P.1 

OAR Box 1165 

Prepped by Ollie Stewart 

Document Number: 

255) F. R.July 11, 1996 

Docket Number: 

A-90-07 

Printed 4/28/2008 11:52:23 AM Sheet 255 of 257 
P.12 

Federal Register / Vol. 61, No. 134 / Thursday, July 11, 1996 /Propose d Rules 3653 5 

final rules section of this Federal 

Register, the EPA is approving the 

exemption request as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

amendment and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this proposed 

rule, no further activity is contemplated 

in relation to this proposed rule. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. The EPA 

will not institute a second comment 

period on this document. Any parties 

interested in commenting on this 

document should do so at this time. 

DATES: To be considered, comments 

must be received by August 12,1996. 

ADDRESSES: Written comments on this 

action should be addressed to William 

Denman at the Environmental 

Protection Agency, Region 4 Air 

Programs Branch, 345 Courtlarid Street, 

NE, Atlanta, Georgia 30365. Copies of 

documents relative to this action are 

Dated: June 18,1996. 

A. Stanley Meiburg, 

Acting Regional Administrator. 

(FR Doc. 96-17646 Filed 7-10-96; 8:45 am] 

BILUNQ CODE 6560-60-P 

40 CFR Part 79 

[FRL-5532-6] 

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. 

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. 

£\t o be registered as fuel manufacturers available for public inspection during - - ^ A, - , . . , , , , 

normal business hours at the following ev 8*

8

 ^TJ^i° • ? ,

 P ° 

locations. The interested persons ^contro l additives into gasoline 

wanting to examine these documents 5-;

 DATES :

 Written comments on the issues 

should make an appointment with theft ? presented m this document will be 

appropriate office at least 24 hours 

before the visiting day. Reference file, 

>» >• accented u 

I 

accepted until ^Aumist 12.1996: 

ADDRESSES: Comments should be sent in 

TN167-01-9627: The Region 4 office^ k

 du Plicat e t o

 EPA

 Ai r Docke t

 Section 

ma ^ \ (LE- y have additional background 

documents not available at the other 

locations. 

Air and Radiation Docket and 

Information Center (Air Docket 6102), 

. U.S. Environmental Protection 

Agency, 401 M Street, SW., 

Washington, DC 20460. 

Environmental Protection Agency, 

Region 4 Air Programs Branch, 345 

Courtland Street, NE., Atlanta, 

Georgia 30365. William Denman, 404/ 

347-3555 extension 4208. 

Tennessee Department of Environment 

and Conservation, Division of Air 

Pollution Control, L & C Annex, 9th 

Floor, 401 Church Street, Nashville, 

Tennessee 37243-1531. 615/532-0554 

FOR FURTHER INFORMATION CONTACT: 

William Denman 404/347-3555 

extension 4208. 

SUPPLEMENTARY INFORMATION: For 

additional information see the direct 

final rule which is.published in the 

rules section of this Federal Register. 

131); Attention: Public Docket No. 

-Aj-Qn-07-Rnnm M-1500,401 MStreet 

STW., 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 

Femandes (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 Femandes 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: 

Category Examples of regulated 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 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 
P.13 

36536 Federal Register / Vol. 61 , No. 134 / Thursday, July 11, 1996 / Proposed Rules 

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 die 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. 

tiieir 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 die F/FA 

registration program without having an 

appreciable impact on its monitoring, 

control, and information collection 

objectives. 

B. Public Participation 

EPA desires full pubhc 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 pubhc hearing 

on this proposed rule. However, a 

hearing will be held if requested within 

10 days after publication. Requests for a 

pubfic hearing should be submitted in 

writing to Joseph Femandes 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 pubhc 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 pubhc without further 

notice to the commenter. 

IH. 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 § 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 § 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 EPA to define "additive" 

to clarify which products are covered by 

EPA's regulations under § 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 

subrnit 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 § 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. 

The applicable definition 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. 

