[Federal Register Volume 61, Number 134 (Thursday, July 11, 1996)]
[Proposed Rules]
[Pages 36535-36543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17550]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 79

[FRL-5532-5]


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.

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SUMMARY: This document 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 gasoline.

DATES: Written comments on the issues presented in this document will 
be accepted until August 12, 1996.

ADDRESSES: Comments should be sent in duplicate to EPA Air Docket 
Section (LE-131); Attention: Public Docket No. A-90-07; 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 charged by EPA for photocopying services.

FOR 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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              Category                  Examples of regulated entities  
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Industry............................  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 manufacturers to submit information 
on their F/FA products, such as 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

[[Page 36536]]

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 rule also includes 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 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 to 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 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 CFR 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 and additives from introducing them into commerce 
without having them registered. Section 211(b) describes the 
registration requirement for designated fuels and fuel additives. 
Pursuant to Sec. 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 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 
Sec. 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 
Sec. 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 
Sec. 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 EPA to define ``additive'' to clarify 
which products are covered by EPA's regulations under Sec. 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 hydrogen.
    According to Sec. 79.1, the F/FA registration regulations apply to 
all manufacturers of designated fuels and fuel additives. Designated F/
FAs, specified in Secs. 79.30-79.33, are currently limited to motor 
vehicle gasoline and diesel fuels and to additives intended for use in 
these fuels. The applicable definition of a ``fuel manufacturer'' is 
provided in Sec. 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.

    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

[[Page 36537]]

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 
manufacturers.1 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 into fuel, though in many instances they 
may not even know the actual composition of the additive products they 
buy and use.
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    \1\ 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 Sec. 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 (Sec. 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 Sec. 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 Sec. 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 
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 
Sec. 79.2(e). Previously, substances composed solely of carbon and/or 
hydrogen had been specifically excluded from the definition of an 
additive,2 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 that blending 
activity.
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    \2\ The presence of trace contamination with elements other than 
carbon and hydrogen did not factor into this exclusion.
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    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 flow 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 manufacturer.'' Potentially, hundreds of 
additional parties could be required to register as F/FA manufacturers, 
creating a substantial regulatory 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/anti-dumping 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 Sec. 79.58(d)(2) and thus are 
excused from the Tier 1 and Tier 2 health effects testing provisions of 
the F/FA 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 
Sec. 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

[[Page 36538]]

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 Sec. 79.2(d)) such that the addition of a small volume 
of any additive 3 to fuel would not in itself cause any party 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:

    \3\ Of course, the additive itself must still be registered.

    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 Sec. 79.58(d)(2) of this subpart, and who adds 
an oxygenate compound(s) to fuel is not thereby considered a fuel 
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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 an amount sufficient to produce a fuel mixture 
categorized as non-baseline,4 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).
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    \4\ As specified in Sec. 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, 
in the case of diesel F/FAs, contain 1.0 percent or more oxygen by 
weight.
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    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 program.5 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 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.
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    \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 
Information. . .,'' at the beginning of this notice.
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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 Secs. 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 along the 
refining-distribution-marketing 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 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 
Sec. 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 Sec. 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 fuel 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 
Sec. 79.56(e)(3)(ii)(B), fall into the non-baseline diesel category. 
Furthermore, under Sec. 79.56(e)(4)(ii)(B)(2), biodiesel fuels derived 
from vegetable oil (``mixed alkyl esters of plant origin'') are 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 vegetable 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

[[Page 36539]]

considering a change to the grouping rules which would permit animal- 
and vegetable-derived biodiesel fuels to be grouped together.6 A 
revised Sec. 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 interest.
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    \6\ It is important to note that, notwithstanding any grouping 
arrangements permitted under the program's grouping rules, EPA 
retains the authority in Sec. 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 animal-
derived biodiesel fuels to undergo separate Tier 3 testing.
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    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 option with respect to test vehicle/engine compatibility.

VI. Synthetic Fuel Provisions

A. Background

    According to Secs. 79.56(e)(3)(I)(B) and (3)(ii)(B), a fuel derived 
from any synthetic crude source, such as shale, coal, or 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 diesel 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 or 
petrochemical products); tar sand-derived formulations; shale-derived 
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., 10-15 percent) of the total crude 
which is refined into motor vehicle fuel. Moreover, 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 
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.7 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.
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    \7\ Of course, this distinction is moot if the two activities 
are accomplished by the same business entity.
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    Clearly, the responsibility for registering synfuel falls to those 
business entities (usually fuel refiners) which are the first parties 
along their respective production chains to introduce into commerce a 
designated motor vehicle fuel derived in whole or in part from a 
nonconventional source, and conforming to standard specifications for 
the designated fuel. These manufacturers are responsible for testing 
the synfuel products they have had 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 Secs. 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 reflecting the highest percentage of 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 
Sec. 79.55. Comments on these proposals for selecting synfuel group 
representatives are requested.
    EPA also requests comments on some potential changes to the synfuel 
grouping rules themselves. First, EPA proposes to delete the phrase 
``..or process'' from Secs. 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 non-conventional sources

[[Page 36540]]

as delineaters 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 
Secs. 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 
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 under consideration would permit a 
synfuel manufacturer (or group) to submit the results of a thorough 
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 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 non-conventional 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 in 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 
its original concerns about synfuel composition may have been 
exaggerated. Comments are also requested on whether shale-derived 
synfuels should continue to be categorized as non-baseline, even if 
fuels from other mined sources (coal, tar sands) are re-categorized as 
baseline.

