P.1 

OAR Box 1165 

Prepped by Ollie Stewart 

Document Number: 

257) F. R. August 7, 1990 

Docket Number: 

A-90-07 

Printed 4/28/2008 11:52:23 AM Sheet 257 of 257 
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Tuesday 

August 7, 1990 

Us 

Part VI 

Environmental 

Protection Agency 

40 CFR Part 79 

Fuels and Fuel Additives Registration; 

Advance Notice of Proposed Rulemaking 
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32218 Federal Register / Vol. 55, No. 152 / Tuesday, August 7.1990 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 79 

(FRL-3811-21 

RIN 2060-AC10 

Fuels and Fuel Additives Registration 

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 section 211 (b) and (e) of 

the Clean Air Act The regulations are to 

provide for tests to determine potential 

pubUc 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 section 211. By 

law, the regulations may also 

incorporate small business and cost 

sharing provisions and provisions to 

guard against duplicative testing. 

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 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-1500,401M 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 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. 

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 die hearing for scheduling 

the order of testimony. It 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 widi die 

court reporter recording the proceedings. 

n. Introduction 

EPA is announcing its plans to 

implement its statutory authority tQ 

assess the effects of motor vehicle fuels 

and fuel additives on the pubhc 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 whemer any limits are 

needed on fuels and additives under the 

statutory criteria in section 211(c). 

EPA has recendy 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 pubhc 

health, welfare, and emission control 

system effects of fuels and fuel 

additives. 

This Advance Notice is organized to 

highlight topic areas and issues diat 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 horn die public, die 

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 widi an invitation for public 

participation and a detailed list of 

questions and issues on which EPA 

desires comment 

HI. 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 

(Pubhc Law 91-604. December 31,1970) 

to require certain tests and other 

information before registration of fuels 

and additives. More specifically, section 

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, section 

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. 

Almough die general registration 

regulations were implemented in 1975, 

EPA did not implement the discretionary 

authority to require health, welfare, and 

emission control system effects testing 
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a: ©MB 

/ VoL .55, No. 152 / Tuesday, August 7, 1S30 / Proposed Rules 

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under section 211(b)(2) or establish 

procedures and protocols for these tests. 

In the CAA Amendments of 1977, 

Congress added a requirement to 

section 211 (Public Law 95-95, August 7, 

1977). This requirement, codified at 

section 211(e), mandates that the 

Administrator implement the section 

211(b)(2) authority and provides 

additional discretion concerning the 

implementation of the section 211(b)(2) 

testing requirements. 

Section 211(e)(1) requires 

implementation of the section 211(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 

section 211(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 section 

211(b)(2) regulations. Section 211(e)(3) 

allows the Administrator fo exempt or 

make special exceptions for any small 

business, fo provide for cost and/or 

burden sharing with respect to any fuel 

or additive manufactured by two or 

more entities, and fo exempt any person 

from such regulations where additional 

testing would be duplicative of adequate 

existing testing. 

In an effort to fulfill the section 

211(e)(1) requirement that regulations be 

promulgated within one year, EPA 

pubhshed 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 section 211(b) testing 

requirements were not implemented 

when required, there have been other 

efforts related fo fuels and additives 

over the past ten years. The fuel and 

fuel additives registration program is 

currendy operative. Section 211(f) and 

the EPA interpretive rule on 

"substantially similar" fuels (46 FR 

38582-38586; July 28.1981) have served 

fo control the market entry place of fuels 

and direct additives absent a waiver 

under section 211(f)(4). Also, EPA's 

Draft Alternative Fuels Research 

Strategy provides broad direction 

concerning the research needed fo 

assess the potential relative public 

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 

adverse effects of fuels and additives. A 

list of many of the reports published in 

this area can be found in Docket No. A80-07. Thus, while the required section 

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 section 211 of the Toxic 

Substances Control Act (TSCA), 15 

U.S.C 2820, requested the Agency to 

initiate a rulemaking under section 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 section 211 of die CAA and 