The comprehensiveness of diis • 

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 
PJ4 

Federal Register / Vol. 61 , No. 134 / Thursday, July 11, 1996 / Proposed Rules 3653 7 

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 die 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 die actual 

composition of the additive products 

they buy and use. 

The transitivity of registration and 

testing requirements from additive 

manufacturers to their fuel' 

manufacturer customers has caused die 

number of parties subject to registration 

requirements to multiply and has led to 

confusion among the various parlies 

along the: F/FA production-blendingdistribution chain. It may also have 

unintended affects on the F/FA 

comrnercial 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 die 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" 

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. 

additives (defined in § 79.56(e)) state 

diat 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 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 § 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 diem into fuels were not 

considered fuel manufacturers and were 

not subject to the F/FA registration 

requirements on the basis of that 

blending activity. 

Recognizing tnat all-hydrocarbon 

substances may have toxic properties, 

the new rule removed the exclusion of 

all-hydrocarbon substances frofh the 

definition of an additive. At the time, 

EPA was particularly concerned about 

potential increased use of benzene and 

otheraromatic 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 

2

 The presence of trace contamination with 

elements other than carbon and hydrogen did not 

factor into this exclusion. 

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 tiiey blend ethanol into 

gasohne. In the case of oxygenates other 

than ethanol, die 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 fiiel 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 

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 mle 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 
36538 Federal Register / Vol. 61, No. 134 / Thursday, July 11, 1996 / Proposed Rules 

P.15 

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 tp add provisos 

to the definition of a fuel manufacturer 

(at § 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: 

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, arid 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, die 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 die 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 die 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 Cf R 79.2(k). EPA requests comments 

on the proposed changes to the 

defuMtions of "additive" and "fuel 

manafacturer." 

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 

detesgent 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 iaformation required of detergent 

additive blenders. However, if the 

definition of a fuel manufacturer is 

changed as proposed above, then 

determent 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 tkis 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 rasliion limit for manufacturers of 

atypical F/FAs (see §§ 79.58(d) (2) arid 

(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-'distributionmarketing chain, but are generally not 

3

 Of course, the additive itself must still be 

registered. 

4

 As specified in § 79.56(e)(3)(I) and (ii), nonbaseline 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 

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. 

CertificStien 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. 

included in the price paid for the fuel 

(nor in the gross sales revenue of the 

seller) until the fuel is marketed at tho 

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 fuelrelated 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 otiier 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 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 tiius, according to 

§ 79.56(e)(3)(ii)(B), fall into the nonbaseline diesel category. Furthermore, 

under § 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 
P.16 

Federal Register / Vol. 61 , No. 134 / Thursday, July 11, 1996 / Proposed Rules 3653 9 

considering a change to the grouping 

rules which would permit animal- and 

vegetable-derived biodiesel fuels to be 

grouped together.6 A 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 tiiese fuels would also be of interest. 

Section 79.56(e)(4)(ii)(B)f-?^7J 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 §§ 79.56(e)(3)(I)(B) and 

(3)(ii)(B), a ftiel derived from any 

synthetic crude source, such as shale, 

coal, or tar sands, is assigned to a nonbaseline category. The regulation does 

not specify a minimum amount of 

6

It 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 animal-derived biodiesel fuels to undergo 

separate Tier 3 testing. 

synthetic component which would 

cause a fuel to fall into the non-baseline 

category. Sections 79.56(e)(4)(ii)(A)f3j 

and (ii)(B)(3), for gasoline and diesel F/ 

FAs respectively, define separate nonbaseline groups for "formulations 

derived from each particular nonconventional 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; 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-D03) 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 

7

 Of course, this distinction is moot if the two 

activities are accomplished by the same business 

entity. 

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 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) nonbaseline 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 practicaland 

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 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 § 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 §§ 79.56(e)(4)(ii)(A)(3j 

and {ii)(B)(3) of the registration 

regulations. The inclusion in these 

sections of non-conventional processes 

in addition to non-conventional sources 
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36540 Federal Register / Vol. 61, No. 134 / Thursday, July 11, 1996 / Proposed Rules 

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 

§§ 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 nonconventional 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 nonconventional fuels into separate nonbaseline groups because of concerns that 

they were hkely 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 Tefinery 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 shalederived 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 nonbaseline 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. 

