p.1 

OAR Box 1868 

Prepped by Ollie Stewart 

Document Number: 

12) VII-A-1 

Docket Number: 

A-90-07 

Printed 11/26/2008 8:35:12 AM Sheet 12 of 258 
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U-cif-i ENVIRONMENTAL PROTECTION AGENCY 

40 CPR Part 79 

[FRL - 4^ ^ ] 

Registration of Fuels and Fuel Additives: Changes in 

Requirements, and Applicability to Blenders of Deposit Control 

Gasoline Additives 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Proposed Rule. \ 

\^\^m*Saa -*. „ 

. »»_•_•_- ! m __rr-^OUJ-.r^y. 

SUMMARY: Thiliss 1 I notic notiee^^ proposes several specific changes to 

regulations requiring the registration and testing of designated 

motor vehicle fuels and fuel additives (F/FAs) by their 

manufacturers. The objectives are to reduce the number of 

respondents, streamline program requirements, further ease small 

business burdens, and clarify some specific technical provisions in 

the existing registration regulations. Included in the proposed 

group of respondents no longer required to be registered as fuel 

manufacturers are those who solely blend deposit control additives 

into gaso1ine. 

DATES: Written comments on the issues presented in this notigoO^ 

days after publication date].

 v<^ 

ADDRESSES: Comments should be sent in duplicate to EPA Air 

Docket Section (LE-131); Attention: Public Docket No. A-90-07; 
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Room M-1500, 401 M Street S.W., Washington, DC 20460; Phone 202-

260-7548 or 7549; FAX 202-260-4000. The docket is open for public 

inspection from 8:00 a.m. until 5:30 p.m., Monday through Friday, 

except on government holidays. Previous rulemaking documents and. 

other materials related to this proposal are available in the 

docket. As provided in 40 CFR part 2, a reasonable fee may be 

i 

charged by EPA for photocopying services. 

POR FURTHER INFORMATION CONTACT: Jim Caldwell (202-233-9303) or 

Joseph Fernandes (202-233-9016), U.S. EPA, Office of Mobile 

Sources, Fuels and Energy Division, Mail Code 6406J, 401 M Street 

SW, Washington, DC 20460. 

Electronic copies of this proposed rule, the regulatory text 

for this proposed rule, and earlier rulemaking documents related to 

the F/FA Registration Program are available free of charge on EPA's 

Technology Transfer Network Bulletin Board System (TTNBBS). For 

specific instructions, contact Joseph Fernandes at the phone number 

or address above. These documents are also available in the public 

docket referenced above. 

SUPPLEMENTARY INFORMATION: 

I. Regulated Entities 

Regulated categories and entities potentially affected by this 

action include: 
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'Cateaory 

Industry 

v 

• - • • 

Examples of reoulated entities 

Manufacturers of gasoline and 

diesel fuel. 

Manufacturers of additives for 

gasoline and diesel fuel. 

This table is not intended to be exhaustive, but rather 

provides a guide for readers regarding entities likely to be 

regulated by this action. This table lists the types of entities 

that EPA is now aware could be potentially regulated by this 

action. Other types of entities not listed in the table could also 

be regulated. To determine whether your entity would be regulated 

by this action, you should carefully examine this preamble and the 

proposed changes to the regulatory text. You should also carefully 

examine the existing provisions of the registration program at 40 

CFR part 79. 

II. Introduction 

A. Background 

The F/FA registration program is authorized by section 211 of 

the Clean Air Act (CAA) and codified in 40 CFR part 79. In 

accordance with CAA sections 211(a) and (b)(1), basic registration 

requirements applicable to gasoline and diesel fuels and their 

additives were issued in 1975. These regulations require 

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manufacturers to submit information on their F/FA products, such as 

a 

the commercial identity, chemical composition, purpose-in-use, and 

range of concentration, in order to have such products registered 

by the EPA. 

Additional registration requirements, implementing sections 

211(b)(2) and (e) , were proposed in April 1992 and February 1994 

(57 FR 13168 and 59 FR 8886, respectively) and were finalized on 

May 27, 1994 (59 FR 33042, June 27, 1994). The additional 

regulations require manufacturers, as part of their F/FA 

registration responsibilities, to conduct tests and submit 

information on the health effects of their F/FA products. These 

requirements are organized within three tiers. Tier 1 requires 

analysis of the combustion and evaporative emissions of F/FAs and 

a survey of existing scientific information on the public health 

and welfare effects of these emissions. To the extent that 

adequate test data are not already available (as defined in the 

regulations), Tier 2 requires manufacturers to conduct specified 

toxicology tests to screen for potential adverse health effects of 

the F/FA emissions. Under Tier 3, follow-up testing may be 

required at EPA's discretion, to further evaluate concerns 

identified in the earlier tiers. 

The ruls also .'rcludes several provisions to reduce the 

,information collection and testing burdens. Among these provisions 

is a voluntary grouping and cost sharing program which allows 

manufacturers of similar F/FAs to pool their resources and efforts 

in complying with the requirements. Special provisions for small 
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manufacturers are also included. 

In subsequent sections of this notice, EPA proposes several 

specific changes to the F/FA registration regulations. These 

proposals would not impact the overall structure nor (with minor 

exceptions) the scientific requirements of the current program. 

Rather, EPA is proposing tb revise and/or add certain definitions" 

and provisions, with the intended result of decreasing or, in some 

cases,, removing the requirements altogether for many F/FA 

registration respondents. EPA believes that the proposed changes 

would significantly reduce the overall burdens of the F/FA 

registration program without having an appreciable impact on its 

monitoring, control, and information collection objectives. 

B. Public Participation 

EPA desires full public participation in arriving at its final 

decisions and solicits comments focused specifically on the 

proposals in this notice. Wherever applicable, full supporting 

data and detailed analysis should be submitted to allow maximum use 

of the comments. Written materials already submitted in regard to 

the issues addressed by these proposals will be fully considered by 

EPA, and need not be resubmitted in response to this notice. At 

this time, EPA is not seeking comments on issues other than those 

specifically addressed in this notice, and is under no obligation 

to respond to any such comments it may receive. EPA is not 

planning to hold a public hearing on this proposed rule. However, 

a hearing will be held if requested within 10 days after 

publication. Requests for a public hearing should be submitted in 
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writing to Joseph Fernandes at the address provided above. 

Any proprietary information being submitted for the Agency's 

consideration should be markedly distinguished from other submittal 

information and clearly labeled "Confidential Business 

Information." Proprietary information should be sent directly to 

the contact persons listed above, and not to the public docket, to 

ensure that it is not placed in the docket. Information thus 

labeled and directed shall be covered by a claim of confidentially 

and will be disclosed by EPA only to the extent allowed and by the 

procedures set forth in 40 CFI*< Part 2. 

If no claim of confidentiality accompanies a submission when 

it is received by EPA, it may be made available to the public 

without further notice to the commenter. 