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.8 
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 
testing.9 In practice, any cutoff point adopted in the regulations 
would probably function as a cap on the syncrude proportion used by 
synfuel manufacturers.
---------------------------------------------------------------------------

    \8\ This statement assumes there are no other conditions (e.g., 
high oxygen content) that would cause the fuel to be non-baseline.
    \9\ 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.
---------------------------------------------------------------------------

    As a variation on this approach, different baseline/non-baseline 
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 non-baseline. 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 
synfuels 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

[[Page 36541]]

practices which may occur as a function of the type of syncrude in 
question.

VII. De Minimis Provisions

A. Background

    In the NPRM published April 15, 1992, EPA raised the possibility of 
setting de minimis levels for some atypical F/FAs,10 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.
---------------------------------------------------------------------------

    \10\In 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.
---------------------------------------------------------------------------

    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/FA candidates and de minimis levels could be identified. Likewise, 
little data existed regarding the potential toxicities, exposures, or 
health risks associated with atypical 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 in chemical composition and rate of usage.
    EPA wishes to emphasize once again that, in proposing de minimis 
provisions 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.11 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 any affected F/FA, and to take any follow-up regulatory action 
warranted by the results.
---------------------------------------------------------------------------

    \11\ However, recent studies suggest that pulmonary injury may 
be caused by inhalation exposure to substances generally regarded as 
biologically inactive, if the exposure to such substances is in the 
form of ``ultrafine'' particles (less than 20nm). See, for example, 
Oberdorster, G., et al., ``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.
---------------------------------------------------------------------------

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 database. 12 EPA is today proposing de minimis 
provisions applicable to the following nine atypical elements:

    \12\ 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).
---------------------------------------------------------------------------

Aluminum (Al)
Boron (B)
Calcium (Ca)
Sodium (Na)
Zinc (Zn)
Magnesium (Mg)
Phosphorus (P)
Potassium (K)
Iron (Fe)

    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 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),

[[Page 36542]]

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 exposures 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 that de minimis 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 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 low-concern 
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 uncombusted 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 many samples would be needed; (3) 
once sampled, what 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?
    As discussed above, for the group of nine candidate elements, it 
appears that ambient air concentrations of at least 0.1 mg/m \3\ (100 
g/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) 
13 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 
mixture.14
---------------------------------------------------------------------------

    \13\ These measurements refer to the specified elements 
themselves, not to the weights of the compounds in which these 
elements may be bound.
    \14\ Specifically, 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.
---------------------------------------------------------------------------

    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 no atypical 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 (Sec. 79.53). 
This is the same allowance provided by the existing regulation 
(Sec. 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 measurement of individual 
emission products containing the atypical elements 
(Sec. 79.52(b)(2)(iv) and, if applicable, Sec. 79.52(b)(3)(iv)). 
Notwithstanding the de minimis provision nor any other special 
provisions for which a F/FA may 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.
    Comments on this proposal to excuse qualifying F/FAs from Tier 2 
requirements are requested. See the proposed regulatory language at 
Sec. 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

[[Page 36543]]

proposed rule. If an adverse comment or hearing request is received, 
the portion of the direct final rule at issue will be withdrawn and all 
public comments received will be addressed in a subsequent 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.

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 Sec. 79.52(c) and modify introductory paragraph 79.52(a) 
accordingly.

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 A-90-07 
located at Room M-1500, Waterside Mall (ground floor), U.S. 
Environmental Protection Agency, 401 M St. S.W., Washington, D.C. 
20460.

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 of small 
businesses.

XII. Administrative Designation

    Pursuant to Executive Order 12866 (58 FR 51735 [October 4, 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 
will reduce the requirements and costs of other parties subject to the 
regulations.

XIII. 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.

XIV. 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 rule.
    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 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.

XV. 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).

List of Subjects in 40 CFR Part 79

    Environmental protection, Fuel, Fuel additive, Gasoline, Motor 
vehicle pollution, Penalties.

    Dated: June 27, 1996.
Carol M. Browner,
Administrator.
[FR Doc. 96-17550 Filed 7-10-96; 8:45 am]
BILLING CODE 6560-50-P