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OAR Box 1827 

Prepped by Charmelle Mathews 

Document Number: 

130) 1-1 

Docket Number: 

A-90-07 

Printed 11/19/2008 12:40:48 PM Sheet 130 of 147 
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Ar-90-o-7 X- 1 

ENVIRONMENTAL PROTECTION AGENCY 

40 CFR Part 79 

WG-9 

EPA AIR D 

Fuels and Fuel Additives Registration Regulations 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Advance Notice of Proposed Rulemaking (ANPRM). 

SUMMARY: This action announces EPA's intent to develop 

regulations and establish program protocols and test procedures 

related to the testing of motor vehicle fuels and fuel 

additives for purposes of registration as prescribed in §211(b) 

and (e) of the Clean Air Act. The regulations are to provide 

for tests to determine potential public health effects and such 

other information as is reasonable and necessary to determine 

emission control system effects and welfare impacts. The 

regulations will apply to current and future fuels and fuel 

additives required to be registered under §211. By law, the 

regulations may also incorporate small business and cost 

sharing provisions and provisions to guard against duplicative 

testing. 
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DATES: EPA will conduct a hearing on this Advance Notice 

of Proposed Rulemaking (ANPRM) on September 26, 1990 in Ann 

Arbor, Michigan. The hearing will convene at 9:00 a.m. and 

will adjourn at such time as is necessary to complete the 

testimony. Written comments on this ANPRM will be accepted 

for 30 days following the hearing. 

ADDRESSES: The hearing will be held at Domino's Farms in 

Ann Arbor, Michigan (313-930-5032). Domino's Farms is 

located on Earhart Road just one quarter mile east of 

Plymouth Road at US-23. 

Comments on the ANPRM 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, (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 12:00 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. 

FOR FURTHER INFORMATION CONTACT: Mrs. Carolyn Krueger, 

Emission Control Technology Division, U.S. Environmental 

Protection Agency, 2565 Plymouth Road, Ann Arbor, MI 48105, 

(313) 668-4274. 

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SUPPLEMENTARY INFORMATION: 

I. Public Hearing 

Any person interested in presenting testimony at the 

public hearing should notify the contact person listed 

above of such intent at least seven days prior to the day 

of the hearing. The contact person should also be provided 

an estimate of the time required for the presentation of 

the testimony and notification of any need for audio/visual 

equipment. A sign-up sheet will be available at the 

registration table the morning of the hearing for 

scheduling the order of testimony. 1^ is suggested that 

sufficient: copies of the statement or material to be 

presented be brought to the hearing for distribution to the 

audience. , 

Mr. Richard D. Wilson, Director, Office of Mobile 

Sources, Office of Air and Radiation, has been designated 

as the presiding officer of the hearing. The hearing will 

be conducted informally, and technical rules of evidence 

will not apply. Written transcripts of the hearing will be 

made. Anyone desiring to purchase a copy of the transcript 

should make individual arrangements with the court reporter 

recording the proceedings. 

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T — 

II. Introduction 

EPA is announcing its plans to implement its statutory 

authority to assess the effects of motor vehicle fuels and 

fuel additives on the public health, welfare, and emission 

control systems. The program being developed is expected 

to be an important means of gathering information about the 

health and welfare effects of fuels and fuel additives. 

Based on the test data and other information obtained, EPA 

will be able to evaluate whether any limits are needed on 

fuels and additives under the statutory criteria in §211(c). 

EPA has recently started the development of the 

proposed rules and welcomes public input regarding the best 

way to structure the program to achieve the Congressional 

goals. EPA is interested in ways to make the program 

manageable, minimize undue burdens, and at the same time 

ensure that an adequate level of testing is done. This 

ANPRM will discuss issues and options involved in 

determining potential public health, welfare, and emission 

control system effects of fuels and fuel additives. 

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This Advance Notice is organized to highlight topic 

areas and issues that are important for program 

development. In some cases, EPA has identified its 

tentative plans as a basis for inviting comment. In other 

areas, where the preliminary plans are less developed, the 

notice raises questions and solicits information from 

commenters. EPA has identified a number of topics and 

questions in this notice upon which it particularly seeks 

comments. Comments and suggestions from the public, the 

affected industry, environmental interests, and the 

scientific community are especially sought. 

The remainder of this notice is, divided into the 

following general areas. Following this introductory 

section, a summary of the statutory authority in this area 

is given together with a chronology of past actions and 

recent developments. This is followed by a fairly broad 

discussion of the design and implementation issues related 

to the fuel and fuel additive testing program. Based on 

this discussion and analysis, the next section describes in 

general terms a possible program approach for health, 

emission control system, and welfare testing and 

assessments. The ANPRM closes with an invitation for 

public participation and a detailed list of questions and 

issues on which EPA desires comment. 

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III. Statutory Background and Provisions 

Section 211(a) of the Clean Air Act (CAA), 42 U.S.C. 

§7545, gives the Administrator the authority to require the 

registration of fuels and fuel additives prior to sale or 

introduction into commerce. EPA issued such regulations in 

1975 (40 CFR Part 79). 

In 1970, EPA was given authority (PL 91-604, December 

31, 1970) to require certain tests and other information 

before registration of fuels and additives. More 

specifically, §211(b)(2) provided that EPA "may also 

require" the manufacturer "to conduct .tests to determine 

potential health effects" (including carcinogenicity, 

teratogenicity, and mutagenicity) of fuels and fuel 

additives and to require other "reasonable and necessary" 

information to identify emissions and their effect(s) on 

the emission control system performance of vehicles or 

vehicle engines and the public health or welfare. Tests 

for health effects are to be conducted according to 

procedures and protocols established by the Administrator 

and any results will not be considered confidential. Also, 

§211(b)(3) states that the Administrator shall grant 

registration if the above provisions are satisfied 

including assurances that the Agency will receive any 

future changes in the information required. 

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Although the general registration regulations were 

implemented in 1975, EPA did not implement the 

discretionary authority to require health, welfare, and 

emission control system effects testing under §211(b)(2) or 

establish procedures and protocols for these tests. In the 

CAA Amendments of 1977, Congress added a requirement to 

§211 (PL 95-95, August 7, 1977). This requirement, 

codified at §211(e), mandates that the Administrator 

implement the §211(b)(2) authority and provides additional 

direction concerning the implementation of the §211(b)(2) 

testing requirements. 

Section 211(e)(1) requires implementation of the 

§2ll(b)(2) authority within one year of enactment of the 

amendments. Section 211(e)(2) also establishes time limits 

by which producers must comply with the regulations. For 

those fuels and additives not registered at the time the 

§21l(b)(2) , regulations are promulgated, the "requisite 

information" must be submitted prior to registration. For 

fuels and additives registered at the time of promulgation 

the information must be provided "no later than three 

years" after promulgation of the §211(b)(2) regulations. 

Section 211(e)(3) allows the Administrator to exempt or 

make special exceptions for any small business, to provide 

for cost and/or burden sharing with respect to any fuel or 

additive manufactured by two or more entities, and to 

exempt any person from such regulations where additional 

testing would be duplicative of adequate existing testing. 

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In an effort to fulfill the §211(e)(l) requirement 

that regulations be promulgated within one year, EPA 

published an ANPRM in 1978 (see 43 FR 38607, August 29, 

1978; Docket ORD-78-01); however, neither a proposed nor 

final rule was issued. Nevertheless, it has always been 

EPA's intention to develop the required regulations. This 

action has remained on the EPA regulatory agenda and a 

development plan for the rulemaking was created in 1988. 

Even though the §211(b) testing requirements were not 

implemented when required, there have been other efforts 

related to fuels and additives over the past ten years. 

The fuel and fuel additives registration program is 

currently operative. Section 211(f) and the EPA 

interpretive rule on "substantially similar" fuels (46 FR 

38582-38586; July 28, 1981) have served to control the 

i 

market entry place of fuels and direct additives absent a 

waiver under §211(f)(4). Also, EPA's Draft Alternative 

Fuels Research Strategy provides broad direction concerning 

the research needed to assess the potential relative public 

i 

health and welfare risks of various fuel formations in 

production, transport, storage, and vehicle use. A copy of 

this "Draft Strategy" is available in the public docket; 

inquiries should be directed to EPA's Office of Research 

and Development. In addition, the literature reflects the 

results of a number of programs conducted to evaluate 

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adverse effects of fuels and additives. A list of many of 

the reports published in this area can be found in Docket 

No. A-90-07. Thus, while the required §211 program will 

provide valuable additional information for assessing risk, 

there have already been some activities that relate to 

fuels and additives. 

Some recent developments have renewed EPA's commitment 

to issue the regulations as called for by the statute. 

First, a July 19, 1989 citizens petition under §21 of the 

Toxic Substances Control Act (TSCA), 15 USC §2620, 

requested the Agency to initiate a rulemaking under §4 of 

TSCA to require testing of methanol fuels by their 

manufacturers and/or processors. An October 17, 1989 

letter from EPA Assistant Administrator Linda J. Fisher 

announced that EPA would initiate a proceeding under the 

joint authority of §211 of the CAA and §4 of TSCA to 

consider health and environmental effects testing of all 

motor vehicle fuels including fuels currently in use and 

those undergoing development. 

Second, a citizens group brought a lawsuit challenging 

EPA's failure to promulgate regulations within the one-year 

period provided for in CAA §2ll(e). Thomas v. Reilly, CA. 