III. Fuel Manufacturer and Additive Definitions 

A. Background 

Section 211(a) of the Clean Air Act authorizes EPA to 

designate fuels and fuel additives, and prohibits manufacturers or 

processors of designated fuels ani additives from introducing them 

into commerce without having them registered. Section 211(b) 

describes the registration renui'-ement for designated fuels and 

fuel additives. Pursuant to § 211(b)(1), the manufacturer of any 

designated fuel or additive must provide EPA with certain 

identifying information about the fuel or additive to obtain 

registration. Section 211(b)(2) provides EPA with discretionary 

authority to require health effects testing information from 
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manufacturers of designated fuels and additives for the purpose of 

registration. 

In the 1977 amendments to the Clean Air Act, Congress included 

a provision that directed EPA to issue regulations to implement S 

211(b)(2). These regulations were issued in May 1994, and included 

an amendment to EPA's previous definition of fuel manufacturer to 

include importers. 59 FR 33042 (June 27, 1994). . - In today's 

notice, EPA is proposing to amend the definition of fuel 

manufacturer to exclude parties that add additives in amounts less 

than 1% by volume of the resulting fuel/additive mixture, and to 

exclude oxygenate blenders who meet the regulatory definition of 

a small business. In addition, EPA is proposing to amend the 

definition of "additive" to exclude substances composed solely of 

carbon and/or hydrogen. 

The term "manufacturer of a fuel or fuel additive" is used in 

§ 211(a), 211(b), and 211(e), but the Act is silent on the 

definition of "manufacturer" and "additive." Promulgating 

regulatory definitions of ''fuel manufacturer" and "additive" for 

purposes of implementing these subsections is within the Agency's 

discretion to interpret the statute it administers where that 

statute is silent with respect to a specific issue. See Chevron 

U.S.A.. Inc. v. NRDC. . 467 U.S. 837 (1984). A clear definition 

of "fuel manufacturer" is necessary for EPA to implement its 

authority effectively under § 211(a), (b), and (e), and to provide 

certainty as to which parties are subject to statutory requirements 

) * 

that apply to fuel manufacturers. In addition, it is necessary for 
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EPA to define "additive" to clarify which products are covered by 

EPA's regulations under S 211(e) covering registration and health 

effects testing requirements. 

EPA believes it is reasonable and appropriate to define "fuel 

manufacturer" to exclude parties that add additives in amounts less 

than 1% by volume of the resulting fuel/additive mixture. The 

health, effects information that such parties would be required to 

submit will also be obtained from the manufacturers of the 

additive, who would not be exempted under the proposed amendment. 

Therefore, excluding these parties from the definition of fuel 

manufacturer would reduce the generation and collection of 

duplicative information. For similar reasons, EPA also believes it 

is reasonable and appropriate to define "fuel manufacturer" to 

exclude oxygenate blenders who meet the regulatory definition of a 

small business. As discussed below, EPA believes that it is 

reasonable and appropriate to define "additive" to exclude 

substances composed solely of carbon and/or hydrogenAccording to § 79.1, the F/FA registration regulations apply 

to all manufacturers of designated fuels and fuel additives. 

Designated F/FAs, specified in §§ 79.30 - 79.33, are currently 

limited to motor vehicle gasoline and diesel fuels and to additives 

intended for use in these fuels. ..he applicable uefinitio, of a 

"fuel manufacturer" is provided in § 79.2(d): 

Fuel manufacturer means any person who, for sale or 

introduction into commerce, produces, manufactures, or 

imports a fuel or causes or directs the alteration of the 

chemical composition of, or the mixture of chemical 

compounds in, a bulk fuel by adding to it an additive. 

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The comprehensiveness of this definition has led to some 

redundancy in registration requirements. It has also led to 

problems and confusion arising from the fact that registration and 

testing responsibilities are sometimes transitive, i.e., they pass 

along from one manufacturer to another, generally from bulk 

additive manufacturers to their fuel manufacturer customers. A 

number of manufacturers have contacted EPA about these problems 

(e.g., see docket items VI-D-01, VI-D-05, VI-D-06, and VI-D-11). 

For example, terminal owners and others who buy and blend bulk 

additives into fuel are, according to the definition cited above, 

fuel manufacturersW These parties are therefore subject to the 

product registration and testing responsibilities applicable to 

fuel manufacturers. Under' the current regulations, they are 

required to register their fuel products, including the identity, 

purpose, and amount of bulk additive(s) which they blend (or intend 

to blend) into the fuel. Furthermore, they are responsible for any 

testing applicable to the resulting fuel/additive mixture, or for 

participating in one or more testing groups based on the 

composition of this mixture. In effect, their registration and 

testing responsibilities, and their grouping and cost-sharing 

opportunities, are defined by the composition of the bulk additives 

they mix '.ito f .••51 though in many "nstances they rn**-/ not <~*ven know 

the actual composition of the additive products they buy and use. 4-

Xi/ However, independent terminal operators which blend 

additives into their customers' fuels at the specific direction of 

such customers are not considered fuel manufacturers. Also, end 

users, such as fleet owners/operators who blend additives into bulk 

fuel for their own fleet use, are not considered fuel 

manufacturers. 
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The transitivity of registration and testing requirements from 

additive manufacturers to their fuel manufacturer customers has 

caused the number of parties subject to registration requirements 

to multiply and has led to confusion among the various parties 

along the F/FA production-blending-distribution chain. It may also 

have unintended affects on the F/FA commercial marketplace. In 

some cases, for example, blenders may stop using certain kinds of 

additives rather than incurring the responsibilities of a fuel 

manufacturer, or may switch from their traditional suppliers to new 

suppliers based on the grouping properties (set forth in § 79.56) 

of the competing additives. A particularly awkward result may 

occur when the direct manufacturer of an additive is exempt from 

testing requirements under the program's small business provisions 

(§ 79.58(d)), but the fuel manufacturers who buy and blend the 

additive into fuel do.not qualify for the exemption and must still 

test the additive/fuel mixture. To keep their customer base, some 

small manufacturers of "atypical" additives (defined in § 79.56(e)) 

state that they may find it necessary to waive their small business 

exemptions and shield their customers from additive testing 

requirements by fully funding the testing themselves (see, for 

example, docket item VI-D-06). Clearly, this Outcome would 

undermine the special allowances which EPA intended to grant to 

small businesses. A revised §79.58(d)(3) is proposed to remedy 

this situation, by exempting a fuel manufacturer from Tier 2 

requirements for the use of an additive which is exempt from Tier 

2. . 

Another problem associated with the definition of "fuel 

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manufacturer" has arisen as a result of a recent change in the 

definition of "fuel additive". The final rule which added health 

effects testing to the registration requirements for F/FAs (59 FR 

33042) also changed the definition of an additive, as specified in 

i 

§ 79.2(e). Previously, substances composed solely of carbon and/or 

hydrogen had been specifically excluded from the definition of an 

additive^; and thus did not have to be registered. Since these 

substances were not considered additives, parties which blended 

them into fuels were not considered fuel manufacturers and were not 

subject to the F/FA registration requirements on the basis of thait 

blending activity. 

