soon as the 

manufacturer is aware of the difficulty, 

thus prohibiting persons from waiting 

until the deadline before informing EPA 

of circumstances which might prevent 

EPA from receiving tbe data on time. 

X. Confidential Business Information 

A provision under section 211(b)(2) 

states that the results of health effects 

tests "conducted in conformity with test 

procedures and protocols established by 

the Administrator" shall not be 

considered confidential. Thus, 

information suppUed fo EPA in 

compliance with testing requirements 

wtil be avaUable to the public However, 

the statute specificaUy differentiates 

between health effects test data and 

other information submitted for 

registration. Thus, data on product 

composition arid other registration 

Information not integral to the testing 

program WiU continue to be held in 

confidence. 

XI. Public Participation 

EPA strongly encourages full public 

participation in its decision-making 

processes. In addition to those areas 

where specific comment has been 

requested, EPA solicits comments on ail 

aspects of today's proposal from all 

interested parries. Whenever applicable, 

full supporting rationale, data, and 

detailed analyses should also be 

submitted to aUow EPA to make 

maximum use of the comments. 

Commenters are encouraged to provide 

specific suggestions for improvements fo 

any aspect of the proposal, especially in 

regard to modifications which could 

reduce the costs and burdens of fuel and 

fuel additive registration without unduly 

compromising the scientific accuracy of 

the program or compUance with the 

statutory intent. All comments should be 
P.51 

13216 Federal Register / Vol.

 j57; No. 73 '/ Wednesday. April 'l5,v

i'99i ./ T¥oposefd title s 

directed to the EPA Air Docket Section, 

Docket No. A-90-07 (see 

"ADDRESSES"). Comments will be 

accepted for 30 days after the public 

hearing (see "DATES" and . 

"SUPPLEMENTARY INFORMATION" 

in section. I). 

XII. Statutory Authority 

The statutory authority for this 

proposal is provided by sections 205(b) 

and (c), 211, and 301(a) of the Clean Air 

Act as amended (42 U.S.C. 7524(b) and 

(c) 7545, and 7601(a), Public Law 95-95). 

XIIL Administrative Designation and 

Regulatory Analysis. 

Under Executive Order 12291. EPA 

must judge whether a regulation is major 

and therefore subject to the requirement 

that a Regulatory Impact Analysis (RIA) 

be prepared. Major regulations are 

. defined to be those which have an 

annual impact on the economy of $100 

million or more, have a significant 

adverse impact on competition, 

investment, employment, or innovation, 

or result in a major price increase for the 

affected product 

A regulatory support document which 

presents EPA's analysis of the costs and 

economic impacts of the proposed rule 

is avaUable for review iri the pubUc 

docket EPA estimates that the costs to 

industry for submittal of the proposed 

requisite data for Tiers 1 and 2 would 

total approximately $83 miUion incurred 

over the first three year period after 

promulgation of the final rule. Thus, the 

average annual cost during this period 

would be about $27 miUion. In the 

subsequent three years, Tier 3 

requirements might cost an additional 

$10 million annually. These projected 

overall costs are far less than tiie $100 

miUion annual cost criterion which 

defines a "major rule*'.. Also; the 

proposed rule would not be expected to 

significantly impact competition, 

investment employment or innovation, 

or result in major price increases in the 

industry. 

This proposed regulation was 

submitted to the Office of Management 

and Budget (OMB) for review as 

required by Executive Order 12291. Any 

written comments from OMB and any 

EPA response to OMB's comments are 

available in the public docket for this 

rulemaking. 

While the costs of the proposed 

program would be expected to vary 

widely between various fuel/additive 

groups and amoung individual 

manufacturers, a hypothetical example ' 

may help to clarify the proposed scope, 

time frame, and costs of the program. 

Based on the analysis provided in the 

regulatory support document a possible 

testing scenario and the associated 

compliance costs for a hypothetical 

group of products is discussed below 

and summarized in Figure 6. These costs 

would pertain to the evaluation and 

testing of a fuel selected to represent the 

hypothetical group. The total costs 

would subsequently be shared by all of 

the manufacturers with products 

enrolled in the group. The requirements 

and costs assume that the group consists 

of 40 fuels and additives which contain 

no "atypical" elements, that the group 

does not qualify for exemption from 

evaporative emission testing, and that 

adequate existing studies are not 

available to fulfill any of the speciation 

or biological test requirements. 