No. 89-6269 (D. Oreg. 1989). EPA has entered into a 

Consent Decree in settlement of this lawsuit, without the 

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adjudication of any issue of fact or law, and the Decree 

has been signed by the Court. Under the Decree, the EPA 

Administrator is to sign a Notice of Proposed Rulemaking 

for publication in the Federal Register by January l, 1992, 

and to sign a Final Rule by June l, 1993. By its terms, 

the Consent Decree "is not addressed to the substance of 

the rulemaking" and nothing in it is to be construed "to 

limit or modify the discretion accorded...by Section 

211...or general principles of administrative law in any 

fashion". 

IV. Fuel and Fuel Additive Program Design and 

Implementation Issues 

• 

A. Introduction 

The CAA requirements clearly indicate that the fuel and 

fuel additive program provided for in §211 is potentially vast 

in scope and raises difficult implementation issues. This 

notice presents the factors that will influence program design 

and discusses how the requirements of the Act can best be 

implemented in light of statutory and practical constraints. 

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The statutory provisions governing the fuel and fuel 

additive program were discussed above. In summary, 

§211(b)(2)(A) requires testing to determine potential 

public health effects of the fuels and fuel additives 

themselves. In addition, §211(b)(2)(B) provides authority 

for obtaining reasonable and necessary information related 

to the emissions resulting from a fuel or fuel additive, 

and the effect of such emissions on the performance of the 

emission control system, and an assessment of the effect of 

such emissions on the public health and welfare. 

Furthermore, §211(e)(2) requires the "requisite 

information" for registration to be supplied to EPA within 

certain time limits and §211(e)(3) jncludes provisions 

which clearly indicate that cost^sharing is to be taken 

into consideration in developing such a program. The 

legislative history also indicates that costs should be 

considered in promulgating test requirements and that the 

regulations are not to be "unduly burdensome". H.R. Rept. 

No. 95-294, 95th Cong. 1st Sess. 308-09 (1977). 

At the same time, there are a number of practical 

factors which affect how these requirements can be 

implemented. First, there are over 6000 active-registered 

fuels and fuel additives which could potentially be subject 

to health, effects tests and the other requirements 

discussed above. This is more than twice the number 

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registered when the §211(e)(l) requirement was established 

and, as discussed below, these are expected to grow in 

number the future. To require all of the approximately 

6000 fuels and additives to undergo extensive individual 

testing concurrently would place onerous administrative 

burdens on the program, would also be very 

resource-intensive and could easily exceed the capacity to 

conduct such tests. Moreover, testing of each fuel and 

additive is not needed if they present essentially the same 

risks of public health and welfare and emission control 

impacts. 

Second, fuels/additives consist of variable complex 

mixtures. Dealing with mixtures and their emissions 

present difficulties in determining what to test (i.e., 

whole mixtures, fractionated components, transformation 

products, etc.) and how to test it. While some detailed 

test procedures do exist for some exposure routes, health 

effect end points, etc., some, as for atmospheric 

transformation products, may be undeveloped. The state of 

knowledge regarding test procedures will significantly 

influence the ability of EPA to prescribe the appropriate 

testing procedures. Furthermore, tests such as long term 

cancer bioassays ordinarily require more time than the 

three-year period specified for submission of requisite 

information for fuels and additives registered at the time 

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the rule is promulgated. In some cases, especially in 

chronic testing, it may not be possible to obtain accurate 

and conclusive results within the prescribed time specified 

by the Act. 

Third/ health, welfare, and emission control system 

impact testing is costly to administer and conduct on a 

case-by-case basis and, given the potential number of fuels 

and additives and types of tests which may need to be 

conducted, the overall costs of an exhaustive program would 

be burdensome. 

Fourth, complicating this further ,is the fact that at 

present there are only a relatively limited number of test 

laboratories capable of conducting such testing and other 

evaluations, and fuel and fuel additives work would not be 

the only ; type of testing being handled at these 

facilities; In addition, testing for atmospheric 

transformation products and their impact on air quality and 

health effects may present an even greater difficulty in 

this area. 

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The statutory requirements and practical constraints 

present what may appear to be a conflict between the goals 

and the means of achieving them. The statute calls for 

health, welfare, and emission system impact testing to be 

done and provides a specified time frame for submitting 

information with due consideration to be given to cost and 

undue burdens. A review of the practical factors suggests 

that this could be difficult since the fuel and fuel 

additive population is large, tests are time consuming, 

costly and sometimes inconclusive, and laboratories and 

other facilities capable of doing the testing are limited 

in number. 

* 

The statutory mandate and its legislative history 

provide for some measures that help alleviate the burden. 

As discussed above, the statute contains provisions for 

cost-sharing and non-duplicative testing, as well as a 

small business exemption. Pursuant to the applicable 

legislative history, costs and the prevention of undue 

burdens are to be taken into account in developing the test 

requirements. Moreover, "relatively inexpensive but 

reliable test methods" are to be used "insofar as 

possible." H.R. Rept. 95-294, 95th Cong. 1st Sess. 309 

(1977). The statute also relies on EPA's judgment in 

establishing the test program. With respect to the timing 

of data submission, EPA has discussed below a number of 

options which could provide additional time for testing 

when more time is needed. 

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In exercising its regulatory judgment, it is. EPA's 

intent to develop a workable, useful program which 

satisfies the goals of the Act, allows for the adequate 

assessment of potential health, welfare, and emission 

control system performance impacts as required, but does 

not introduce an infeasible or needless testing burden on 

the producers of the fuels and additives. Determining 

representative fuels and additives to test, the tests to 

which they should be subjected, and the criteria to be used 

for such determination, will be an important part of this 

rulemaking. The program design needs to focus on the 

potential effectiveness of a given regulatory requirement 

in meeting the goals of the Act and whether the results of 

such requirements will provide useful information for 

decision making. 

The fuel and fuel additive testing program will 

represent a Congressionally-mandated risk assessment for 

potential adverse effects on human health, welfare, and 

emission control system performance. Since risk is a 

function of exposure and toxicity (or effect), one key 

tenet of the program will be to assess potential risk using 

these factors. Consideration will be given to production 

volume and known toxicological or other properties in 

determining the amount of testing needed. Furthermore, it 

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will be important to make appropriate use of the §211(e)(3) 

provisions to reduce costs and eliminate replicate or 

unnecessary testing. Previous testing, the known 

similarity of many fuels and additives, and the current 

state of knowledge of the risks associated with present 

fuels and additives must be taken into account. 

The remainder of this section of the notice discusses 

some of the key program design and implementation issues in 

more detail. This includes more detailed discussions, 

analyses, and requests for comment on both the statutory 

requirements and the practical design factors mentioned 

above. * 

B. Designation of Fuels and Fuel Additives 

Under the current fuel and fuel additive registration 

regulations, motor vehicle gasolines, diesel fuels and 

their additives are the only designated fuels and additives 

for purposes of registration (See 40 CFR Part 79). There 

are currently approximately 2240 active-registered fuels 

and 3790 active-registered fuel additives which means that, 

depending on program design, a significant amount of 

testing could be required. Recent developments in the area 

of alternative fuels suggest that such fuels and their 

additives should also be covered by the regulations 

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covering gasoline and diesel fuels. Given the potential 

for a major expansion of these fuels into the marketplace 

in the future, EPA is now considering issuance of a 

proposal which would designate several additional motor 

vehicle fuels and their additives for registration. (55 

FR 16876, April 23, 1990) This could include: methanol, 

ethanol, or any other motor vehicle alcohol fuel[l], 

liquefied petroleum gas, and compressed natural gas. These 

changes would expand the types of fuels and additives 

requiring registration. 

Given the large number of individual fuels and 

additives involved, EPA is considering .measures to reduce 

the cost/testing burden while at the same time still 

meeting the requirements of the program as called for in 

the Act. Authority for these provisions is found in 

§211(e)(3) of the Act. Section 211(e)(3)(A) provides for 

special requirements for small business. 

[1] Alcohol fuel would likely be defined as a motor 

vehicle fuel containing at least 50 percent alcohol by 

volume. Mixtures of alcohols and gasolines would 

likely be registered as a gasoline if the alcohol 

content was less than 50 percent. 

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Section 211(e)(3)(B) provides for cost/burden sharing 

for a fuel/additive produced by more than one person. 

Finally, §211(e)(3)(C) removes the need for additional 

testing when previous testing is adequate to meet the 

requirements. Discussions and some possible concepts in 

each of these three areas is provided below. 

In addition, EPA recognizes the importance of avoiding 

test requirements which lead to the unnecessary use of 

animals. Each of the concepts below would contribute to 

this objective. Furthermore, later in this notice the 

Agency requests comment on other approaohes, such as tiered 

requirements, the use of non-animal test systems where 

appropriate, and the use of structure/activity and physical 

chemical data which would also limit testing requirements 

and unnecessary animal use. 

C. Provisions to Prevent Undue Burdens 

1. Small Business Provisions 

In order to prevent the testing requirements from 

being unduly burdensome, the CAA gives the Administrator 

authority to exempt or provide deferrals or modifications 

for small businesses; however, "small business" must be 

defined in the regulations. EPA is considering a 

definition including sales/revenue alone or in combination 

with an annual production volume for a given fuel/additive 

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as part of this definition. In addition, the toxicity or 

potential risk of the fuel or fuel additive may be taken 

into consideration. While sales/revenue may be more 

appropriate to get at the ability to pay aspect of a small 

business provision, annual production volume, together with 

the toxicity of the material, is very important when it 

comes to assessing the potential risks to the public 

health, welfare, and emission control system performance. 