Recognizing that all-hydrocarbon substances may have toxic 

properties, the new rule removed the exclusion of all-hydrocarbon 

substances from the definition of an additive. At the'time, EPA 

was particularly concerned about potential increased use of benzene 

and other aromatic hydrocarbon additives. However, the change in 

the definition of an additive has raised some unintended concerns. 

Under the new definition, hydrocarbon fuel blending stocks (e.g., 

kerosene, butane, propane), commonly used on a seasonal basis to 

change the evaporative or v"ow properties of conventional fuels, 

could now be considered as additives. Thus, parties which blend 

these fuel substances into gasoline or diesel fuel could be 

considered to fit the definition of "fuel manufacturt^." 

Potentially, hundreds of additional parties could be required to 

register as F/FA manufacturers, creating a substantial regulatory 

•02y*The presence of trace contamination with elements other 

than carbon and hydrogen did not factor into this exclusion. 

& 

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paperwork burden while providing little incremental information to 

EPA. This was not EPA's intent. Furthermore, the concern about 

benzene and other aromatics, which originally motivated EPA to 

delete the all-hydrocarbon exclusion from the additive definition, 

has now been largely addressed by the reformulated gasoline/antidumping rules and other regulatory mechanisms which limit the 

aromatic composition of gasoline and diesel fuels. In sum, 

therefore, the change in the additive definition has created a 

potentially large number of unintended new "fuel manufacturer" 

respondents among those who add commonplace blending stocks to 

gasoline and diesel fuels, while achieving little in regard to 

EPA's original intent. 

A substantial number of registrants is composed of persons who 

fit the definition of "fuel manufacturer" because they blend 

ethanol into gasoline. In the case of oxygenates other than 

ethanol, the oxygenate is generally added to gasoline at the fuel 

refinery, before the gasoline is distributed through the pipeline. 

These "upstream" oxygenate blenders tend to be relatively limited 

in number, and often are large fuel manufacturing businesses.. 

Ethanol, on the other hand, is generally prohibited from transport 

through the pipeline (pipeline policy, technical reasons), and must 

be added to the fuel downstream. Thus, rather than being blended 

by relatively few fuel refiners, ethanol is added to fuel by large 

numbers of terminal operators, fuel haulers, and some fuel 

retailers. Many such ethanol blenders qualify as small businesses 

under the definition in § 79.58(d)(2) and thus are excused from the 

Tier 1 and Tier 2 health effects testing provisions of the F/FA 

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registration regulations. Nevertheless, as fuel manufacturers, 

they must still comply with the basic reporting requirements of the 

F/FA registration program. This combination of circumstances 

maintains a significant paperwork burden for such respondents, 

while adding little information to EPA in regard to oxygenated 

fuels beyond that which is currently available through other 

program reporting mechanisms. 

B. Proposed Changes 

EPA proposes to address the problems summarized above by 

modifying the definitions of "additive" and "fuel manufacturer." 

First, EPA proposes to revise the current definition of an.additive 

(at § 79.2(e)) to exclude substances composed solely of carbon 

and/or hydrogen, thus reinstating the definition which was in 

effect prior to the final rule of May 27, 1994. As described 

previously, this action would provide regulatory relief to perhaps 

hundreds of companies which are now considered "fuel manufacturers" 

because they add common hydrocarbon stocks to finished fuels. It 

should be noted that persons who blend hydrocarbon stocks together 

to produce a usable motor vehicle fuel (rather than adding 

hydrocarbons to a finished fuel> would continue to be considered 

fuel manufacturers. 

Second, EPA proposes to add provisos to the definition of a 

fuel manufacturer (at § 79.2(d)) such that the addition of a small 

volume of any additive^/to fuel would not in itself cause any party 

x l ^ Of course, the additive itself must still be registered. 

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to be considered a fuel manufacturer, nor would the addition of an 

oxygenating additive by a party qualifying for the small business 

provisions of the registration program. The proposed new 

definition of a fuel manufacturer is as follows: 

Fuel manufacturer means any person who, for sale or 

introduction into commerce, produces, manufactures, or 

imports a fuel or causes or directs the alteration of the 

chemical composition of a bulk fuel, or the mixture of 

chemical compounds in a bulk fuel, by adding to it an 

additive, except that (1) a party who adds a quantity of 

additive(s) amounting to less than 1.0 percent by volume 

of the resultant additive(s)/fuel mixture is not thereby 

considered a fuel manufacturer, and (2) a party who 

qualifies as a small business under the criteria in § 

79.58(d)(2) of this subpart, and who adds an oxygenate 

compound(s) to fuel is not thereby considered a fuel 

manufacturer. 

This proposed definition would significantly reduce the number 

of F/FA registration respondents and would address the problems 

described above that result from the "transitivity" of registration 

and testing requirements under the current regulations. Under this 

definition, the addition of most "baseline" and "atypical" 

additives at ordinary treatment rates would not cause the blending 

party to be a fuel manufacturer because such additives are added in 

amounts less than 1% of the resultant mixture. In the general 

case, parties which add oxygenates to fuel, in art amount sufficient 

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to produce a fuel mixture categorized as non-baselina^k/. / would still 

be considered fuel manufacturers. EPA believes this to be 

appropriate because the relatively large added volumes can cause 

substantive changes in the basic . characteristics, emission 

properties, and toxic potential of the fuel. However, to reduce 

the number Of respondents required only to submit redundant 

registration paperwork, the proposed definition of a fuel 

manufacturer excludes oxygenate blenders who qualify for the small 

business provisions of the registration program (chiefly, small 

ethanol blenders). 

For convenience, it is proposed that the definition, of 

"oxygenate compound" at 40 CFR 79.50 also be incorporated at 40 CFR 

79.2(k). EPA requests comments on the proposed changes to the 

definitions of "additive" and "fuel manufacturer." 

C. Relationship to the Gasoline Detergent Additive Program 

An interface exists between the F/FA registration program and 

the detergent additive programs In order to avoid duplicate 

reporting requirements, the detergent additive program interim 

regulations in 40 CFR Part 80 make use of the existing F/FA 

\4/^-As specified in § 79.56(e) (3) (I) and (ii) , non-baseline 

F/FAs contain (among other criteria) no elements in addition to 

carbon, hydrogen, oxygen, nitrogen, and sulfur, and, in the case of 

gasoline F/FAs, contain 1.5 percent or more oxygen by weight, and, Q 

in the case of diesel F/FAs, contain 1.0 percent or more oxygen by N/v" 

weight. 

\5^Regulation of Fuels and Fuel Additives: Standards for 

Deposit Control Gasoline Additives. Proposed Rule: 59 FR 64213, 

Dec. 6, 1993. Interim Program Final Rule: 59 FR 54678, Nov. 1, 

1994. Certification Program Final Rule expected in 1996. These 

documents are available on EPA'.s TTNBBS bulletin board. See "For 

Further Informationi..," at the beginning of this notice. 