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 

pomts 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 

8

 This statement assumes there are no other 

conditions (e.g., high oxygen content) that would 

cause the fuel to be non-baseline. 

' However, under the Tier 3 provisions of tho 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. 
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Federal Register / Vol. 61 , No. 134 / Thursday, July 11, 1996 / Proposed Rules 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 otiier 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 chernical 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.'' 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 .,c 

the proposed de minimis provisions 

,0In 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. 

1

' 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. 

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 followup 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 

database.I2 EPA is today proposing de 

minimis provisions applicable to the 

following nine atypical elements: 

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), 

l2These 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). 
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36542 Federal Register / Vol. 61, No. 134 / Thursday, July 11, 1996 / Proposed Rules 

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 longterm continuous exposures to the 

general population, EPA looked at them 

only as general, relative indicators of 

potential toxicity, to be viewed in 

conjunction widi 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 pubhc 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 die 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 lowconcem 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. tie 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 

avoidsa 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 die 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 die 

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/m3 (100 ug/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., die 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 

widi 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 dial 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 

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, theedditive 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 

l3These measurements refer to the specified 

elements themselves, not to the weights of the 

compounds in which these elements may be bound. 

"Specifically, the very conservative assumption 

is made that the ambient air consists of fullypassed-through emissions of the atypical element(s) 

diluted by a factor of 1 to 2,000. 

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 requirerhents 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., die identification and measurement 

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 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 die 

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 die Testing 

Requirement for Registration 

Minor changes to the testing 

requirements are proposed.'In tile final 

rules section of this Federal Register, 

these changes are being promulgated as 

a direct final mle 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 mle. If an 

adverse comment on request for hearing 

is not received in response to the direct 

final mle, no further activity is 

contemplated in relation to this 
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Federa l Register / Vol. 61 , No. 134 / Thursday, July 11, 1996 / Proposed Rules 3654 3 

proposed rule. If an adverse comment or 

hearing request is received, the portion 

of die direct final mle at issue will be 

witiidrawn 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 § 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 anticompetitive effects are expected. A 

regulatory support document which 

presents EPA's analysis of the cost 

impacts of the May 1994 rule is 

ayailable in Pubhc 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 mle will reduce 

regulatory burdens on small businesses 

by reducing or eliminating the reporting 

and testing requirerrients for many small 

businesses. EPA has determined thatl 

this mle 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, pubhc 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 agericy; 

(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; br by the private sector, of "• 

$100 million or more. Under Section 

205, EPA must select the most costeffective and least burdensome 

alternative, that achieves the objectives 

of the rule and is consistent with 

statutory requireriients. 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 ha s 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 COOE 6S60-60-P 

DEPARTMENT OF TRANSPORTATION 

Coast Guard 

46 CFR Parts 10 and 15 

[CGD 94-055] 

RIN2115-AF23 

Licensing and Manning for Officers of 

Towing Vessels; Corrections 

AGENCY: Coast Guard, DOT. 

ACTION: Corrections to notice of 

proposed rulemaking. 

SUMMARY: This document contains 

corrections to the notice of proposed 

rulemaking (NPRM) in CGD 94-055, 

published on Wednesday, June 19, 

1996, at 61 FR 31332. The rulemaking 

relates to licensing and manning for 

officers of towing vessels. 

• DATE: These corrections are made on 

July 11,1996. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant Commander Don Darcy, 

Operating and Environmental Standards 

Division, (202) 267-0221. 

SUPPLEMENTARY INFORMATION: The 

NPRM that is the subject of these 

corrections proposes a major 

restructuring of the licensing scheme for 

officers of towing vessels. 

Need for Corrections 

As published, the NPRM contains 

typographical errors arid omissions that 

may prove to be misleading and that 

therefore need corrections.