EPA requests comment on what sales/revenue thresholds are 

appropriate for different fuels and additives and what 

other financial criteria or other parameters should be 

considered. EPA also requests comment on how the 

requirements for small businesses should be different from 

those that apply in general. The September 30, 1988 User 

Fee Rule under TSCA §26 (40 CFR 700.40) defined a small 

business concern as any person whose total annual sales in 

the fiscal year preceding the date of submission of the 

applicable, §5 notice, when combined with those of the 

parent company (if any), are less than $40 million. A 

similar definition is used for TSCA §8 reporting rules (40 

CFR 704.3). EPA requests comment on the applicability of 

these definitions to the fuels and fuel additives program. 

Producers of fuels and fuel additives are strongly 

encouraged to be certain that the annual production volumes 

they have reported to EPA under the fuel and fuel additive 

registration program are accurate and current. This 

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information ; is essential if EPA is to develop workable 

provisions for small businesses. Inaccurate or incomplete 

information could result in less than optimum provisions 

and the possibility that fuels/additives or individual 

producers thereof would be precluded from small business 

provisions since information was lacking to demonstrate 

that they should have been included. 

2. Cost/Burden Sharing Provisions 

As was discussed above, the provisions of 

§211(e)(3)(B) provide a means to reduce the cost and burden 

of the fuel and fuel additives program^ These provisions 

permit producers of any fuel or fuel additive which is 

manufactured or processed by two or more persons to share 

costs or i responsibilities under the program so that 

requirements can be met without duplication of effort. 

This involves both procedural issues on how producers would 

share the costs and burdens involved and program matters on 

how fuels and additives could be grouped for purposes of 

enacting these provisions. Procedural implementation is 

i 

discussed below. However, the concept of grouping for 

testing purposes has §211(b)(2) implications with regard to 

EPA's approach to implementing protocols, so it will be 

discussed in a separate section. 

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With regard to procedural implementation of this 

provision there are two possible situations. The first 

involves the case where sufficient information exists for 

the registration of a product without the completion of 

additional testing because a manufacturer or other entity 

has already completed the required testing. In this case, 

the first entity has already incurred all necessary costs 

while the second manufacturer might seek to simply use the 

results of this testing as sufficient existing testing and 

claim exemption from further testing (and the associated 

expense). The second case involves two or more producers 

of similar existing or new products who need to undertake 

the same testing requirements prior to. registration. Two 

or more entities would expend the same effort to accomplish 

the same result and would use the limited test facilities 

to duplicate the same tests. 

Section 211(e) allows the Administrator to provide for 

manufacturers of the same fuel or additive to share the 

cost of complying with the regulations and he may also 

provide for meuiufacturers of the same fuel or additive to 

share the responsibilities of complying with testing 

regulations. To implement this authority in the first 

case, the manufacturer who conducts tests of a product 

would be recognized under §211(e)(3)(B) as having a right 

to cost-sharing from others who wish to rely on that 

testing for purposes of §211. These other manufacturers 

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would not be able to use the first manufacturer's test 

results without reaching an agreement on sharing the cost. 

The Agency invites comment on whether the provisions should 

be applicable to provide for cost-sharing when one 

manufacturer has submitted test results that others wish to 

rely upon in meeting their testing obligations. In cases 

where two or more producers need prospectively to complete 

the same testing, they could form a consortium to complete 

the requirements and submit the results as a group. Any 

additional manufacturers desiring to rely on that testing 

for their product would then be charged a fee by the 

original producers to use these results rather than conduct 

their own testing. The Agency requests, comments regarding 

this approach and solicits other suggestions. In all 

cases, under §211(b), the test results submitted to EPA 

would not be confidential. 

EPA also invites comments on some additional matters 

in this area. These cost-sharing provisions would not be 

expected to be available for existing tests if the full 

test results have already been published. Should any 

limits be set for the fees that may be charged for use of 

test information and especially when the tests are a number 

of years old? Should the reimbursement provisions of §4 of 

TSCA be considered a model for handling cost-sharing 

questions? 

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EPA has extensive experience under TSCA §4 with 

cost-sharing for testing. EPA has found that persons 

conducting testing under §4 have chosen in each instance to 

date to work out their own arrangements for cost-sharing or 

reimbursement without any need for EPA involvement. EPA 

issued regulations in 40 CFR Part 791 for data 

reimbursement. In spite of the significant number of test 

rules issued under TSCA, no one has invoked any of the 

formal procedures for data reimbursement under the 

regulations. EPA solicits comment on whether a similar 

result is likely under the §211 testing program. 

» 

3. Grouping of Fuels and Additives for Testing 

As was mentioned above, to implement the §211(e)(3)(B) 

provisions, the regulations may include criteria to 

determine which fuels or fuel additives are essentially the 

same for the purposes of determining potential public 

health effects and meeting other requirements. If the 

fuels or additives are essentially the same as other fuels 

or additives, grouping for testing purposes would prevent 

duplicative testing under §211(e)(3). Fuels and additives 

are complex mixtures and, in grouping them, it is necessary 

to establish criteria for judging if two or more 

fuels/additives are essentially the same. This criteria 

can initially involve evaluation of the chemical 

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composition and/or structural activity properties of 

fuels/additives for the appropriate degree of sameness. 

Such categorization reduces the burden of testing, which is 

important given the great number of compounds involved and 

the lack of test facilities. From each of these groups, 

representative and/or possibly toxic fuels and additives 

could be selected to undergo the testing requirements. 

This would eliminate the need for each fuel and fuel 

additive to undergo testing. To accomplish this end, 

however, potential groups will need to be established as 

well as the criteria by which fuels and additives will be 

assigned to such groups. 

» 

The definition of "essentially the same" by which 

fuels and additives can be grouped can be a very broad 

definition or it can be narrow in scope. A strict 

definition would group fuels and additives according to 

narrow criteria, would emphasize the differences among 

chemicals, and would therefore result in a very large 

number of groups. On the other hand, defining "essentially 

the same" more broadly would result in fewer groups where 

the differences between fuels and fuel additive groups 

could be greater. Under this approach, several 

representatives of the group might be subject to testing, 

whereas only one member may be in the former case. (In 

both cases, this assumes adequate information does not now 

exist). For example, a recent EPA technical memorandum, 

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"Analysis of Aftermarket Fuel Additives Containing 

Methanol" (available in Docket No. A-90-07), shows that a 

large number of the aftermarket fuel additives considered 

contain almost all methanol; however, there is a small 

portion that contains a large number of other compounds as 

well. In trying to group these additives on the basis of 

an "essentially the same" definition it would be necessary 

to determine if they should be grouped together based on 

the fact that they all contain methanol, or they should be 

split into a number of subgroups as deemed appropriate 

based on the other chemical compounds and/or structures 

involved. For each group that is formed, one or more 

representatives could be selected for.testing if needed. 

As can be seen, grouping the products more strictly could 

result in more that would have to be tested. 

The provisions of CAA §211(f) have provided some 

experience with determining fuels and additives which are 

"substantially similar" to other fuels and additives in a 

different setting that focuses on emission control system 

effects. In a 1981 Interpretive Rule (46 FR 38582-38586; 

July 28, 1981), EPA has defined an unleaded gasoline to be 

"substantially similar" to the certification fuel used in 

1975 or later model year vehicles or vehicle engines if it 

contains carbon, hydrogen, and oxygen, nitrogen and/or 

sulfur in some form of hydrocarbon, aliphatic ether, 

aliphatic alcohol (with some limitation on type of 

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alcohol), with fuel additives containing only carbon, 

hydrogen, and oxygen, nitrogen, and/or sulfur, and meets 

certain limitations regarding the amount of fuel additive, 

sulfur in the. additive, and alcohol present in the fuel. 

Fuels not meeting these criteria are not considered 

"substantially similar" to the above-mentioned 

certification fuel. Related materials can be found in the 

public docket. EPA invites comments on whether these 

determinations or similar approaches are useful alone or 

with other factors for grouping fuels/additives for testing 

purposes for determining public health, emission control 

system, and/or welfare effects. Comment is also invited on 

whether the structure activity relationship should be the 

basis for grouping. 

EPA also plans to examine its registration data to 

determine if they provide a useful basis for grouping fuels 

and additives for testing. The results of an analysis to 

be conducted pursuant to a contract will be included in the 

public docket when available. EPA invites comments on the 

appropriate way to group fuels and additives and the 

criteria to be used. The most important concern in 

grouping fuels and additives would be their sameness for 

purposes of potential toxicity and emission control and 

welfare/environmental effects. 

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4. Duplicative and Existing Tests 

Under CAA §211(e)(3)(C), the Administrator "may" 

exempt any fuel or additive from the regulations "upon a 

finding that any additional testing of such fuel or fuel 

additive would be duplicative of adequate existing 

testing." Moreover, under §211(c)(2)(A), the Administrator 

can only control or regulate a fuel on the basis of all 

relevant medical and scientific evidence available to him. 

To structure the testing program and to determine if 

there is duplicative testing, it is important to obtain 

results from existing tests on fuel and fuel additives at 

an early point. It is also necessary to determine what 

testing has been initiated. Since it typically takes 

several years for a report to be made public, to avoid 

unnecessary duplication, it is important to be 

knowledgeable about ongoing work. Testing to deal with 

some of the health, emission or welfare effects of fuels 

and fuel additives may have been conducted for various 

reasons and be available from various sources. 