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registration system as the mechanism for collecting much of the 

information required of detergent additive blenders. However, if 

the definition of a fuel manufacturer is changed as proposed above, 

then detergent additive blenders would no longer be considered fuel 

manufacturers and would no longer be required to register under the 

F/FA registration program. Thus, the source of information on 

which EPA relies for the interim detergent additive program would 

no longer be available. However, as will be discussed in the 

upcoming final detergent rule, EPA has concluded that this 

information is no longer necessary. Therefore, there would be no 

adverse effect on the detergent additive program. 

IV. Small Business Definition 

In the F/FA registration program, qualification for special 

small business provisions is based in part on total annual sales 

revenue> specifically, a $50 million limit for manufacturers of 

baseline and non-baseline F/FAs, and a $10 million limit for 

manufacturers of atypical F/FAs (see §§ 79.58(d)(2) and (3), 

respectively). Communications from trade organizations which 

represent fuel retailers (docket item VI-D-05) suggest that these 

total sales criteria should be revised to take tax effects into 

account. These organizations point out that sales and excise taxes 

accumulate as the fuel passes alo.ig the ref inint,-distrij-.. * ionmarketing chain, but are generally not included in the price paid 

for the fuel (nor in the gross sales revenue of the seller) until 

the fuel is marketed at the retail level. In some instances, the 

accumulated sales and excise taxes on fuel, including applicable 

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taxes at the local, state, and federal levels,, may exceed 40 

percent of the price paid by consumers, and thus represents a 

comparable portion of the retailer's fuel-related sales revenues. 

The commenters argue that, since these tax effects are not 

reflected in the small business definition, small marketers are 

disadvantaged in comparison with small refiners and other upstream 

businesses. 

EPA agrees and proposes that the term "total annual sales" at 

§79.58(d) be modified by adding the following: "excluding any 

revenue which represents the collection of federal, state and/or 

local excise taxes and/or sales taxes". A revised §79.59(b)(5)(ii) 

is proposed to require the submittal, at EPA's request, of 

applicable bills of lading or other valid documentation to support 

the legitimacy of any fiiel sales amounts excluded as taxes. 

Comments are requested concerning these proposed revisions. 

V. Biodiesel Provisions 

Biodiesel fuels and most blends of bio- and conventional 

diesel fuel contain more than 1.0 weight percent oxygen and thus, 

according to § 79.56(e)(3)(ii)(B), fall into the non-baseline 

diesel category. Furthermore, under § 79.56(e)(4)(ii)(B)(2), 

biodiesel fuels derived from vegetable oil ("mixed ^lkyl esters of 

plant origin") a. » grouped separately from biodiesel fuels derived 

from animal fat ("mixed alkyl esters of animal, origin"). 

EPA established these two separate biodiesel groups because of 

concern that the composition of animal-derived and vegetable17 
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derived fuels might differ considerably, and thus might demonstrate 

different toxicologic properties. Both vegetable oil and animal 

fat are composed of triglycerides, and the esterification process 

used to convert the triglycerides to fuel (i.e., methyl esters) is 

the same for both. However, up to 3.0 percent of the resulting 

chemical mixture is composed of nonesterified reactants, other 

reaction products, and possible contaminants, and EPA has been 

concerned that these could vary significantly between the different 

feedstocks. 

In subsequent communications with EPA (docket item VI-E-01), 

representatives of the industry have asserted that the composition 

of biodiesel fuels of animal and plant origin have similar physical 

properties. As a result of their arguments, EPA is considering a 

change to the grouping rules which would permit animal- and 

vegetable-derived biodiesel fuels to be grouped together 

revised §79.56(e)(4)(ii)(B)(2) is proposed. EPA requests comments 

on this potential action. Data demonstrating the qualitative and 

quantitative differences between biodiesel fuels from different 

feedstocks, including the identity and amount of contaminants, 

would be particularly helpful to EPA's determination of the most 

appropriate grouping rules for these fuels. Available data 

comparing the speciated emissions of these fuels would also be of 

W

 0 \|t 

\§YIt is important to note that, notwithstanding any grouping 

arrangements permitted under the program's grouping rules, EPA 

retains the authority in § 79.54(a) to require Tier 3 testing 

either on an individual or group basis, and to require different 

representative(s) of a group to be tested than may have been tested 

at the Tier 1 and/or Tier 2 level. Thus, even if the regulations 

were to be changed to allow biodiesel fuels to group together, EPA 

would not be precluded from requiring vegetable-derived and animalderived biodiesel fuels to undergo separate Tier 3 testing. 

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interest. 

Section 79.56(e) (4) (ii). (B) (2) .ii. of the current regulations 

contains generic requirements for choosing the representative to be 

used in testing for the health effects of biodiesel and other 

defined groups of oxygenating compounds. EPA is considering a 

requirement specific to biodiesel which would require that 100 

percent biodiesel fuel be used as the biodiesel group's test 

representative. This would maximize the likelihood of detecting 

any differences in the emissions and/or toxicologic properties 

between conventional diesel and biodiesel fuels. Under the 

existing regulations, it is likely that a 20 percent biodiesel 

formulation will be selected as the test representative; thus, 

lower exposures to biodiesel emissions would occur during the 

testing. On the other hand, a 20 percent formulation does 

currently appear to be the more likely formulation to be introduced 

into commerce, at least in the near future. Thus, EPA requests 

comment on which biodiesel fuel specification (20 percent, 100 

percent, or some other percentage) would be most appropriate in the 

context of the testing program. Comments are also requested on the 

practicality of each optir with respect to test vehicle/engine 

compatibility. 

VI. Synthetic Fuel Provisions 

A. Background 

According to §§ 79.56(e)(3)(I)(B) and (3)(ii)(B), a fuel 

derived from any synthetic crude source, such as shale, coal, or 

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tar sands, is assigned to a non-baseline category. The regulation 

does not specify a minimum amount of synthetic component which 

would cause a fuel to fall into the non-baseline category. 

Sections 79.56(e)(4.(ii)(A)(3) and (ii)(B)(3). for gasoline and 

diesei F/FAs respectively, define separate non-baseline groups for 

"formulations derived from each particular non-conventional 

petroleum source, or process" (italics added for emphasis), and 

lists the following types of fuel formulations as examples of such 

groups: "coal-derived formulations; chemically-synthesized 

formulations (including those using recycled chemical of 

petrochemical products); tar sand-derived formulations; shalederived formulations; and other types of soil-recovered products 

used in formulating (fuel)". 

Since publication of these regulations, EPA has received 

communications and information from the affected industry (see. 

docket items VI-D-02 and VI-D-03) claiming that synthetic fuels 

should be categorized as baseline rather than non-baseline 

products. They point out that the current regulations do not 

reflect the fact that finished motor vehicle fuels are rarely, if 

ever, refined solely from synthetic crude. Rather, when synthetic 

crude is used, it generally comprises a relatively small fraction 

(e.g., iO-15 percent) of the total crude which is refined into 

motor vehicle fuel, _•_-; -eover, the industry claims that such fuels, 

once refined, are not significantly different from conventional 

fuels. They are not labeled differently or stored separately from 

fuels derived wholly from conventional crude sources. In fact, 

they are commonly distributed by way of the conventional fuel 

20 
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pipeline system. Downstream parties may therefore buy and sell, 

additize, and otherwise handle fuels with some synthetic 

derivation, without even knowing when or if this is the case. 