Therefore, under this hypothetical 

situation, all of the potential 

requirements of Tiers 1 and 2 must be 

conducted. Combustion emission 

generation procedures are assumed to 

be performed using one Ught-duty . 

vehicle, for both emission 

characterization and biological testing 

purposes. 

FIGURE 6: HYPOTHETICAL COST SCENARIO 

Tier 1 requirements ' 

Oata Research and Analysis 

Vehicle Costs..-

Combustion Emission Generation/SpeciatJon .. _ 

Evaporative Emission Generation/SpeclatJon 

Total Tier 1 Costs ~. 

Tier 2 requirements 

Combustion Emission Generation 

Biological Tests on CombosEvaporative Emission Generation 

Biological Tests on Evaporative Emissions 

Total Tier 2 Costs 

Administrative and Reporting 

Costs. 

Total Tier 1, Tier 2. Administrative Costs 

Total CostsCost 

$16,500 

32,500 

27,000 

. 

4.000 

60.000 

59,000 

294,000 

16,000 

286,000 

- t 

655,000 

157.000 

692.000 

32-2.500,000 

3-3.500,000 

Under this scenario, the cost of 

conducting all requirements of Tier 1 is 

estimated at approximately $80,000. Of 

this, EPA estimates data research and 

analysis (literature search and data 

modeling) costs to be about $16,500, and 

vehicle-related costs (acquisition/ 

operation/mileage accumulation) to be 

about $32,500. EPA estimates a cost of 

$27,000 for generation and speciation of 

combustion emissions, and 

approximately $4,000 for generation and 

speciation of evaporative emissions. 

Further, EPA estimates the costs of 

conducting all Tier 2 test requirements 

to total nearly $655,000 under this 

hypothetical example. Including set-up 

costs, combustion emission generation 

costs are estimated at about $59,000,. 

while biological testing of combustion 

emissions is estimated at nearly 

$294,000. The cost of generating 

adequate evaporative emissions to 

conduct all Tier 2 screening tests would 

be approximately $16,000, and 

conducting Tier 2 tests on these 

emissions is estimated to cost $286,000. 

The administrative costs for 

organizing and administering the group 

and for reporting the Tier 1 and 2 results 

to EPA is judged to be nearly $157,000. 

Adding this to the Tier 1 and Tier 2 costs 

provided above yields a total cost of 

approximately $892,000 for the group as 

a whole. Assuming these costs are 

incurred over a three-year period and 

are divided equally among the 40 

products in the group, the cost to a 

manufacturer with a single product in 

this group would be about $7,300 

annually for three years, or $22,000 in 

total. 

Let us assume further that within 18 

months of receiving the group's report. 

EPA determines that the submittal is 

complete and that the required Tier 1 

and 2 evaluations have been adequately 

performed. However, a number of health 

concerns are raised by the results. The 

literature-search suggests a high 

potential for toxic Uver effects to be 

caused by chronic exposure to the 

combustion emissions of fuels similar to 

those in the group! and the Tier 2 results 

indicate a need for further evaluation of 

possible carcinogenic and pulmonary 

effects of three emissions. In addition, a 

large and widespread population is 

expected to be exposed to the emissions 

of products in tiua group. Thus, EPA 

determines that more rigorous testing is 

necessary under Tier 3 to clarify the 

potential risks posed by this group of 

products. 

Under this hypothetical scenario, two 

tests are likely to be required to address 

the identified areas of concern: A twoyear cornbined chronic toxicity/ 

carcinogenicity study conducted in two 

species, and a metabolism study to 

elucidate the potential carcinogenic 

mechanisms. The group is given three 

years in which to complete these tests. 

The total cost, including costs for 

emission generation and biological 

testing, is estimated at 2 to 2.5 million 

dollars. When divided equally among 

the 40 products in the group and spread 

over the three-year compliance period, 

the Tier 3 testing cost per product in this 
P.52_ 

Federal Register / Vol. 57, No. 73 (J Wednesday, ApriM5i, .1992 /Proposed Rules 13217 

group would be in the range of $17-

21,000 annually for three years. 