section <3 of TSCA to consider health 

and environmental effects testing of all 

motor vehicle fuels including fuels 

currendy in use and those undergoing 

development 

Second, a citizens group brought a 

lawsuit challenging EPA's failure to 

promulgate regulations within the oneyear period provided for in CAA section 

211(e). Thomas v. aHeilly, CA. No. 89-

6269 (D. Oreg. 1989). EPA has entered 

into a Consent Decree in setdemenf of 

this lawsuit without the adjudication of 

any issue of fact or law, and the Decree 

has been signed by the Court Under the 

Decree, the EPA Administrator is fo sign 

a Notice of Proposed Rulemaking for 

publication in the Federal legists? by 

January 1.1992, and to sign a Final Rule 

by June 1,1993. By its terms, the Consent 

Decree "is not addressed to the 

substance of the rulemaking" and 

nothing in if is fo be construed "to limit 

or modify the discretion accorded ° ° ° 

by section 211 '"o r general principles 

of administrative law in any fashion". 

IV. Fuel and Fuel Additive Program 

Design and Hmplementatioini Issues 

A. Introduction 

The CAA requirements clearly 

indicate diat die fuel and fuel additive 

program provided for in section 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. 

The statutory provisions governing the 

fuel and fuel additive program were 

discussed above. In summary, section 

211(b)(2)(A) requires testing to 

determine potential public health effects 

of the fuels and fuel additives 

themselves. In addition, section 

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 pubhc health 

and welfare. Furthermore, section 

211(e)(2) requires the "requisite 

information" for registration to be 

supplied to EPA within certain time 

limits and section 211(e)(3) includes 

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 activeregistered 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 registered when the 

section 211(e)(1) requirement was 

established and, as discussed below, 

these are expected fo grow in number in 

the future. To require all of the 

approximately 8000 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 pubhc 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 
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32220 Federal Register / Vol. 55. No. 152 / Tuesday. August 7.1990 / Proposed Rules 

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 the rule 

is promulgated. In some cases, 

especially in chronic testing, it may not 

be possible to obtain accurate and 

conclusive results witiiin the prescribed 

time specified by the Act. 

Third, health, welfare, and emission 

control system impact testing is costiy to 

administer and conduct on a case-bycase 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 thet at present Gfcesre are only a 

relatively limited nnamber of tsst 

laboratories capable off ©tradirccting such 

testing and ©the? erahaltaas, and fuel 

and feel QddittwEs wos& CTO^M not be 

the ©nly Hype of testtag tossing handled at 

these ffatibiiec. In add-Mcsa, testing for 

atmospheric transformation products 

and dfaeir impact cm air quality and 

health <pftw*n may precaaS an even 

greater difficulty in this area. 

The statatary mparega-anto and 

practical ctrasteaiato psresesat what may 

appear to bs a conflict between the 

goals and She means of achieving them. 

The statute calls for health, welfare, and 

emisskm eyetem impact testing to be 

done and provides a specified time 

frame fo? submitting information widi 

due consideration to bs given to cost 

and undue burdens. A review of die 

practical Sectors suggests that this could 

be difScaalt since the fuel and fuel 

additive popuation is large, tests are 

time mnirnainiiing, costiy and sometimes 

mccodusihre, and laboratories and other 

facilities capable of doing the testing are 

limited is mumber. 

The otatutory mandate and its 

legislative histosy garmde for oome 

measures that help alleviate the burden. 

As discussed above, the otatute contains 

provisions for cost-charing and nonduplicatiwe testing, as well as a small 

business exemption. Pursuant to the 

applicable legislative history, costs and 

the prevention of undue burdens are to 

taken into account in developing the test 

requirements. Moreover, "relatively 

inexpensive but reliable test methods" 

are to be rased "insofar as possible." 

H.R. Rept 65-294.85th Cong. 1st Sess. 

309 (1977). The statute also relies on 

EPA's judgment'in establishing the test 

program. With respect to the tirning of 

data submission, EPA has discussed 

below a number of options which could 

provide additional time for testing when 

more time is needed. 

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 will be 

important to make appropriate use of 

the section 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 widi 

present fuels and additives must be 

taken into account 

The remainder of this section of the 

notice discusses come of the key 

program design and implementation 

issues in more detail. This includes more 

detailed discussioas, analyses, and 

requests for comment oa boih ths 

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 

additivea are the only designated fuels 

and additives for purposes of 

registration (See 40 CH. part 79). There 

are currendy approximately 2240 activeregistered fuels and 37S0 activeregistered 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 

covering gasoline and diesel fuels. 