In connection with this proceeding, to help obtain 

information on existing testing on a timely basis, EPA is 

considering amending the registration provisions in 40 CFR 

79, Subpart D (implemented under §2ll(b)(D), to ensure 

that producers provide a summary of any published testing 

-27-
P.29 

or a detailed report of unpublished results done by the 

producer including tests for EPA or other government 

agencies that relate to health and other effects covered by 

§211. This includes carcinogenicity, mutagenicity, 

teratogenicity and other health effects of raw 

fuels/additives, combustion and possibly atmospheric 

transformation products as well as information on the 

effects of the emissions on the emission control system, 

the environment, and the public health and welfare in 

general. Furthermore, as part of the possible program 

protocol described below, EPA may require the manufacturers 

to conduct a literature search and submit studies or a 

summary of available information relating to the hazards 

and impacts of the fuel(s) or additive(s) the manufacturer 

produces. Such information can be considered reasonable 

and necessary to determine the extent to which emissions 

affect the public health and welfare under §211(b)(2). 

EPA sees this as a key provision and invites comments 

on this measure and on the criteria and procedures that 

should be used to determine whether any fuel or additive 

should be exempt on the grounds that adequate existing 

information exists. 

D. Health Testing Protocols and Requirement Issues 

Section §211(b)(2) provides that tests are to be 

-28-
P.30 

conducted according to test procedures and protocols 

established by the Administrator. The section could be 

read as simply requiring adherence to specific guidelines 

identified by EPA, rather than requiring EPA to establish 

specific test plans or procedures in every case before 

testing is done. EPA might provide for the use of 

generally accepted or best available scientific test 

guidelines or plans in the absence of a requirement for a 

specific procedure. The statute also does not specify the 

extent to which the test requirements should be mandated by 

regulation, identified in guidelines as acceptable models, 

or established on a case-by-case basis. 

» 

Given the large number of fuels and fuel additives and 

the compounds contained therein and the potential number of 

health effects endpoints, identifying appropriate test 

guidelines is important. This section reviews the 

currently available health testing and risk assessment 

guidelines, the factors bearing on the need to develop 

guidelines, and asks for comments on the best approach to 

meet the requirements of the Act. 

1. Existing Health Effects Testing Protocols 

There are several existing sources of established 

health testing guidelines. These include the TSCA, Health 

Effects Testing Guidelines (40 CFR Part 798), Federal 

-29-
P.31 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) 

Toxicology Data Requirements (40 CFR 158.340), and the 

Organization for Economic Cooperation and Development 

(OECD) Guidelines for Testing of Chemicals.[2] 

In addition, there have been several studies 

commissioned throughout the past 10 years which were aimed 

at determining a proposed approach for testing of fuels and 

additives.[3,4,5,6] 

[2] "OECD Guidelines for Testing of Chemicals"; ISBN 

92-64-12900-6; 1981. 

[3] "Possible Approaches to the Health Effects Testing of 

Fuels and Fuel Additives"; Littpn Bionetics, Inc; 

Technical Directive No. 008, EPA Contract No. 

68-02-3682; Draft Report, July 1983. 

[4] "Use of Short-Term Genotoxic Bioassays in the 

Evaluation of Unregulated Automobile Emissions"; 

Litton Bionetics, Inc.; EPA Contract No. 68-02-3682; 

Final Report, October, 1983. 

[5] "Validation of Chemical and Biological Techniques for 

Evaluation of Vapors in Ambient Air/Mutagenicity 

Testing of Twelve (12) Vapor-Phase Compounds"; EPA 

Contract No. 68-02-3170-082; EPA-600/1-84-005; March, 

1984. 

[6] "Testing for Health Effects of Fuels and Fuel 

Additives"; Southwest Foundation for Research and 

Education; EPA Contract No. 68-02-2286; Draft Report, 

1978. 

-30-
P.32 

Each of the five sets of established health testing 

guidelines mentioned above represents generally-formulated 

procedures for laboratory testing of an effect or 

characteristic deemed important for the evaluation of 

health and environmental hazards of a chemical. The health 

effects that are included are primarily acute, subchronic, 

and chronic toxicology (dermal, oral, and inhalation) as 

well as oncogenicity and genetic toxicology. 

i 

These protocols provide guidance and to a varying 

degree details on acceptable models of testing design, but 

more specific guidance may be needed in particular cases. 

However, the potential scope of the fuel and fuel additive 

testing program is such that providing these specifics 

beforehand in each case is generally impractical. EPA 

invites comments on the adoption of these guidelines for 

fuel and fuel additive testing and on the extent to which 

more specific guidance is needed and the manner in which it 

should be provided. 

While resource intensive for EPA and time consuming, 

one possible approach for the more complex and 

comprehensive tests is to provide more specific guidance on 

a case-by-case basis. This approach might require the 

producer to prepare test plans for EPA approval as is 

-31-
P.33 

presently used by EPA in its TSCA §4 test rule for 

dibenzo-para-dioxins/dibenzofurans (40 CFR 766). 

Alternatively, EPA might allow the producer to develop the 

plans and conduct such testing without EPA approval but 

with EPA approval of the acceptability of the results and 

retesting if unacceptable. 

Because of the number of fuels/additives that could be 

tested, it is desirable, if possible, to have model 

guidelines that can be used without the need for a unique 

plan and EPA review in each case. Are the present 

guidelines, particularly the TSCA guidelines, sufficient to 

achieve this goal? Should the guidelines be presumed to be 

appropriate unless, in a particular case, a manufacturer 

shows the need for or appropriateness of using different 

guidelines? 

A major issue is the availability and appropriateness 

of various guidelines for testing emissions/combustion 

products. As is discussed and referenced below, the 

carcinogenicity of diesel fuel as combusted has been 

tested. Do the test protocols used in these studies 

provide an appropriate model for testing of the combustion 

products of fuels and fuel additives? What procedures 

should EPA use for protocol review and at what point should 

these reviews occur if needed? 

-32-
P.34 

In addition to the health effects testing guidelines, 

EPA has also issued five risk assessment guidelines: 1) 

"Guidelines for Carcinogen Risk Assessment" (51 FR 

33992-34003, September 24, 1986); 2) "Guidelines for 

Mutagenicity Risk Assessment" (51 FR 34006-34012, September 

24, 1986); 3) "Guidelines for the Health Risk Assessment of 

Chemical Mixtures" (51 FR 34014-34025, September 24, 1986); 

4) "Guidelines for the Health Assessment of Suspect 

Developmental Toxicants" (51 FR 34028-34040, September 24, 

1986); and 5) "Guidelines for Exposure Assessment" (51 FR 

34042-34054, September 24, 1986). Also, during the last 

few months EPA has proposed new guidelines for reproductive 

risk assessments and a new guideline that supplements the 

guidance in the 1986 exposure guidelines. These are: l) 

"Proposed Guidelines for Assessing Male Reproductive Risk 

and Request for Comments" (53 FR 24850-24869, June 30, 

1988); 2) "Proposed Guidelines for Assessing Female 

Reproductive Risk; Notice" (53 FR 24834-24847, June 30, 

1988); 3) "Proposed Guidelines for Exposure-Related 

Measurements and Request for Comments; Notice" (53 FR 

48830-48853, December 2, 1988); and 4) "Proposed Amendments 

to the Guidelines for the Health Assessment of Suspect 

Developmental Toxicants; Request for Comments, Notice" (54 

FR 9386—9403, March 6, 1989). EPA requests comment on the 

applicability of the risk assessment guidelines to the 

program to be developed under §211(b)(2). 

-33-
2. Laboratory Capabilities 

A second important factor to consider is the 

capability of the nation's testing facilities to handle the 

volume of testing that could potentially be generated both 

in the near term and in the future. EPA invites comment on 

the existing capacity for such testing as well as the 

capabilities among testing facilities. If only a limited 

number of laboratories are capable of performing a certain 

test, the priorities for testing must be carefully 

considered, especially in the short term, so as not to 

unduly burden producers and testing facilities and to 

ensure sound tests. For example, the EPA staff is aware of 

only approximately three facilities capable at present of 

conducting inhalation studies with vehicular combustion 

emissions. EPA especially invites comment from the 

scientific community on the capability of test 

laboratories, and is now conducting an independent study of 

current capabilities. This report, entitled, "EPA Census 

of the Toxicological Testing Industry", will be placed in 

the docket when completed. 

-34-
P.36 

3. Health Effects Endpoints 

As discussed earlier, the CAA provides for the 

Administrator to require testing to determine potential 

public health effects including carcinogenicity, 

mutagenicity, and teratogenicity. Testing is not 

necessarily to be limited to these health effects but, 

rather, may include testing for systemic toxicity, 

cardiovascular and inhalation effects, neurotoxicity, 

metabolic effects, acute effects (oral, dermal, 

inhalation), effects on mucous membranes, etc. The 

legislative history indicates that the testing protocols 

should be "reasonably comprehensive".* H.R. Rept. No. 

95-294, 95th Cong., 1st Sess. 309 (1977). This rulemaking 

will determine which health effect endpoints need to be 

included as part of the testing program. 

4. Exposure Routes and Levels 

Along with determining which health effect endpoints 

to include in the program, the routes and levels of 

exposure to fuels, fuel additives, and their emissions must 

also be decided for animal testing. People are exposed to 

the raw fuel or additive itself through accidental 

ingestion or eye and skin contact. The inhalation of 

vapors also causes contact with the raw fuel or additive. 

-35-
Combustion products as well as atmospheric transformation 

products of the emissions of fuels and additives are 

usually inhaled or may cause a wide array of effects. 

These exposure scenarios indicate that the most likely 

routes of exposure would be inhalation, oral, dermal, and 

ocular. 

Besides route of exposure, in dealing with emissions 

of fuels/additives, it is also important that the pollutant 

level, duration, and pattern of exposure for the test 

protocols be determined. Concentrations used are usually 

much higher in laboratory tests than encountered in the 

environment because the laboratory tests* are conducted on a 

small number of animals and are supposed to provide results 

more quickly than they could be observed in the natural 

situation. Exposure can be a single exposure, long term, 

or can occur at intervals. Periodic exposure can occur at 

regular or varying intervals. In addition, during periodic 

exposure, the concentration can either be uniform or 

increasing/decreasing. 