The F/FA registration program covers only designated motor 

vehicle fuels and their associated additives. It does not require 

the registration of crude feedstocks from which these F/FAs are 

made. Thus, in the case of conventional fuels, it is not the 

entity which takes crude oil from the ground who is responsible for 

fuel registration; rather, it is the entity which refines finished 

fuel from crude oil who is required to have that fuel registered 

prior to placing it in commerce^ Similarly, synfuel registration 

is not the responsibility of parties who mine (or otherwise obtain) 

a synthetic crude source and subject it to upgrading and 

purification processes prior to actual fuel refining. Only after 

the synthetic crude is refined (alone or as part of a 

synthetic/conventional crude mixture) is the product subject to 

registration. 

Clearly, the responsibility for registering synfuel falls to 

those business entities (usually fuel refiners) which are the first .fi, 

parties along their respective production chains to introduce..into 

commerce a designated motor vehicle fuel derived in whole or in 

part from a nonconventibnal source, and conforming to standard 

specifications for the designated fuel. These manufacturers are 

responsible for testing the synfuel products they have had 

\hyOf. course, this distinction is moot if the two activities 

are accomplished by the same business entity. 

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.registered. Thus it is incumbent on these manufacturers to take 

steps to determine if any of the materials from which they produce 

designated fuels are of synthetic origin. Under the current 

grouping provisions, those who manufacture synfuel derived from the 

same non-conventional source are able to form testing groups within 

the applicable (gasoline or diesel) non-baseline categories. 

B. Proposed Changes 

In the event that such synfuel groups are formed, the current 

regulations do not contain adequate guidelines for choosing synfuel 

group representatives. To facilitate detection of differences 

between a synthetic fuel and the respective conventional fuel, EPA 

proposes that, for any synfuel group, the representative should be 

a fuel derived totally from the relevant synthetic source. If 

production of a useable 100 percent synfuel is impractical, then 

the group representative could be a fuel reflecting the highest 

percentage of syncrude feedstock that is practical and suitable for 

operating the relevant engine type. Revised §§ 

79.56(e)(4)(ii)(A)(3)(ii) and (B)(3)(ii) are proposed. 

Alternatively, the synfuel group representative could be specified 

as a fuel ref lectin., the highest percentage o.f synthetic crude 

which is actually input to any member refinery's crude distillation 

unit(s). The test fuel would otherwise be required to conform to 

the additization requirements and any other relevant base fuel 

specifications in § 79.55. Comments on these proposals for 

selecting synfuel group representatives are requested. 

EPA also requests comments on some potential changes to the 

22 
P.24 

synfuel grouping rules themselves. First> EPA proposes to delete 

the phrase "..or process" from §§ 79.56(e)(4)(ii)(A)(3) and 

(ii)(B)(3) of the registration regulations. The inclusion in these 

sections of non-conventional processes in addition to nonconventional sources as delineatefs of non-conventional fuels is 

potentially misleading. For example, the current language can be 

interpreted as meaning that heavy, but otherwise conventional crude 

feedstocks should be considered non-conventional (and therefore 

non-baseline) because they need slight modification prior to sale 

and transport. The proposed changes at §§ 79.56(e)(3)(I)(B) and 

(3)(ii)(B) to delete the phases "heavy oil deposits" would narrow 

these provisions so that they focus on fuels of greater concern to 

EPA, i.e., fuels derived from non-conventional sources, not from 

mechanical or chemical production processes on otherwise 

conventional feedstocks. Comments are requested on this proposed 

revision. 

In developing the current regulations, EPA sought to segregate 

non-conventional fuels into separate non-baseline groups because of 

concerns that they were likely to contain unknown contaminants and 

relatively high levels of trace or background elements. However, 

limited published information and other data received from the 

industry suggest that, after processing, some mined syncrude 

feedstocks may not be significantly different from more 

conventional crudes. 

Because they must be compatible with conventional refinery 

processes and must be fungible with conventional fuels, synthetic 

23 
P.25 

'crudes are reportedly subjected to extensive upgrading to remove 

heavy residual oils ("tank bottoms"), sulfur, inorganic elements, 

organo-metallic compounds, and clays prior to shipping to 

refineries. In preparing its product for sale, the syncrude 

manufacturer typically subjects the mined material to de-salting 

and coking processes (to remove metal contaminants) and atmospheric 

and vacuum distillations (to remove tank bottoms and asphaltic 

residues). Limited product assay results provided to EPA (docket 

item VI-D-02) indicate that syncrude feedstocks may be lower than 

typical petroleum crudes in vanadium, nickel, and iron. The 

industry monitors these characteristics because several catalytic 

refinery processes are intolerant of metallic contaminants. 

For these reasons, EPA is considering options that would 

further ease or, possibly, remove some of the current provisions 

which distinguish some fuels derived from synthetic sources from 

conventional petroleum fuels. Substantive comments and additional 

data are needed to help EPA decide whether any of these additional 

options should be adopted and, if so, to which crude sources they 

should apply (i.e., some or all mined crude sources, other 

petrochemical crude sources, or all types of crude feedstocks). 

One alternative provision und^r consideration wo'" Id permit a 

synfuel manufacturer (or group) to submit the results of a the Dugh 

chemical analysis of the raw synfuel in conjunction with the Tier 

1 emission characterization data. This special analysis would 

emphasize the identification of elevated levels of trace elements 

or compounds as compared with the base fuel for the respective fuel 

24 
P.26 

.family. The data would need to include sufficient numbers of fuel 

samples to be viewed as a valid sampling of the range of the 

particular crude feedstock and, likewise, would need to cover a 

broad range of measurable feedstock characteristics. Based on the 

special Tier 1 analysis, EPA would determine, on a case-by-case 

basis, whether the synfuel in question should be permitted to join 

the baseline group for purposes of Tier 2, or whether the synfuel 

would continue to be categorized as non-baseline. 

Another possibility under, consideration would simply delete 

some or all synthetic crude sources from the list of nonconventional sources. This would mean that fuels from these 

feedstocks would be classified as baseline products. This choice 

would recognize that it is in the vital interest of the fuels 

industry to continue to monitor the quality of the synfuels that 

are transported ih the existing pipeline systems. The demands of 

fungibility would thus be assumed to maintain the quality and 

similarity of syncrude products on a par with that of more 

conventional F/FAs. 

Comments are requested on these possible provisions. To the 

degree that such comments are substantive and provide objective 

data supporting these alternative provisions, EPA may be more 

persuaded that i.r original concerns about synfue_ competition may 

have been exaggerated. Comments are also requested on whether 

shale-derived synfuels should continue to be categorized as nonbaseline, even if fuels from other mined sources (coal, tar sands) 

are re-categorized as baseline. 