Given die 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 heir 

additives for registration. (55 FR 16876, 

April 23.1990) This could include: 

methanol, ethanol, or any other motor 

vehicle alcohol fuel', liquified 

petroleum gas, and compressed natural 

gas. These changes would expand Uie 

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 section 211(e)(3) of the Act Section 

211(e)(3)(A) provides for special 

requirements for small business. 

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

burden sharing for a fuel/additive 

produced by more man one person. 

Finally, section 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 approaches, such as tiered 

requirements, the use of non-animal test 

systems where appropriate, and die 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 fo exempt or 

' Alcohol fuel would likely be defined aa a motor 

vehicle fuel containing ot least SO percent alcohol by 

volume. Mixtures d alcoStolo caxd fjoooliitso tvcmld 

likely ks registered oa a gaoolins if ths alcohol 

content was less than SO percent 
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F(s<fl®ral Iftaglisteir / VoL 55, No. 152 / Tuesday, August 7,1SS0 / Proposed Rules 

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 as part of this definition. In 

addition, the toxicity or potential risk of 

the fuel or fuel additive may be taken 

info consideration. While sales/revenue 

may be more appropriate fo 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 fo assessing the potential risks to 

the pubhc health, welfare, and emission 

control system performance. EPA 

requests comment on what sales/ 

revenue tiiresholds 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 section 26 

(40 CM 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 

section 5 notice, when combined with 

those of the parent company (if any), are 

less than $40 million. A similar 

definition is used for TSCA section 8 

reporting rules (40 CFR 704.3). EPA 

requests comment on the applicability of 

these definitions fo 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 information 

is essential if EPA is fo 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 section 211(e)(3)(B) 

provide a means fo reduce the cost and 

burden of die 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 

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 discussed 

below. However, the concept of 

grouping for testing purposes has section 

211(b)(2) implications with regard to 

EPA's approach to implementing 

protocols, so if will be discussed in a 

separate section. 

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 fo 

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 die same testing 

requirements prior fo 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 manufacturers of the same 

fuel or additive to share the 

responsibilities of complying with the 

testing regulations. To implement this 

authority in the first case, the 

manufacturer who conducts tests of a 

product would be recognized under 

section 211(e)(3)(B) as having a right to 

cost-sharing from others who wish to 

reply on that testing for purposes of 

section 211. These other manufacturers 

would not be able to use the first 

manufacturer's test results witiiout 

reaching an agreement on sharing die 

cost The Agency invites comment on 

whether the provisions should be 

applicable to provide for cost-sharing 

when one manufacturer has submitted 

test results tiiat 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 diat 

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 section 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 

tests are a number of years old? Should 

the reimbursement provisions of section 

4 of TSCA be considered a model for 

handling cost-sharing questions? 

EPA has extensive experience under 

TSCA section 4 with cost-sharing for 

testing. EPA has found that persons 

conducting testing under section 4 have 

chosen in each instance to date to work 

out their own arrangements for costsharing 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 die regulations. 

EPA solicits comment on whether a 

similar result is likely under the section 

211 testing program. 

3. Grouping of Fuels and Additives for 

Testing 

As was mentioned above, to 

implement the section 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 deterniining potential 

pubhc 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 section 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 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 
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32222 Federal Register / Vol. 55, No. 152 / Tuesday, August 7.1990 / Proposed Rules 

undergo die 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 die 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 mis approach, 

several representatives of the group 

might be oubject 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. "Analysis of Aftermarket 

Fuel Additives Containing Methanol" 

(available in Docket No. A-SO-07), 

shows that a large number of die 

aftermarket fuel additives considered 

contain almost all methanol; however, 

there is a small portion that contains a 

large number of other compounds as 

well Sn trying to group these additives 

on the basis of an "essentially the same" 

defajtoois 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 than would have to 

be tested. 

The provisions of CAA section 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. Sn a 1981 Interpretive Rule (46 

FR 38582-38588; 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 Hmitation 

on type of alcohol), with ftiel 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 die 

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 SOT testing. The results of 

an analysis to bs 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 die 

criteria to bs 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. 