Since significant exposure to motor vehicle fuels and 

fuel additives is in the form of combustion and atmospheric 

transformation products present in the air they breathe, it 

is appropriate that these be considered in any testing 

program. Atmospheric transport and transformation 

-36-
P.38 

of emissions may lead to increased toxicity. In addition, 

the fuel formulation itself impacts air quality and health 

effects by contributing toward ozone, formaldehyde, and 

other toxics and/or carcinogens. In testing combustion 

products, how should the test sample be determined? Should 

the whole exhaust, fractionated samples, or some 

combination of these be tested and, if so, what criteria 

should be applied? To what extent and in what way should 

this program consider atmospheric transformation products? 

5. TSCA Guidelines and Test Criteria 

EPA is considering using some of tjie basic approaches 

and test procedures implemented under TSCA for evaluating 

chemical substances as guidance in developing testing 

criteria and test methods for fuels and fuel additives. 

The underlying testing philosophy and regulatory approach 

of TSCA would be used as guidance in developing testing 

criteria and test methods for use in the fuels and fuel 

additives testing program. The standardized guidelines for 

health effects, environmental effects, and chemical fate 

tests are found at 40 CFR Parts 795 through 798. 

Under §4 of TSCA, testing of chemicals to develop data 

is required if the Administrator makes certain findings as 

-37-
described in TSCA §4(a)(l)(A) or (B) . In TSCA §4 test 

rules, EPA specifies the individual test requirements. A 

generally formulated set of test procedures, known as TSCA 

test guidelines, are usually adopted as test requirements. 

These guidelines specify, when appropriate, tiered testing 

schemes which use short-term, less expensive tests to 

trigger subsequent, more complex tests or batteries of 

tests. (See, e.g., 40 CFR §§ 799.2500 and 3175) These 

longer-term tests, such as cancer bioassays, are much more 

costly. Determinations of whether longer-term testing is 

necessary are made on an individual chemical basis. 

Under TSCA §5, EPA screens new chemical substances 

before manufacture is permitted to assess their potential 

to cause injury to human health or the environment. Using 

findings similar to those under TSCA §4, if EPA finds that 

available information is insufficient to permit reasonable 

evaluation of the health and environmental effects of a new 

substance and, in the absence of such information, 

activities involving the substance may present an 

unreasonable risk, EPA may regulate activities involving 

the new substance pending development of sufficient 

information. In addition, EPA may regulate a new substance 

where the information is insufficient and the substance 

will or may be produced in substantial quantities and there 

is or may be significant or substantial human exposure to 

-38-
P.40 

the chemical or the substance may reasonably be anticipated 

to enter the environment in substantial quanitities. Such 

testing must be completed and evaluated to EPA's 

satisfaction before unrestricted commercial manufacture or 

import may occur. Tests are selected for these chemicals 

on the basis of the health or the environmental end 

point(s) identified during the assessment. Specific tests 

are frequently based on the TSCA Test Guidelines. 

EPA invites comment on the suitability of the TSCA 

criteria in developing testing requirements and test 

methods for fuels and fuel additives. The legislative 

history of §211(e) indicates that EPA should use relatively 

inexpensive but reliable test methods insofar as possible. 

H.R. Rept. No. 95-294, 95th Cong. 1st Sess. 309 (1977). 

Comments are particularly invited on the suitability of the 

tests used in the TSCA test rules as reliable test methods 

for use under §211 and on the criteria that should apply to 

fuels and additives with a high production volume and a 

significant or substantial level of exposure. 

E. Analysis of Section 211 Time Reguirements for 

Submittal of Requisite Information 

Section 211(e) requires that the "requisite 

information" be provided to EPA by each manufacturer within 

three years for existing fuels and fuel additives, and 

-39-
P.41 

prior to registration for those not registered at the time 

the rule is promulgated. The legislative history for this 

provision indicates that all of the requirements are 

mandatory, as are the dates by which the required test 

information must be submitted by the manufacturer, subject 

to specific statutory exceptions. H.R. Rept. No. 95-294, 

95th Cong., 1st Sess. 308 (1977). 

However, the same report of the House Commerce 

Committee also indicates that the regulations are not 

intended to be "unduly burdensome". The Administrator is 

expected "to take costs into account in promulgating test 

requirements". H.R. Rept. No. 95-294, 95th Cong. 1st Sess. 

309 (1977). The House Committee also expected EPA to 

utilize as far as possible the "[rlrelatively inexpensive 

but reliable test methods" which are becoming "increasingly 

available". The "paramount interest" in protecting the 

public health requires test protocols which are "reasonably 

comprehensive" with respect to a number of health effects. 

Id. 

As was discussed above, there appears to be some 

tension between the full potential scope of the testing 

requirement of §211 and the Congressional goal that the 

implementing regulations not be "unduly burdensome". 

Special difficulties can arise if comprehensive testing of 

-40-
P.42 

all existing fuels and fuel additives must be undertaken 

and completed within three years of the promulgation of the 

regulations. Such a fixed time schedule can be detrimental 

to conducting sound and adequate scientific studies. 

Long-term studies of health effects can often take longer 

than three years. Inhalation tests for carcinogenic 

effects may not show effects until after 30 months of 

exposure. [7] The additional time to set up the study and 

evaluate test results would effectively preclude submission 

of the results within three years. A narrow interpretation 

of this provision would limit testing to those tests that 

are possible to complete in three years rather than tests 

that may be more adequate and appropriate to determine 

potential public health and emission effects. 

As discussed above, a three-year time period to 

complete any required testing would also strain the 

presently available laboratory facilities for conducting 

studies, particularly chronic studies such as inhalation 

studies. While more information on laboratory capability 

is needed, the present indications are that the limited 

test facilities available make it impractical to complete 

all testing of all fuels and fuel additives within three 

years. 

[7] "Health Assessment Document for Diesel Emissions;" 

Office of Research and Development; U.S. Environmental 

Protection Agency; Draft Report; May 25, 1990 
It should be emphasized that at this point much 

remains to be learned about the extent of the additional 

testing that will be needed. Manufacturers may be exempted 

from further testing if adequate existing testing has 

already been conducted. The extent and adequacy of the 

existing testing will have to be determined. Cost-sharing 

by manufacturers is encouraged by the statute and this 

should reduce the amount of testing required for 

essentially the same substances. Furthermore, the 

legislative history encourages the use of relatively 

inexpensive but reliable test methods in so far as is 

possible. 

Still,: some additional testing is likely to be needed 

and these needs may surpass the capability of laboratories 

to complete within three years. EPA invites comment on 

appropriate ways to deal with the tension between the time 

needed for: adequate testing and the limited laboratory 

capabilities on the one hand and the statutory time period 

for submitting requisite information on the other. The 

Agency is exploring several possible approaches and these 

are outlined below for discussion, along with related 

issues. Comments are invited on whether any of these 

approaches should be pursued, or on whether there are 

alternative approaches that should be considered. 

-42-
P.44 

1. Requisite Information 

One approach, which appears sound and consistent with 

the Act, would be to view the requirement in §211(e) that 

"requisite information" be submitted in three years as 

applying to the information and test results that EPA 

determines is needed for regulatory decision making and can 

be completed within the three years. Tests which cannot be 

completed within three years would need to be submitted as 

soon as possible after completion. The statutory text of 

§211(e)(2) i refers to the submission of "requisite 

information" required by regulation to implement the 

authority under §211(b). The authority, under §211(b) that 

EPA is required to implement by §211(e) states that EPA may 

require manufacturers to "conduct tests" to determine 

"potential public health effects," and to submit such other 

information "as is reasonable and necessary" to determine 

emission control and welfare effects. While §2ll(e) no 

longer leaves EPA any discretion on whether to implement 

§211(b), subsection (b) relies on EPA to exercise judgment 

in determining the testing needed to meet the statutory 

aims. 

In the regulations implementing §211(b), EPA would 

exercise its judgment to establish a fuel and fuel 

additives program that will meet the testing requirements 

-43-
P.45 

of the Act. Under such an approach, producers of all 

existing fuels and fuel additives would have to submit 

certain information within three years of promulgation of 

the final regulation. This submission would contain the 

requisite information called for by the regulations 

including the results of screening tests and any other 

testing required and/ or previously completed. Long-term 

tests would have to be submitted if required and if 

possible to complete them. Later submissions of completed 

studies would be permitted when it is not possible to 

submit adequate studies in that time period as discussed 

above. The obligation of manufacturers "to conduct tests" 

would be fulfilled by an undertaking to.complete tests at a 

later time when it is not possible to finish the studies in 

the initial period. In addition, the tests would have to 

be completed and submitted to EPA by any specific date set 

by EPA in a notice to the manufacturers or published in the 

Federal Register. Submission of studies after the initial 

three-year period would also be permitted when adequate 

laboratory facilities are not available to conduct tests in 

that time period and is otherwise needed to meet the 

Congressional goals. EPA would consider identifying 

priorities for completing studies when there are 

insufficient testing facilities. Such an approach is also 

in accordance with §211(b)(3) which provides that 

registrants will give assurances that they will submit 

-44-
additional information which reflects "changes in the 

information required" for registration. 

Furthermore, as discussed above in connection with the 

methanol petition, the Agency also has the option to use 

its authority under TSCA in conjunction with §211 to ensure 

that adequate testing is submitted. TSCA might be used to 

provide additional assurance that studies are completed and 

submitted on a timely basis especially when the tests take 

longer than the three years. 