In sum, EPA estimates that the total 

costs to this hypothetical group would 

range from approximately 3 to 3.5 

million dollars, incurred over a seven or 

eight year time period. The total cost for 

each product would range from about 

$75,000 to $87,500, averaging about $10-

12,000 per year. EPA seeks comments on 

these estimates, given such a scenario. 

The above discussion illustrates the 

compliance costs which the proposed 

program might entail for a group of fuel/ 

additive producers. However, the 

proposed program could have some 

indirect cost implications, as well. For 

example; if the costs of compliance 

represented a significant barrier to entry 

into the fuel/additive marketplace, real 

social costs (including potential 

environmental costs) could be incurred 

as a result of delayed or deterred 

innovation. These potential social costs 

have not as yet been quantified, and 

EPA requests comment along with 

supporting dafa, on how to evaluate and 

quantify such indirect impacts of the 

program. . 

XIV, CompUance with Regulatory 

FlexibUity Act 

Under section 605 of the Regulatory 

Flexibility Act, 5 U.S.C. 601 et seq., the 

Administrator is required to assess the 

economic impact of this proposed 

regulation on small business entities. 

Accordingly, a Regulatory Flexibility 

Analysis (RFA) has been prepared and 

is avaUable in the public docket. The 

RFA compares the estimated financial 

effects of the proposed programs on 

large and small companies as defined by 

the Small Business Administration. 

Using weighted average financial 

statistics based on a sample of current 

fuel and additive manufacturers, the 

RFA analyzes the impacts of the 

proposed program by projecting the 

effects which the estimated compliance 

costs would have on each company's 

return on assets (ROA). For both fuel 

and additive producers, the analysis 

shows that changes in ROA directly 

attributable to the proposed regulations 

would be greater for small companies 

than large ones. On the average, small 

companies tend to have lower 

compliance costs than large companies, 

but this tendency is outweighed by the 

relatively greater vulnerability of small % 

companies resulting from their much 

lower levels of assets and earnings. 

Among fuel manufacturers, these 

ROA effects do not appear to have a 

significant impact Only two small fuel 

producers in the sample would 

experience a reduction in ROA by as 

much as one percent, and none would 

be driven into severe financial distress 

or closure. Among additive 

manufacturers, however, the. impacts of 

the proposed regulations appear more 

significant. While the impacts on large 

additive companies would be extremely 

minor, the analysis projects that 23 

(almost six percent) of small additive 

companies might experience a reduction 

in ROA to less than 2.5 percent which is 

indicative of financial stress. In 

addition, 18 small companies might be 

pushed into severe financial distress 

(ROA<—4 percent), and two into 

closure (ROA<—30 percent). 

Additional analysis will be needed to 

identify the specific factors which cause 

this subset of smaU additive companies 

to be at particular financial risk. 

Potential allowances for small 

businesses are discussed above in 

section VIII.C. 

XV. Compliance with the Paperwork 

Reduction Act 

The information collection 

requirements in this proposed rule have 

been submitted for approval to the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act, 44 U.S.C. 3501 et seq. An 

information Collection Request 

document has been prepared by EPA 

(ICR No. 309.06) and a copy may be 

obtained from Sandy Farmer, 

Information Policy Branch: EPA; 401 M 

St.. SW. (PM-223Y); Washington. DC. 

20460 or by calling (202) 260-2740. 

Public reporting burden for this 

collection df information is estimated to 

vary from 1 to 1,768 hours per response 

with art average of 440 hours per 

response, including time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing the 

collection of information. 

Send comments regarding the burden 

estimate or any other aspect of this 

collection of information, including 

suggestions for reducing this burden to 

Chief, Information Policy Branch; EPA; 

401 M St. SW., (PM-223Y); Washington. 

DC, 20460; and to the Office of 

Information and Regulatory Affairs, 

Office pf Management and Budget, 

Washington. DC, 20503, marked 

"Attention: Desk Officer for EPA". The 

final rule will respond to any OMB or 

public comments on the information 

coUection requirements contained in this 

proposal. 

List of Subjects in 40 CFR Part 79 

Fuel, Fuel additive. Gasoline, Motor 

vehicle pollution. Penalties, 

Incorporation by reference. 

Dated: April 1,19921 

William K. Reilly. 

Administrator. 

(FR Doc. 92-8066 Filed 4-14-92; fr.45 am) 

BILLING COOE SS60-S0-M