4. Duplicative and Existing Tests 

Under CAA section 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 section 

211(c)(2)(A), the Administrator can only 

control or regulate a fuel on die basis of 

all relevant medical and scientific 

evidence available to him. 

To structure the testing program and 

to determine if there is duplicative 

testing, if is important fo obtain results 

from existing tests on fuel and fuel 

additives at an early point If is also 

necessary to determine what testing has 

been initiated. Since it typically fakes 

several years for a report fo be made 

public to avoid unnecessary 

duplication, it is important fo 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 part 79, subpart D 

(implemented emder section 2tl{bXl)). 

to ensure that producers provide a 

summary of any published testing 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 section 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 die 

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 section 

211(b)(2). 

EPA sees diis 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 2M(b)(2) provides that tests 

are to be conducted according to test 

procedures and protocols established by 

the Administrator. The section could be 

read as simply requiring adherence fo 

specific guidelines identified by EPA, 

ra tiler than requiring EPA to establish 

specific test plans or procedures in 

every case before testing is done. EPA 

might provide for die 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-bycase 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 

currendy 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 Ac*. 
P.8 

Fedmid Register i Vol 55, N a 152/Tuesday. August 7.1990 / Proposed Rales • ^^-^ftfl 

1 

:??• 

1. Existing Hearth 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 Insecticide, Fnrrgicide, and 

Roderrtfcide Act (FIFRA) Toxicology 

Data Requirements (40 CFR 158.340), 

and the Organization for Ecrmornic 

Cooperation and Development (OECD) 

Guidelines for Testing of Chemicals.* 

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.*, *, *, • 

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 far the evaluation of health 

and environmental hazards of a 

chemical. The health effects that are 

indnded are primarily acute, 

subchronic, and chronic toxicology 

(dermal, oral and inhalation) as well as 

oncogenicity end genetic toxicology. 

These protocols provide guidance and 

to a varying degree details on 

acceptable models of testing design, bat 

more specific guidance may be needed 

in particular cases. However, the 

potential scope cf die fuel and fuel 

additive testing program is sach 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 

» "OECD Guidelines for Testing of Chemicals": 

ISBN 92-64-12900-6:1981. 

9

 "Possible Approaches to the Health Effects 

Testing of Fuels and Fue! Additives": Litton 

Bionetics. Inc.: Technical Directive No. 008. EPA 

Contract No. 88-02-3682: Draft Report July 1983. 

4

 "Use of Short-Term Genotoxir, Bioaways in the 

Evaluation of Unregulated Automobile Emissions": 

Litton Bionetics. Inc: EPA Contract Na 68-02-3682: 

Final Report October. 1983. 

• "Validation of Chemical and Biological 

Techniques for Evaluation of Vapors in Ambient 

Air/Mutagenicity Testing of Twelve (12) VaporPhase Compounds": EPA Contract No. 68-02-3170-

082 EPA-600/1-64-005; March. 1984. 

* "Testing for Heaith Effects of Fuels and Fuel 

Additiws"; Southwest Foundation for Research and 

Education: EPA Contract No. 68-02-2288: Draft 

Report 197a 

approval as is presently used by EPA in 

its TSCA section 4 test rule for drbenzopara-moxms/dibenzofurarM (40 CFR 

part 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 retestihg 

if unacceptable. 

Because of the number of fuels/ 

additives that could be tested, it is 

desirable, if possible, to have model 

guidelines thai 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 the 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 conibustian 

products of fuels and fuel additives? 

What procedures should EPA use for 

protocol review and at what point 

should these reviews occur if needed? 

In addition to the health effects testing 

guidelines, EPA has also issued five 

risks assessment guidelines: (1) 

"Guidelines far Carcinogen Ride 

Assessment" (51 FR 33992-34003. 

September 24.1986); (2) "Guidelines for 

Mrkagenicity Risk Assessment" (51 FR 

34008-34012. September 24.1986): (3) 

"Guidelines for the Health Risk 

Assessment of Chemical Mixtures" (51 

FR 34014-34025, September 24.1986); (4) 

"Guidrfrnfisfcr 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: (1) 

"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, 

1988h (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 section 211(b)(2). 