2. Three-Year Test Period 

* 

Another possibility is that the requirement in §211(e) 

for submitting requisite information in three years for 

registered fuels should be read to apply only to the type 

of tests and information that can be completed and 

submitted in three years. Since Congress expected the 

requirement to be met in three years, Congress must have 

envisioned the use of tests that can be completed within 

this time period. In three years it is more feasible to 

complete literature searches, screening studies, and 

short-term studies as would be consistent with a tier 

testing approach. This type of information can also help 

the Agency make a preliminary assessment of the potential 

for public health, emission control and welfare 

-45-
P.47 

effects. The information can guide the Agency's decision 

making and help to identify the need for further testing. 

If studies take longer than three years to complete, they 

would not be subject to the §211(e) requirement. If 

additional testing is required, the Agency could use its 

authority under TSCA to require the submission of completed 

studies. Moreover, §211(b)(2) and (3) can be viewed as 

authority under which the Agency can continue to require 

additional testing whenever needed even if the tests cannot 

be completed in the three year period identified in §211(e). 

3. Enforcement Discretion 

While perhaps not preferred, another approach would 

recognize that while §211 requires the submission of all 

requisite information within three years, the Agency has 

discretion in taking enforcement action. The Agency could 

issue guidelines that would recognize that, absent unusual 

circumstances, enforcement action would not be an 

appropriate priority when more time is needed to complete 

studies or when the limits on laboratory facilities delay 

the completion of studies. In these guidelines, the Agency 

could identify priorities based on public health factors 

for having tests completed. The aim would be to ensure 

early testing of substances with the greatest potential for 

-46-
extensive adverse effects. See Heckler v. Chanev, 470 U.S. 

821 (1985), and Cutler v. Haves, 818 F.2d 879 (D.C. Cir. 

1987). 

4. Temporary Registrations 

Finally, there is one allied issue related to 

requirements for submission of the requisite information. 

When a particular fuel or fuel additive has not previously 

been registered, but it is essentially the same as a 

registered fuel or additive for which testing is still 

ongoing, should a temporary registration ever be available 

for the new fuel or additive while the testing is being 

completed? Section 211(e) allows registered fuels and 

additives three years to submit the requisite information 

but it requires information regarding new fuels and 

additives prior to registration. A temporary registration 

in this circumstance would help guard against 

anti-competitive effects from the testing requirement when 

the substances pose substantially similar risks. Should 

temporary registrations be available in these or any other 

circumstances? What legal analyses would support their 

availability? 

EPA seeks comments on all of these approaches and 

considerations in developing a plan to implement §211. EPA 

-47-
is still in the process of developing its regulatory 

approach, and is interested in suggestions for any other 

approaches that should be considered. 

F. Other Program Issues 

1. Low Volume Consideration 

As part of establishing protocols and determining 

potential risks, EPA is considering special provisions if 

the overall industry-wide annual production volume is less 

than a given threshold. Low production volumes usually 

result in low exposures and thus a diminished risk and need 

for comprehensive testing. Of course, the potency or 

toxicity of the compounds involved would also have to be 

considered. Comments are requested on this subject, 

including what exceptions would be appropriate and 

information to support any specific definition or exception 

suggested in the comment. EPA also requests comment on the 

applicability of the criteria used under TSCA for 

differentiating low volume, small business entities from 

larger entities. 

2. Reporting Reguirements 

Any testing program that is developed will entail some 

-48-
P.50 

degree of reporting. Exactly how much and in what form 

this information should be submitted needs to be 

established. Currently, for purposes of registration, 

marketers of fuels and additives must submit a fuel or 

additive notification form containing such information as 

the commercial name, chemical composition, percent by 

weight of each component, and purpose in use. This 

information is submitted to EPA on a standard form. With 

respect to the additional information that will need to be 

provided once testing regulations are promulgated, how 

shall this information be submitted? EPA does not intend 

to accept summaries of unpublished data; therefore, a 

detailed report would be necessary. For research that has 

been published in peer-reviewed literature, EPA believes a 

summary of the report will be adequate. Shall this 

information be submitted on standard forms or shall the 

format be the responsibility of the registrant? The Agency 

requests comments on the reporting detail necessary and on 

the type of format to use. 

3. Evaluation of Test Results and Determination of 

Regulatory Action. 

Once adequate tests have been completed and the 

requisite information has been submitted to EPA, the Agency 

will need to assess the submissions to be sure adequate 

testing has been done and to determine whether any further 

-49-
P.51 

testing or regulatory action is needed. One value of the 

testing program is the information it provides to the 

decision making process. In addition, §211(c) provides 

that, based on the information obtained under §211(b), the 

Agency may control or prohibit fuels or fuel additives 

which "may reasonably be anticipated to endanger the public 

health or welfare" or impair emission control systems. 

Before taking any such action the Administrator must 

consider all relevant information available, including 

other means of achieving emission standards. The 

Administrator must also conduct a cost-benefit analysis 

comparing emission control systems that require the 

proposed control or prohibition with those that do not. In 

addition, under §211(c)(l)(C), the Agency cannot prohibit 

the fuel or additive if the restriction would lead to the 

use of any other fuel or additive which will endanger the 

public health or welfare to the same or greater degree. 

If, however, a more suitable substitute became or was 

available that was less dangerous to the public health or 

welfare, then action could be taken to restrict the more 

hazardous fuel/additive. 

These determinations call for careful analysis and 

considerable information. The starting basis for judging 

what action is needed is the existence and degree of risk 

posed to the public health and welfare or emission control 

-50-
P.52 

system. EPA invites comment on the appropriate process it 

should use to evaluate test results submitted under §211(b) 

to determine the adequacy of the testing done, and the 

existence of a risk to the public health and welfare and 

the appropriate regulatory action to be taken in light of 

the constraints identified in §211(c). 

One possible alternative would be for EPA to evaluate 

the test results as an internal process as part of a 

determination whether further testing or regulatory action 

is necessary. Under this approach, if EPA decided a 

control or ban of the fuel or additive was necessary, it 

would commence rulemaking under §2il(c). If it decided no 

regulatory action was required, no formal announcement 

would be made and no formal public evaluation would be made 

by EPA of the test results submitted. The test results 

themselves would be public under §21l(b). 

An alternative approach would be for EPA to establish 

a formal review process to evaluate the test results on a 

scientific basis, to determine the need for more tests, and 

announce publicly the extent to which the studies submitted 

are adequate and either show or do not show a potential 

public health risk or welfare effect and the degree of risk 

involved. Such a review process may or may not involve 

participation by outside scientific experts to advise EPA. 

-51-
P.53 

Comment is invited on whether the Agency should establish a 

formal review process to evaluate the results of the 

testing done and the form any review should take, and the 

priorities for reviewing the test results for different 

categories of fuels and fuel additives. 

Consequences of Failure to Submit Requisite 

Information 

When the §211(b) regulations are issued, EPA will need 

to ensure that such regulations are followed and the 

requisite information is submitted. The CAA contains 

specific provisions that need to be considered in ensuring 

compliance with §211. Under §2ll(d), the manufacturer can 

be assessed a $10,000 civil penalty for each and every day 

of failure to submit information required under subsection 

(b). In addition, under §211(e), a new fuel or fuel 

additive is to provide the requisite information prior to 

registration. 

Section 211(c) also provides for the issuance of 

regulations to restrict the use of fuels and fuel additives 

under certain conditions. Section 211(e) provides that the 

Agency's regulations "shall require" the submission of 

requisite information within the prescribed time frame, and 

the legislative history of §211(e) suggests that if the 

requisite information is not submitted within three years 

-52-
for registered fuels and additives the Agency's regulations 

"should provide that such registration shall be deemed to 

be revoked". H.R. Rept. No. 95-294, 95th Cong., 1st Sess. 

308 (1977). This provision can be viewed as authorizing 

regulations that provide for revocation when the requisite 

information is not provided. If the regulations provide 

for revocation of the registration , EPA invites comment on 

the procedural safeguards that should be provided and on 

whether any administrative procedures should be afforded in 

advance before any registration for an existing fuel or 

additive is considered revoked. 

* 

Lastly, EPA invites comment on the consequences that 

should follow when the producer of an unregistered fuel or 

fuel additive submits all the test data and other requisite 

information required for registration but the information 

submitted indicates that the fuel or additive poses an 

unreasonable risk to the public health or welfare or to an 

emission control system. One possibility is to view 

§211(b) as implicitly authorizing denial of registration 

when an unacceptable risk is shown. Another alternative is 

to view §211(b) solely as an information-gathering 

provision with §2ll(c) governing risk-based regulatory 

actions. Under this approach, the procedures and criteria 

of §2ll(c) would have to be used if the Agency wished to 

deny registration based on nature of the risks shown by the 

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P.55 

tests or information submitted for registration. If 

§211(c) is the basis for regulating a risk, may the Agency 

deny registration while a proposed regulation under §21l(c) 

is pending which would prohibit or limit the use of the 

fuel or additive? 

V. Possible Program Protocols 

A. Health Effects 

The requirements and test protocols in the health 

effects program must be coordinated and structured to yield 

the information needed to determine whether or not the 

product may cause the health effects of concern. This 

includes collection of currently available health effects 

and other information needed to assess risk as well as the 

generation of additional health effects data through 

testing when the presently available data is insufficient. 

The overall structure can follow a matrix or tiered format 

or a combination of both. A matrix would be a set of 

requirements of which all would need to be completed. 

Tiers would be set up as sequential levels of requirements 

where lower level would need to be completed prior to the 

higher levels. 