25 
P.27 

C other Alternatives 

Under a different approach, the grouping system's current 

definition of synthetic fuels would be retained, but a particular 

manufacturer's synfuel product would be categorized as baseline or 

non-baseline depending on the proportion of synthetic crude 

represented in the finished product. As mentioned earlier, the 

current F/FA regulations do not establish a minimum amount of 

synthetic crude feedstock which causes a fuel to be categorized as 

non-baseline. Given the variability in syncrude proportion and the 

apparent fungibility of many synfuel products with conventional 

fuels, such a minimum would appear to be appropriate. Under this 

approach, for example, EPA could specify that a synfuel product 

will be considered non-baseline only if more than 15 percent by 

volume of the crude unit charge (i.e., the input to a refinery's 

crude distillation unit(s)) is composed of synthetic crude or mixed 

synthetic-conventional crude feedstock/ The choice of 15 percent 

as the cutoff volume would mean that most of the synfuels produced 

today would be classified as baseline. Since their manufacturers 

could thus join the respective baseline group(s), it is likely that 

some types of synfuel would not routinely undergo testingAy In 

practice, any cutoff point adopted in the regulations would 

probably function as a cap on the syncrude proportion used by 

vU 

\£<Y This statement assumes there are no other conditions (e.g., 

high oxygen content) that would cause the fuel to be non-baseline. 

s^fs However, under the Tier 3 provisions of the F/FA 

registration regulations, EPA could still require any emission 

speciation and/or health effects testing it deems necessary if, at 

some future time, EPA finds that a synfuel or other F/FA is not 

well represented by the test fuel designated to represent its F/FA 

group. r 

26 
synfuel manufacturers. 

As a variation on this approach, different baseline/nonbaseline cutoff points could be established for different kinds of 

synfuels. Under this variation, fuels containing more than 15 

percent content derived from mined sources (e.g., coal, shale, and 

tar sands) would be considered non-baseline, while fuels containing 

more than 2 percent content derived from other petrochemical 

sources (e.g., used motor oils, recovered chemical spills, recycled 

plastics, and industrial waste streams) would be considered nonbaseline. Other cutoff points might also be appropriate. 

EPA requests comment as to the appropriateness of using 15 

percent of crude unit charge as the cutoff point for all syncrude 

feedstocks in determining whether a fuel belongs in a non-baseline 

group. Comments are also requested on the alternative approach of 

setting different cutoff points for different types of synfuel. 

Suggestions for other cutoff points than the ones discussed above, 

with support and justification for such suggestions, are welcome. 

In addition, EPA requests information on the amount of syncrude 

typically represented in sy-fuels as they leave the refinery, as 

well as the usual maximum amount of syncrude used in such fuels 

today. information is also sought on any differences in these 

formulation practices which may occur as a function of the typ^ of 

syncrude in question. 

VII. De Minimis Provisions 

A. Background 

27 
In the NPRM published April 15, 1992, EPA raised the 

possibility of setting de minimis levels for some atypical F/FAs\% 

i.e., maximum concentrations or emission rates for atypical 

elements below which the manufacturers of F/FAs containing such 

elements would be excused from some or all of the testing 

requirements for the product. EPA recognized that the extra 

emission testing requirements proposed for atypical F/FAs and the 

relatively scarce grouping opportunities among such products could 

subject manufacturers of atypical F/FAs to considerably higher 

registration costs than other manufacturers. De minimis provisions 

were discussed as a possible way to reduce these burdens when 

atypical F/FAs could reasonably be anticipated to have no adverse 

effects on the public health or the environment (i.e., having no 

incremental effects relative to the effects of the associated base 

fuel). , The proposed de minimis provision would be limited to 

specific atypical elements which were generally regarded as not 

producing overt toxicological effects when inhaled and were present 

in the product and its emissions in very low quantities. 

When the F/FA test rule was promulgated in May 1994, however, 

these special de minimis provisions were not finalized. EPA noted 

that very little speciated chemical compound information was 

available on .atypical F/FAs or their emission products, from which 

possible atypical F/J_. candidates and de minimis levels could be 

identified. Likewise, little data existed regarding the potential 

toxicities, exposures, or health risks associated with atypical 

violin the gasoline and diesel fuel families, an atypical F/FA 

is one which contains one or more elements other than carbon, 

hydrogen, oxygen, nitrogen, and/or sulfur. 

28 

\JL 
P.30 

F/FAs or their emissions. Finally, there was a concern that, in 

promulgating, de-minimis levels.for atypical elements, EPA's actions 

would be misinterpreted as setting "safe" levels for exposure to 

various atypical compounds when, in fact, very few applicable, 

reliable health and safety exposure standards exist for any of the 

substances of concern. 

However, the practical effect of not promulgating de minimis 

levels for some atypical F/FAs has been to subject all atypical 

F/FAs to the same level of scrutiny, even though the overall level 

of concern about their potential health effects may be markedly 

different. Thus, under the existing regulations, manufacturers of 

F/FAs containing such unlike elements as, say, mercury and sodium 

each have to comply with the same detailed emissions 

characterization and health effects testing requirements under the 

same set of conservative assumptions. 

In an attempt to improve this outcome, EPA is thus again 

proposing a de minimis provision. This proposed provision, 

described in the next section, differs somewhat from the previous 

de minimis proposal; however, it does not solve all of the original 

objections. Reliable quantitative data on the toxicity of most 

atypical F/FAs and their emission products is still lacking. 

Nevertheless, the proposal described below is conservative in 

approach and applicability, and EPA believes it to be a reasonable 

and prudent alternative to the current program, which allows for no 

distinctions to be made based on the anticipated health effects and 

exposures associated with substances which, in fact, vary greatly 

29 
P.31 

in chemical composition and rate of usage. 

EPA wishes to emphasize once again that, in proposing de 

minimis proyisions for certain atypical F/FAs, the Agency is not 

setting a safety level for these F/FAs or their emissions that is 

meaningful or valid outside a very limited context. The proposal 

recognizes that a relatively lower level of overall health-related 

concern exists for some of the atypical elements used in F/FAs, 

especially under limited exposure conditions at very low 

concentrations .\/ The relatively low production volumes of most 

atypical F/FAs means that the population at large would potentially 

be exposed to exceedingly small amounts of the elements for which 

EPA is proposing to set de minimis levels, particularly after they 

undergo combustion in motor vehicle engines and the emissions are 

diluted in air. In combination, these factors make it extremely 

unlikely that the proposed de minimis provisions could result in 

adverse public health or welfare outcomes. Nevertheless, should 

such concerns arise in the future, the proposed de minimis 

provisions would in no way limit EPA's flexibility under its Tier 

3 testing authority to require additional emission characterization 

and/or toxicologic testing of anv affected F/FA, and to take any 

\^/4Mtowever, recent studies suggest that pulmonary injury may 

be caused by inhalation exposu e _o substances generally regarded 

as biologically inactive, if th exposure to such substances is in 

the form of "ultrafine" particles (less than 20nm). See, for 

example, OberdSrster, G., etal., "Role of the Alveolar Macrophage 

in Lung Injury: Studies with Ultrafine Particles," Environmental 

Health Perspectives. 97: 193-199, 1992. While testing to detect 

the potential occurrence of ultrafine particles of atypical 

elements in F/FA combustion emissions is outside the scope of Tiers 

1 and 2, such testing could be required under Tier 3 if deemed 

necessary by EPA. EPA's authority to require such testing would 

not be affected by any de minimis provision for which a fuel or 

additive might otherwise qualify. 