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 nmnber 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. Far example, the 

EPA staff is aware of only 

approximately three faculties capable at 

present of conducting inhalation studies 

with vehicular combustion emissions. 

EPA especially invites comment from 

the scientific community an 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 die docket when completed. 

3. Hearth Effects Endpoints 

As discussed earlier, the CAA 

provides for tbe Administrator to require 

testing to determine potential public 

health effects indnrrrng carcinogenicity, 

mutagenicity, and teratogenicity. Testing 

is not necessarily to be limited to tiiese 

health effects but. rather, may include 

testing for systemic toxicity, 

cardiovascular and inhalation fffw^s, 

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 

if. 
P.9 

32224 Federal Register / Vol. 55, No. 152 / Tuesday, August 7. 1990 / Proposed Rules 

causes contact with the raw fuel or 

additive. 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 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 the 

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 section 4 of TSCA testing of 

chemicals to develop data is required if 

the Administrator makes certain 

findings as described in TSCA section 

4(a)(1) (A) or (B). In TSCA section 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 section 5, EPA screens 

new chemical substances before 

manufacture is permitted to assess their 

potential to cause injury to human 

health or die environment Using 

findings similar to those under TSCA 

section 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 the chemical or the 

substance may reasonably be 

anticipated to enter the environment in 

substantial quantities. 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 section 211(e) 

indicates that EPA should use relatively 

inexpensive but reliable test methods 

insofar as possible. H-R. RepL 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 section 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 

Requirements 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 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". HR. Rept No. 95-294, 

95th Cong. 1st Sess. 309 (1977). The 

House Committee also expected EPA to 

utilize as far as possible the "[relatively 

inexpensive but reliable test methods" 

which are becoming "increasingly 

available". The "paramount interest" in 

protecting the pubhc health requires test 

protocols which are "reasonably 

comprehensive" with respect to a 

number of health effects. Ibid. 

As was discussed above, there 

appears to be some tension between the 

full potential scope of the testing 

requirement of section 211 and the 

Congressional goal that the 

implementing regulations not be "unduly 

burdensome". Special difficulties can 

arise if comprehensive testing of 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. Longterm 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. 

* "Health Assessment Document for Diesel 

Emissions;" Office of Research and Development 

U.S. Environmental Protection Agency; Draft 

Report May 25,1990. 
P.10 

¥mdm.Ma^st«tJVel.SS, N a 152 / Tuesday, Augnst 7, fflW / fwtpoaesl Rde« 

V! 

i 

As discussed above, a three-year time 

period to complete any required testing 

would also strain the presently 

available laboratory griffta— far 

conducting studies, particulariy 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 iirrpractical 

to complete oil testing of all fuels and 

fuel additives within three years. 

It should be emphasized that at this 

point much remains to be learned about 

the extent of tbe 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, er on 

whether there are alternative 

approaches that should be considered. 

1. Requisite Information 

One approach, which appears sound 

and consistent with the Act would be to 

view the requirement in section 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 section 211(e)(2) refers to the 

submission of "requisite information" 

required by regulation to implement the 

authority under section 211(b). The 

authority under section 211(b) that EPA 

is required to implement by section 

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 

section 211(e) no longer leaves EPA any 

discretion on whether to nnpleraent 

section 211(b), subsection (b) relies on 

EPA to exercise judgment in determining 

the testing needed to meet the statutory 

aims. 

In the regulations rmplemerrting 

section 211(b). EPA would exercise its 

judgment to establish a fuel and fuel 

additives program that will meet the 

testing requirements 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 diat 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 

section 211(b)(3) which provides that 

registrants will give assurances that 

they will submit additional information 

which reflects "changes in the 

information required" for registration. 

Furthermore, as discussed above in 

connection with the methanol petition, 

die Agency also has the option to use its 

authority under TSCA in conjunction 

with section 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 dian the three 

years. 