The health effects program being considered by EPA 

-54-
combines features of both a matrix and tiered format. It 

would be set up with various tiers, and within some tiers 

there would be a set or matrix of tests and/or other 

requirements that would have to be completed. 

Fuels/additives would have to sequentially complete one or 

more tiers depending on the findings in each tier. This 

program would be formulated such that producers would only 

have to complete the tiers needed to gather the health 

effects information required for decision making, without 

having to subject each fuel/additive to a predetermined 

full array of tests that may be unnecessary and 

prohibitively costly. The health effects program being 

considered by EPA would consist of four tiers and a matrix 

or set of requirements within each tier. It would be 

designed to be as self-implementing as possible. Each of 

these is discussed below. 

An explanation of the first tier requires the 

development of concepts involving "base fuels" (without 

direct additives), "base additives", and their potential 

health effects. First, to qualify as a base fuel/additive, 

there would have to be adequate existing health effects 

testing information to determine potential public health 

effects for regulatory decision making. (EPA specifically 

requests comment on whether adequate health effects testing 

information currently exists to qualify any particular 

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P.57 

fuel/additive as a "base fuel/additive" at this time and, 

if not, requests specific recommendations as to what 

additional information is needed for a candidate 

fuel/additive to qualify. As noted above, EPA has included 

in Docket No. A-90-07 a list of many of the published 

reports on existing fuels.) Second, EPA would seek to 

develop definitions/specifications for base fuels/additives 

such that any fuel/additive which would meet the 

specification for a given base fuel/additive would have 

essentially the same potential public health effects. 

Comments are invited on the criteria to be used. Thus, the 

first tier would involve the basic concept of comparing 

other fuels and additives seeking registration under 

§211(b)(2) to the specifications EPA would develop for base 

fuels/additives. Existing fuels and additives could also 

seek to show by suitable information that they meet 

appropriate specifications for the base fuel/additive. 

Assuming base fuels additives are identified, the 

fuels/additives which conform to appropriate specifications 

of base fuels/additives would not be required to undergo 

further health effects testing unless new concerns arise in 

the future: 

Thus, the basic tier 1 requirement would involve 

reporting of information including physico/chemical 

properties, production volume, concentration in use, and 

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P.58 

chemical composition and structure activity relationship, 

if needed, for each fuel or additive. Producers who 

believe that their fuels/additives would meet the 

specifications for one of the base fuels/additives would 

submit data and other analysis called for in the 

regulations providing justification for their view. No 

further health effects testing would be required for those 

fuels/additives found to meet the specifications for a base 

fuel/additive for such testing would be duplicative of 

adequate existing data. For those fuels/additives found 

not to fall within the specifications for a base 

fuel/additive, the presumption would be that EPA does not 

now have sufficient information for regulatory decision 

making and the fuel/additive would have to proceed to tier 

2. 

The goal of the tier 2 requirements would be the 

collection and submission of existing health effects 

information for the fuels/additives in question. It would 

require the producer to conduct a thorough literature 

search (public and in-house) for physico/chemical 

information, health effects studies, analyses, data and any 

other relevant information related to both the raw 

fuel/vapor, combustion products, and possibly atmospheric 

transformation products of the fuel/additive. This would 

cover information on all of the human health effects of 

-57-
interest, including but not limited to carcinogenicity, 

mutagenicity, teratogenicity as well as other acute, 

subchronic and chronic effects discussed previously in this 

notice. As part of the rulemaking EPA will need to more 

specifically define what health effect endpoints must be 

assessed beyond those specified in §211(b)(2)(A). As part 

of this tier, a producer would make any request for a 

finding under §211(e)(3)(C) that additional testing of the 

particular fuel/additive would be duplicative of adequate 

existing testing. 

If health effects information is supplied to address 

all of the health effects endpoints identified in tier 2, 

the fuel/additive would not be required to enter tier 3. 

If relevant gaps exist in the health effects information 

submitted, then the fuel/additive would be required to 

enter tier 3. It is in tier 3 where producers would be 

required to conduct any needed short- or medium-term health 

effects tests. If the information from tiers 2 and 3 show 

a possible health effects concern and more 

definitive/extensive health effects testing has not been 

conducted, then the fuel/additive would be required to 

proceed to tier 4. 

Tier 3 requirements would involve short- and 

medium-term health effects testing (i.e., screening, acute 

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P.60 

and subchronic). Depending on the nature of the health 

effects information available from tier 2, the testing in 

tier 3 could be quite comprehensive or limited only to the 

gaps unfilled in tier 2. Tier 3 tests would likely include 

tests for physico/chemical properties, an Ames test, other 

genetic toxicity tests, screening inhalation studies as 

well as any acute and subchronic studies needed to 

determine potential public health effects. EPA requests 

comment on the need for oral and/or dermal vs. inhalation 

studies. Health effects covered include pulmonary 

toxicity, mutagenicity, carcinogenicity, and teratogenicity 

(or toxicological indicators thereof),* and other health 

hazards, if appropriate. Of course, EPA must reserve the 

right to require specific or additional tests for each 

fuel/additive on a case-by-case basis. EPA would 

anticipate that these tests could be completed within the 

previously discussed three-year time period for submitting 

requisite information. 

Individual fuels and additives would proceed into tier 

4 only if the available tier 2 information or tier 3 test 

results were suggestive of an vuiresolved, yet potentially 

significant, health effects concern. Conceptually, tier 4 

tests would be follow-up long-term tests for 

carcinogenicity, mutagenicity, and teratogenicity (and 

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P.61 

other endpoints), and could involve chronic inhalation 

and/or feeding studies among others. Tests would be 

structured to provide adequate toxicological information 

for making risk assessments. Again, raw, combustion, and 

possibly atmospheric transformation products could be 

included. EPA invites comments on the criteria that should 

be included in the guidelines and the process that should 

be used for making individual determinations and developing 

appropriate procedures. EPA is considering adopting many 

of the tests of the TSCA Health Effects Testing Guidelines 

(40 CFR 798) as guidelines under tiers 3 and 4 and asks for 

comment in this area. , 

Thus, tier 3 and 4 testing requirements would apply 

primarily to fuels and additives for which there is 

insufficient information or where the available information 

suggests that the substance may pose an unreasonable risk 

of injury to human health. For example, there are a number 

of current aftermarket fuel additives for which there is 

little publicly available health effects information, and 

future alternative fuels and their additives could also be 

subject to testing if adequate information does not exist 

based on tiers 1 and 2. Depending upon the adequacy of 

existing i tests and the specifications for base 

fuels/additives, this approach to health effects testing 

could substantially reduce the number of fuels/additives 

potentially subject to further testing. 

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P.62 

The four tier program described above has several 

inherent advantages. First, it is a flexible approach 

which focuses on available information regarding health 

effects without requiring arbitrary testing. Second, the 

tiered approach insures that needed testing will be 

accomplished. Third, overall program cost is reduced under 

the tier approach. And, finally, the matrix format set up 

within each tier helps screen false negatives and yield 

more confident results. 

Section 211(b)(2)(A) clearly indicates that 

carcinogenicity, mutagenicity, and teratogenicity is to be 

assessed. However, EPA is allowed some judgment in 

determining what other health effects endpoints should be 

included. EPA asks comment on what other health effects 

endpoints should be included as mandatory, which should be 

applied on an individual basis, and through what procedure 

these determinations should be made. Overall, this program 

approach is intended to: 1) provide an efficient means of 

identifying and summarizing the existing information on the 

health effects of fuels and additives, 2) identifying the 

information gaps, and 3) generating the new information 

needed for regulatory decision making. 

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P.63 

B. Effects on Emission Control Systems 

In addition to a program for health effects, the Act 

also requires the producers/manufacturers to provide the 

information that is "reasonable and necessary" to determine 

the emissions resulting from a fuel or fuel additive and 

the effect of such a fuel or fuel additive on the emission 

control performance of any vehicle or engine. The 

potential scope could include emission speciation for 

regulated and unregulated pollutants as well as effects on 

initial emission rates, emission deterioration rates, 

maintenance requirements, system longevity, and materials. 

Other concerns could include overall general effects on the 

vehicle/engine and emission control system performance. 

EPA invites comments on the extent to which information is 

needed on these effects. 

EPA is contemplating a program design similar to that 

discussed previously for health effects and would again 

primarily utilize a tiered approach with a matrix of 

requirements in some tiers. The principles discussed 

earlier regarding base fuels/additives would also apply 

here. EPA does not anticipate a needlessly broad testing 

program, but would strive to limit any information 

reporting or testing to only those fuels/additives where 

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P.64 

information is needed for regulatory decision making or 

concerns exist over risks to the emission control system 

performance. The tiers envisioned for determining emission 

control system effects are discussed individually below. 

As with tier 1 under the health effects program, this 

initial tier would involve the use of the base 

fuels/additives concept and a showing by the producers that 

their fuels/additives fall within the specifications of one 

of the base fuels/additives. Like under the health effects 

program, for a fuel or additive to be specified as a base 

fuel/additive, adequate existing information must be 

available on the emission control system effects of the 

fuel/additive for regulatory decision making. Assuming 

base fuels/additives are identified, fuels/additives which 

meet the specifications of a base fuel/additive would be 

exempt from testing unless new information needs arise. 

Those products which do not fall under one of the base 

fuels/additives would be required to enter tier 2, since 

the presumption would be that EPA does not now have 

sufficient information on those products for regulatory 

decision making. 

As with the health effects program, EPA asks comment 

on whether adequate emission control system effects 

information currently exists to qualify any particular 

-63-
fuel/additive as a "base fuel/additive" at this time and, 

if not, requests recommendations as to what additional 

information is needed for a candidate fuel/additive to 

qualify. 