30 

I 
P.32 

•follow-up regulatory action warranted by the results. 

B. Proposed Provisions 

1. Selection of Elements 

A number of atypical elements are reported by their 

manufacturers to be components of one or more F/FAs occurring on 

EPA's F/FA registration databaseV. EPA is today proposing de 

minimis provisions applicable tb the following nine atypical 

elements: 

s * 

Aluminum (Al) Magnesium (Mg) 

Boron (B) Phosphorus (P) 

Calcium (Ca) Potassium (K) 

Sodium (Na) Iron (Fe) 

Zinc (Zn) 

These nine elements were selected by evaluating a number of 

factors. First, any element (alone or in compound form) known or 

believed to have significant inhalation-related health effects or 

to be a precursor to emission species of particular concern was 

eliminated as a candidate for the de minimis provision. For 

example, elements in the halogen family were eliminated because of 

their occurrence in toxic chemical species (e.g., halogenated 

methane compounds) and/or their potential role in forming dioxin 

and dioxin-like compounds. Other examples include manganese, 

mercury, tin, and lead, which were eliminated from consideration 

\^<^These elements occur on EPA's F/FA registration database 

as constituents of some diesel F/FAs, or in aftermarket gasoline 

additives which were "grandfathered" when restrictions on such 

atypical elements were implemented. These "grandfathering" 

provisions were previously reviewed in the NPRM and Reopening 

Notices for the F/FA Registration rulemaking (see 57 FR 13168 and 

59 FR 8886). 

31 

vV 
P.33 

because of their neurologic effects, and cobalt, platinum, silicon, 

and antimony,,, which were eliminated because of concerns about their 

potential respiratory effects in some chemical forms. 

EPA also examined any existing exposure assessment values 

which may exist for the atypical elements (or compounds containing 

them), including industrial exposure guidelines such as Threshold 

Limit Value (TLV), Permissible Exposure Limit (PEL), Recommended 

Exposure Limit (REL), and Health Effects Assessment Summary Table 

(HEAST) values. Recognizing that none of these values is 

specifically intended for use in estimating the toxic potential of 

long-term continuous exposure's to the general population, EPA 

looked at them only as general, relative indicators of potential 

toxicity, to be viewed in conjunction with each other and subject 

to conservatively-applied scientific judgment. In this way, EPA 

divided the atypical elements into two groups. FOr one group, 

containing the nine elements listed above, it appeared that limited 

exposures to ambient concentrations of at least 0.1 milligrams of 

the elements per cubic meter of air (mg/m3) could occur without 

raising appreciable concerns. For all the remaining atypical 

elements, specific public health and/or welfare effects issues were 

identified and/or the exposure assessment values generally 

indicated that health-related concerns may arise at exposure levels 

considerably lower than 0.1 mg/m3.. EPA decided tl __t de j... t mis 

provisions would therefore not be proposed to apply to any of the 

elements in the latter group. 

EPA requests comments on the appropriateness of establishing 

32 
P.34 

a de minimis provision for atypical F/FAs, given the acknowledged 

lack of reliable quantitative toxicity data for most of the 

substances concerned. Specific comments are also requested on the 

approach described above for differentiating between high- and lowconcern atypical elements, and on the nine elements proposed as 

candidates for the potential de minimis provision. Should some of 

these nine elements be deleted from the list? 

2. De Minimis Level 

The de minimis provision could theoretically be structured to 

apply either to 1) the amount of an atypical element in the "raw" 

state (i.e., in the uncombuste'd fuel/additive mixture) , or 2) the 

amount occurring in the combustion emissions. While the emissions 

approach might appear to provide a more direct measurement of the 

substances of concern, EPA believes that, in this instance, the raw 

mixture approach provides a simpler and ultimately more effective 

mechanism for manufacturers to apply and for EPA to evaluate and 

enforce. Basing the de minimis provision on the concentration of 

atypical elements in the raw state avoids a number of complicated 

issues that would arise if the provision were based on measurement 

of atypical elements in the emissions, e.g.: 1) how much 

accumulated mileage would be required before generating, sampling, 

and analyzing the emissions for possible de minimis qualification; 

2) how _tny sam, V:s would be neec a; 3) once samp -id, wh c kinds of 

emissions analyses Would be required; 4) how accurate and sensitive 

would the detection equipment have to be; and 5) how EPA could 

efficiently confirm the results? 

33 
P.35 

As discussed above, for the group of nine candidate elements, 

it appears that-ambient air concentrations of at least 0.1 mg/m3 

(100 /xg/m3) could occur for limited exposures without raising 

significant concerns. The concentration of a particular elemental 

constituent of a fuel/additive mixture which, after combustion in 

an engine, would yield a given concentration of the element in air 

depends on a number of factors and relationships, e.g., the 

chemical characteristics of the element and its host compound (s.) , 

the nature of the base fuel, engine type, and driving cycle 

involved, the scale and complexity of the ambient environment, etc. 

Thus, corresponding fuel and air concentrations cannot be 

calculated with precision. ' However, based on a series of 

approximations and conservative assumptions, EPA estimates that a 

concentration of 25 parts per million (ppm) of atypical element(s) 

in a base fuel (i.e., 0.0025 percent by weight}^3/should generally 

yield a concentration in air of less than 0.1. mg/m3, even under the 

theoretical assumption that the characteristics of the ambient air 

are a direct function of the combustion emissions of a single 

vehicle operating on the atypical F/FA mixtureVV 

Thus, EPA is today proposing a de minimis provision based on 

a qualifying level of 25 ppm in base fuel, disregarding trace 

amounts of these elements which may exist in the unadditized base 

fuel. Specifically, if an atypical additive contains ho atypical 

\1^ - These measurements refer to the specified elements 

themselves, not to the weights of the compounds in which these 

elements may be bound. 

\14/*t£- Specif ical ly, the very conservative assumption is made 

that the ambient air consists of fully-passed-through emissions of 

the atypical element(s) diluted by a factor of 1 to 2,000. 

34 

i 
P.36 

elements other than Al, B, Ca, Fe, Mg, P, K, Na, and/or Zn, and if 

the total of these elements added to base fuel does not exceed 25 

ppm by weight when the additive is mixed into the applicable base 

fuel at the highest treatment rate recommended by the • additive 

manufacturer, then the additive (and F/FA mixture) would qualify 

for the de minimis provision. Comments on this general approach 

and on the proposed de minimis level are requested. The special 

allowances for which such F/FAs would qualify are described in the 

next section. 