2. Three-Year Test Period 

Another possibility is that the 

requirement in section 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 (he use of tests diat 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 infannation can 

also help the Agency make a 

preliminary assessment of the potential 

for public health, emission control and 

welfare effects. The information can 

guide the Agency's decision making and 

help to identify the need far farther 

testing. If studies take longer than three 

years to complete, they would not be 

subject to the section 211(e) 

requirement If additional testing is 

required, the Agency could use its 

authority under TSCA to require the 

submission of completed .tomes. 

Moreover, section 211(b)(2) and (3) can 

be viewed as arrthority trader which die 

Agency can continue to reqtnre 

additional testing whenever needed 

even if the tests cannot be completed in 

the three year period identified in 

section 2Hfel 

3. Enforcement Discretion 

While perhaps not prefered, another 

approach would recognize that while 

section 211 requires the submission of 

all requisite information within three 

years, die Agency has discretion in 

taking enforcement action. The Agency 

could issue guidelines that would 

recognize that absent unnsnal 

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 widi the 

greatest-potential for extensive adverse 

effects. See Heckler v. Chaney. 470 U.S. 

821 (1985), and Cutler v. Hayes. 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 
3222® Federal Register / Vol. 55, No. 152 / Tuesday, August 7, 1990 / Proposed Rules 

essentially the same as a registered fuel 

or additive for which testing is still 

ongoing, should a temporary registration 

ever be available for die 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 section. 

211. EPA is still in the process of 

developing its regulatory approach, and 

is interested in suggestions for any other 

approaches that should be considered. 

F. OUier i°wgram 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 fo 

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 Requirements 

Any testing program that is developed 

will entail some degree of reporting. 

Exacdy how much and in what form this 

information should be submitted needs 

to be established. Currendy, 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 fo 

EPA on a standard form. With respect to 

die additional! information that mil need 

to be provided omos testing regulations 

are promulgated, how shall this 

information bs 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 peerreviewed 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 

testing or regulatory action is needed. 

One value of die testing program is the 

information it provides to the decisionmaking process. In addition, section 

211(c) provides that, based on the 

information obtained under section 

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 die 

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 

section 211(c)(1)(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 dial was less dangerous 

to the pubhc 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 system. 

EPA invites comment on the appropriate 

process if should use to evaluate test 

results submitted under section 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 section 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 die fuel or additive was 

necessary, it would commence 

rulemaking under section 211(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 section 211(b). 

An alternative approach would be for 

EPA to establish a forma! 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. 

Comment is invited on whether the 

Agency should establish a formal 

review process fo 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. 

4. Consequences of Failure to Submit 

Requisite Information 

When the section 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 section 211. Under 

section 211(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 section 211(e), a 

new fuel or fuel additive is fo 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 section 211(e) 

suggests that if the requisite information 

is not submitted within three years for 

registered fuels and additives the 

Agency's regulations "should provide 

that such .registration shall be deemed to 

be revoked". RR. Rept No. 95-284,95th 

Cong., let Sess. 308 (1877), This 

provision can be viewed as authorizing 
P. 12 

w 

r 

regulations that provide for revocation 

when the requisite Information is not 

provided. K 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. 

Lastiy, EPA invites comment on the 

consequences diat 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 pubhc health or welfare or to an 

emission control system. One possibility 

is fo view section 211(b) as implicitly 

authorizing denial of registration when 

an unacceptable risk is shown. Another 

alternative is to view section 211(b) 

solely as an information-gathering 

provision with section 211(c) governing 

risk-based regulatory actions. Under this 

approach, the procedures and criteria of 

section 211(c) would have to be used if 

the Agency wished to deny registration 

based on nature of the risks shown by -

the tests or information submitted for 

registration. If section 211(c) is the basis 

for regulating a risk, may the Agency 

deny registration while a proposed 

regulation under section 211(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 fo yield the 

information needed to determine 

whether or not the product may cause 

the health effects of concern. This 

includes a 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 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 mat 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 fo 

complete the tiers needed fo 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 pubhc health effects for 

regulatory decision making. (EPA 

specifically requests comment on 

whether adequate health effects testing 

information currently exists fo 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. 

As noted above, EPA has included in 

Docket No. A-SO-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 section 

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 chemical composif.es. 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 fo fall within the 

specifications for a base fuel/additive, 

the presumption would be that EPA 

does not now have sufficient 

information for regulatosy 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 die fuel/additive. This 

would cover information on all of the 

human health effects of 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 section 

211(b)(2)(A). As part of this tier, a . 

producer would make any request for a 

finding under section 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. 