Tier 2 would require the producer to submit whatever 

additional information is presently available on the 

emissions or emission control system impacts for the 

fuel/additive under consideration. . This would include a 

literature search for public and in-house engineering 

studies, analyses, and data aimed at determining whether or 

not the fuel or additive showed any potential for adverse 

effects in the areas of concern discussed above. If the 

information submitted was sufficient no testing would be 

required. If, however, the available data was 

insufficient, or the fuel or additive showed potential for 

causing various undesirable effects on emissions, emission 

control system performance, or the vehicle/engine in 

general, then the fuel/additive would have to enter tier 3. 

Requirements and tests under tier 3 would be focused 

on assessing specific concerns raised in tier 2, or just on 

supplying the information lacking from the tier 2 

requirement. This tier could involve any combination or 

-64-
P.66 

form of vehicle/engine tests to provide the needed 

information, but EPA would expect it to be completed within 

the aforementioned three-year time period for submitting 

requisite information. 

EPA invites comment on how this program should be 

implemented and what testing and other information should 

be considered reasonable and necessary. EPA also invites 

comments on what specific tests are appropriate and should 

be included. 

C. Determination of Welfare Impacts 

Under §211(e), the Agency is to issue regulations that 

will implement its authority regarding the assessment of 

welfare effects. CAA subsection 211(b)(2)(B) states that 

the Administrator may require producers to furnish 

information that is "reasonable and necessary" to determine 

the extent to which emissions of fuels and additives affect 

the public health or welfare. The welfare effects 

potentially include all aspects of ecology. This 

assessment could take into consideration the emissions' 

residence time in the air, the fate of the pollutant, and 

what reactions occur with other pollutants in the air, 

including atmospheric transformation products/byproducts 

and deposition effects. 

-65-
P.67 

The Agency is considering using a tiered approach like 

that discussed above in determining welfare effects. 

Fuels/additives to be registered under §211(b)(2) would be 

compared with specifications EPA would develop for "base 

fuels/additives". Again, EPA requests comment on whether 

adequate reasonable and necessary information exists on 

welfare effects to qualify any particular fuel/additive as 

a base fuel/additive at this time and, if not, requests 

specific recommendations as to what additional information 

is needed for a candidate fuel/additive to qualify. 

Producers would be required to submit information to show 

that their fuel/additive meets the specifications defined 

for base fuels/additives. If no fuels/additives qualifying 

as "base fuels/additives" are determined or if this 

information did not show the fuel/additive to be 

essentially the same as a base fuel/additive, then further 

reporting requirements would be necessary. Like tier 2 

discussed earlier, this would involve a thorough literature 

search for existing information and data on known welfare 

effects. In submitting information, producers could be 

required to report the known welfare effects of the raw, 

combustion, and atmospheric transformation products of 

fuels and additives. Such information could be obtained 

from studies, literature searches, reports, summaries of 

existing data and information, and other readily available 

discussion concerning the assessment of welfare effects 

-66-
associated with the use/combustion of fuels and fuel 

additives. This information could then be used to 

determine whether or not the product poses a significant 

hazard to welfare or the environment. If a potentially 

serious welfare threat exists, based on criteria 

established in this rulemaking for making such a 

determination, then further studies, which could be 

included as tier 3 and/or 4, may be required or appropriate 

regulatory action taken. EPA requests comments on this 

approach and on the extent to which the welfare effects 

should be assessed through the submission of information or 

through specific testing requirements. ,The Agency welcomes 

suggestions regarding other appropriate means of assessing 

welfare effects. EPA also asks comment on the 

applicability of the TSCA Environmental Effects Testing 

Guidelines (40 CFR Part 797) to this requirement. 

VI. Statutory Authority 

Authority for the actions proposed in this notice is 

granted to EPA by §211 and §301 (a) of the Clean Air Act as 

amended [42 U.S.C. 7521(a), 7525, and 7601(a); Pub.L. 

95-95]. 

-67-
VII. Administrative Designation and Regulatory Analysis 

Executive Order 12291 states that an Agency must judge 

if a rulemaking would be "major". A rulemaking is 

considered "major" if it will have an annual effect on the 

economy of $100 million or more, if there will be a major 

cost increase for consumers, individual industries, 

federal, state, or local government agencies, or other 

geographic regions, and if there will be significant 

adverse effects on competition, employment, investment, 

productivity, innovation, or on the ability of U.S.-based 

enterprises to compete with foreign-based enterprises in 

domestic or export markets. At this juncture, it has not 

been determined if this action represents a major 

rulemaking. 

VIII. Public Participation 

To aid in preparing the proposed rule, EPA encourages 

full public participation in this action. Comments are 

requested on all aspects of the suggested program and from 

all interested parties. If possible, comments should be 

accompanied by full supporting data (including production 

volume data and complete chemical composition data) and a 

detailed analysis. Parties are encouraged to submit 

information which may not be detailed in the current 

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P.70 

registration database as EPA will be using what information 

is present in supporting analyses for the NPRM. Due to the 

time elapsed, EPA is not considering comments submitted to 

Docket ORD-78-01 for the 1978 ANPRM unless they are 

resubmitted to Docket A-90-07 for this current rulemaking. 

Comments containing proprietary information should be sent 

to the contact person listed above; however, a 

non-confidential version should be sent to the public 

docket if the information is intended to be considered by 

EPA in development of the NPRM. Information covered by a 

claim of confidentiality will be disclosed by EPA only to 

the extent allowed and by the procedures set forth in 40 

CFR Part 2. If no claim of confidentiality accompanies the 

submission when it is received by EPA, it may be made 

available to the public without further notice to the 

commenter. 

EPA desires specific comments on the following 

additional issues regarding this rule: 

l. Health Effects 

a. Should EPA develop test guidelines or, more 

specifically, test plans for purposes of determining health 

effects? 

-69-
P.71 

b. in the event that EPA establishes more than one 

testing plan, should the test plan selected receive prior 

EPA approval? 

c. How should the test plan be organized, tier or 

matrix? 

d. For the four tiers suggested in this notice, 

what should the requirements be? 

e. What other health effects, besides 

carcinogenicity, mutagenicity, and teratogenicity, should 

be considered? 

f. What tests should be required? 

g. What constitutes an acceptable test? 

h. What should be the criteria for determining 

positive and negative test results? 

i. How should the pollutants be administered to the 

host being tested (route of exposure)? 

j. What is the most appropriate grouping scheme for 

fuels and additives and what criteria should be used to 

designate fuels and additives into proper categories? 

k. How should representative fuels or additives 

from within each group be selected? 

1. What criteria should be used to excuse a fuel or 

additive from additional testing based on available 

information? 

m. How should fuel and additive manufacturers 

submit test data? 

-70-
n. On what basis or level of risk should a control 

be established for a fuel or additive? 

o. How could existing guidelines (TSCA, FIFRA, 

OECD, EPA) be applied in this rulemaking? 

2. Emissions Effects Testing 

a. Should EPA develop test guidelines or, more 

specifically, specify test plans for purposes of 

determining emission control system effects? 

b. In the event that EPA establishes more than one 

testing plan, should the test plan selected for use by the 

producer receive prior EPA approval? 

c. How should a program be structured for assessing 

the effects of a fuel or additive on emission control 

system performance? 

d. What tests should be included? 

e. What constitutes an acceptable test? 

f. What criteria should be used to decide if the 

test is positive or negative? 

h. Are there any existing test plans or procedures 

for assessing the performance of emission control systems 

that should be used in this program? 

i. What procedures should be used for sampling 

unregulated emissions? 

-71-
j. What portion of the exhaust should be collected 

and measured (i.e., whole exhaust, fractionated exhaust, 

irradiated whole or fractionated samples)? 

k. What driving cycles should be part of a testing 

program? 

1. How many miles should an engine/vehicle be 

driven for each tier of testing? 

m. Should evaporative and refueling emissions be, 

sampled? 

n. Should running losses be sampled? 

o. How should manufacturers submit test data? 

p. On what basis shall fuels* and additives be 

controlled or banned? 

3. Other Matters 

a. What welfare effects should be assessed and how 

should this be accomplished? 

b. Besides grouping fuels and additives that are 

essentially the same, what other means are there for 

minimizing duplicative testing? 

c. What measures should be implemented to allow for 

cost- and/or burden-sharing between manufacturers? 

-72-
P.74 

d. What criteria should be used to determine if a 

fuel or additive manufacturer is a small business? 

e. If volume and sales levels are used to define 

small business, what levels should these be set at? 

f. Should a manufacturer be excused from health 

effects and emission testing where it can demonstrate that 

the fuel or fuel additive in question will not cause an 

adverse health effect or affect emission control device 

performance? If so, what should EPA require from the 

manufacturer to make such a showing? Should EPA develop 

» 

screening test requirements as part of this rulemaking as 

outlined earlier? 

g. What factors should be included in any 

enforcement program? 

-73-
_ P.75 

IU:HNN HKbUK '' " ' 

PUG-02-'90 THU 06:58 ID:OMS W901 TH_NQ:202/245-373B .. . 8172 P02 

List 0% Subjects in 40 CFR Part 79 

Fuel, Fuel Additives, Gasoline/ Gasoline Additives, Diesel/ 

Diesel Additives/ Health and welfare Effects, Emission 

Control Systems/ Motor Vehicle Pollution, Penalties, 

Administrative Practices and Procedures. 

Dated: AUG 0 1 

JM JUU»A~S 

William K. 

Administrator 

-74-