3. Allowances for Qualifying F/FAs 

EPA proposes that manufacturers of atypical F/FAs which 

qualify for the de minimis provision, under the criteria specified 

above, would be excused from the testing requirements included in 

Tier 2 (§ 79.53). This is the same allowance provided by the 

existing regulation (§ 79.58(d)(3)) for atypical F/FAs produced by 

small manufacturers (i.e., those with less than $10 million in 

annual revenue). The de minimis provision would not excuse 

manufacturers from the Tier 1 emission characterization 

requirements that pertain specifically to atypical F/FAs, i.e., the 

identification and measui .invent of individual emission products 

containing the atypical elements (§ 79.52(b)(2)(iv) and, if 

applicable, § 79.52(b)(3)(iv)). Notwithstanding the de minimis 

provision nor any other special provisions for whicli a F/FA ray 

qualify, the provisions of Tier 3 permit EPA to require any 

additional testing at its discretion, including testing which might 

have been required in the absence of the special provision. 

35 
P.37 

Comments on this proposal to excuse qualifying F/FAs from Tier 

2 requirements are requested. See the proposed regulatory language 

at § 79.58(f). Comments are also requested on the scope and 

specific details of the proposed de minimis provision in general. 

Any suggestions for easing the provision (i.e., adding elements or 

increasing the de minimis level) should be accompanied by data to 

justify such a change. This proposal is deliberately based on 

conservative assumptions and, EPA requests that commenters provide 

solid supporting data to justify any suggested changes which would 

widen the applicability of the proposed provision. EPA is unlikely 

to adopt any such suggestions from commenters without such data. 

VIII. Minor Changes to the Testing Requirement for Registration 

Minor changes to the testing requirements are proposed. In 

the final rules section of this Federal Register, these changes are 

being promulgated as a direct final rule without prior proposal, 

because they are viewed as noncontroversial and no adverse comments 

are anticipated. A detailed rationale for these proposed changes 

is set forth in the direct final rule. If an adverse comment on 

request for hearing is not received in response to the direct final 

rule, no further activity is contemplated in relation to this 

proposed rule. If an adverse comment or hearing request is 

received, the portio of the direct final rule at is~ue will be 

withdrawn and all public comments received will be addressed in a 

subseiquent final rule based on this proposed rule. EPA will not 

institute a second comment period on these minor changes. Any 

parties interested in commenting should do so at this time. 

36 
P.38 

'IX. Tier 1 Exposure Analysis 

Section 79.52(c) requires a manufacturer, using annual and 

projected production volume, marketing, and distribution data 

(already required to submitted as a condition for registration), to 

provide a qualitative discussion of the potential public health 

exposures to the emission products of its fuels and/or additives. 

Upon review, EPA has concluded that this qualitative discussion 

will add little relevant information beyond the registration data. 

Therefore, it is proposed to delete §79.52(c) and modify 

introductory paragraph 79.52(a) accordingly. 

37 
P.39 

X. Environmental and Economic Impacts 

The environmental impacts of today's action are minimal, as 

discussed above. Additionally, economic impacts are beneficial to 

affected manufacturers due to the additional flexibility afforded 

in today's notice. Minimal anti-competitive effects are expected. 

A regulatory support document which presents EPA's analysis of the 

cost impacts of the May 1994 rule is available in Public Docket A90-07 located at Room M-1500, Waterside Mall (ground floor), U.S. 

Environmental Protection Agency, 401 M St. S.W., Washington, D.C. 

20460. ' 

38 
•XI. Regulatory Flexibility Analysis 

EPA has determined that it is not necessary to prepare a 

regulatory/Flexibility analysis in connection with this rule. This 

rule will reduce regulatory burdens on small businesses by reducing 

or eliminating the reporting and testing requirements for many 

small businesses. EPA has determined that this rule will not.have 

a significant adverse economic impact on a substantial number pf 

small businesses. .. • . •• 

XII. Administrative Designation 

Pursuant to Executive Order 12866(58 FR 51735' [October 4, 

*V 

39 
P.41 

*1993]), the Agency must determine whether a regulatory action is 

"significant".., .and therefore, subject to OMB review and the 

requirements of the executive order. The order defines 

"significant regulatory actions as one that is likely to result in 

a. rule that may: 

(1) Have an annual effect on the economy of $100 million 

or more or adversely affect in a material way the 

economy, a sector of the economy, productivity, 

competition, jobs, the environment, public health or 

safety, or State, local or tribal governments or 

communities; 

(2) Create a serious inconsistency or otherwise interfere 

with an action taken or planned by another agency; 

(3) Materially alter the budgetary impact of entitlement, 

grants, user fees, or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues arising out of 

legal mandates, the President's priorities, or the 

principles set forth in the Executive Order. 

Pursuant to the terms of Executive Order 12866, it has been 

determined that this notice is proposal rulemaking is not a 

"significant regulatory action", The proposals in this notice will 

decrease the number of parties to which these regulations apply and 

39 cv 
P.42 

* will reduce the requirements and costs of other parties subject to 

the regulationsXVI. Paperwork Reduction Act 

The paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq., 

and implementing regulations, 5 CFR Part 1320, do not apply to this 

action as it does not involve the collection of information as 

defined therein. 

XVII. Unfunded Mandates Act 

# 

Under section 202 of the Unfunded Mandates Reform Act of 1995 

("Unfunded Mandates Act"), signed into law on March 22, 1995, EPA 

must prepare a budgetary impact statement to accompany any proposed 

or final rule that includes a Federal mandate that may result in 

expenditure by State, local, and tribal governments, in the 

aggregate; or by the private sector, of $100 million or more. 

Under Section 205, EPA must select the most cost-effective and 

least burdensome alternative that achieves the objectives of the 

rule and is consistent with statutory requirements. Section 203 

requires EPA to establish a plan for informing and .advising any 

small governments that may be significantly or uniquely impacted by 

the rul~. 

EPA has determined that the action promulgated today does not 

include a federal mandate that may result in estimated costs of 

$100 million or more to either State, local, or tribal governments 

40 
P.43 

••* in the aggregate, or to the private sector. This proposed action 

does not establish regulatory requirements that may significantly 

or uniquely affect small governments. In fact, this proposed 

action has the net effect of reducing the burden of the fuel and 

fuel additive registration program on regulated entities. 

Therefore, the requirements of the Unfunded Mandates Act do not 

apply to this action. 

Proposed of Fuel i o n — • 

Page 

uel Additives RegisJ 

[41]. 

XVIII. Statutory Authority 

The statutory authority for this proposed rule is provided by 

sections 205(b) and (c), 211, and 301(a) of the Clean Air Act as 

amended (42 U.S.C. 7524(b) and (c), 7545, and 7601(a), Public Law 

95-95). 

v« 

List of Subjects in 40 CFR part 79 

Fuel, Fuel additive, Gasoline, Motor vehicle pollution, 

Penalties/^ IriujipoidLlO.. py kei'erenc 

Dated: 

M Zl 1996 

Administrator 

<-* ° at <*' 

>£• 

41