SE-
P.13 

32228 Federal Register / Vol. 55, No. 152 / Tuesday, August 7, 1990 / Proposed Rules 

Tier 3 requirements would involve 

short- and medium-term health effects 

testing (eg., screening, acute 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 io 

determine potential public health 

effects.^PA requests comment on the 

need for oral arid/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 teste 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 

v. ere suggestive of an unresolved, yet 

potentially significant health effects 

concern. Conceptually, tier 4 tests would 

be follow-up long-term tests for 

carcinogenicity, mutagenicity, and 

teratogenicity (and other endpoints). 

and could involve chronic inhalation 

and/or feeding studies among others. 

Testa 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 indiviudal 

determinations and developing 

appropriate procedures. EPA is 

considering adopting many of the tests 

of the TSCA Health Effects Testing 

Guidelines (40 CFR part 798) as 

guidelines under tiers 3 and 4 and asks 

feu* comment in this area. 

That, tier S 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 far which there is Utile 

pubfidy available health effecte 

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 adequacy of existing 

tests and die specifications for base 

fuels/additives, this approach to health 

effects testing could substantially 

reduce the number of fuels/additives 

potentially subject to further testing. 

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 

negative 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 detenmhing 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. 

B. Effects on Emission Control Systems 

In addition to a program for health 

effects, the Act also requires die 

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 specdatitm 

for regulated and unregulated pollutants 

as well as effects on initial emission 

rates, emission deterioration rates, 

maintenance reqwreraenta, 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 ef requirements in aome 

tiers. The principles discussed earner 

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 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 tbe 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 far 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 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 tbe vehicle/engine in 

general, then the fuel/additive would 

have to enter tier a 
.P..14 

mi 

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Fsdfflffffll a®giste / Vol. 55, No. 152 / Tuesday, August 7,1990 / Proposed Rules 

3 

11 

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 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 section 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. 

The Agency is considering using a 

tiered approach like that discussed 

above in determining welfare effects. 

Fuels/additives to be registered under 

section 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 die 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 hterature 

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 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 

VL Statutory Authority 

Authority for the actions proposed in 

this notice is granted to EPA by sections 

211 and 301(a) of the Clean Air Act as 

amended (42 U.S.C. 7521(a), 7525, and 

7601(a); Pubhc Law 95-95). 

VU. 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. 

Vffl. Public Participation 

To aid in preparing the proposed rule, 

EPA encourages full pubhc participation 

in this aciton. 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 

registration data base 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-S0-07 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 pubhc 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 fo the 

extent allowed and by die procedures 

set forth in 40 CFR Part 2. If no claims of 

confidentiality accompanies the 

submission when it is received by EPA 

it may be made available to die pubhc 

without further notice to the commenter. 

EPA desires specific comments on the 

following additional issues regarding 

this rule: 

1. Health Effects 

a. Should EPA develop test guidelines 

or, more specifically, test plans for 

purposes of determining health effects? 

b. In the event that EPA establishes 

more than one testing plan, should the 

test plan selected receive prior EPA 

approval? 

a 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? 
P.15 

32230 Federal Register / Vol. 55, No. 152 / Tuesday, August 7,1990 / Proposed Rules 

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? 

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 app!ied 

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? 

a How should a program be 

structured for assessing tbe 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? 

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 diis 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? 

d. What criteria shook] be used to 

determine if a fuel or additive 

manufacturer is a small business? 

e. If volume and sales levels are used 

to define smalt 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 outliend eariier? 

g. What factors should be included in 

any enforcement program? 

List of Subjects in 40 CFR Part 79 

Administrative practices and 

procedures, Diesel, Diesel additives. 

Emission control systems. Fuel Fuel -

additives, Gasohne. Gasoline additives. 

Health and welfare effects. Motor 

vehicle pollution. Penalties. 

Dated: August t, 1990. 

VVUliam K. Reilly, 

Administrator. 

(FR Doc. 90-18452 Filed 8-6-80; 8:45 am) 

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