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OAR Box 1868 

Prepped by Ollie Stewart 

Document Number: 

13) VII-A-2 

Docket Number: 

A-90-07 

Printed 11/26/2008 8:35:12 AM Sheet 13 of 258 
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y-r^: ENVIRONMENTAL PROTECTION AGENCY 

40 CFR Part 79 

[FRL - 55°><^] 

Registration of Fuels and Fuel Additives: Minor Changes to the 

Testing Requirements for Registration 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Direct ^Final /kule. 

SUMMARY: The Environmental Protection Agency ("EPA" or the 

"Agency") is issuing, as a direct final rule, minor changes to the 

health-effects testing requirements at 40 CFR Part 79, Subpart F. 

These requirements deal with the exposure of animals to evaporate 

and exhaust emissions from motor vehicles. The changes allow for 

increased flexibility in engine selection, correct an inconsistency 

with respect to mixing chamber quality assurance, establish clearer 

exposure timing requirements, provide a necessary option for the 

units in which emissions data are reported for heavy-duty /ehicie 

engines, clarify oxygen t- rity requirements, make some minor syntax 

changes, clarify the handling of the measurements of background 

chemical species in the ambient air used by the engine generating 

emissions, clarify the driving schedules, clarify the exposure 

concentration requirements in the inhalation chamber, clarify 
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dilution system requirements, and clarify, the requirements for the 

collection of particulates and semi-volatiles. These changes will 

reduce . the testing costs without affecting the environmental 

objectives. This action is being taken without prior notice 

because EPA believes that the minor changes in. the testing 

requirements will be noncontroversial. 

The rule implementing the testing requirements was finalized 

on May 27, 1994 (59 FR 33042, June 27, 1994). The test data will 

be used by the Agency to determine if the emissions of certain 

gasolines and/or diesel fuels present an unacceptable risk to 

public health. For additional background information see the 

notiosc in this issue of the Federal Register proposing changes to 

the registration regulations. The changes in this direct final 

rule have also been incorporated into that notice of proposed 

rulemaking. If an adverse comment or a request for a public 

hearing is received on this direct final rule, EPA will withdraw 

t-____p _pp-rt--i nn dmf—the direct final rule a*fc-~ iS3Ue. and address the 

comment(s) in a subsequent final rule based on the proposed rule. 

DATES: This action will be effective on [insert date 45 days after 

publication] unless EPA receives an adverse comment or a request 

for a public hearing by [insert date 30 days after publication]. 

If EPA receives an adverse comment or hearing request by that date, 

EPA will withdraw the—applicable—portion—oi\ this action via a 

»otio€. in the Federal Register. All correspondence should be 

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directed to the addresses below. 

ADDRESSES: Materials relevant to this rulemaking have been placed 

in Docket A-90-07. The docket is located at the U.S. Environmental 

Protection Agency, Air Docket Section (LE-131), 401 M Street, S.W., 

Washington, DC 20460 in Room M-1500 of Waterside Mall. Documents 

may be inspected between the hours of 8:00 a.m. and 5:30 p.m., 

Monday through Friday. A reasonable fee may be charged for 

copying. Those"wishing to notify EPA of their intent to submit an 

adverse comment or request a public hearing should contact Joseph 

Fernandes (202) 233-9756 or Jim Caldwell (202) 233-9303 at the EPA. 

FOR FURTHER INFORMATION CONTACT: Joseph Fernandes (202) 233-9756 or 

Jim Caldwell (202) 233-9303, USEPA, Office of Mobile Sources, Fuels 

and Energy Division,- Mail Code 6406J, 401 M Street, S.W., 

Washington, DC 20460. 
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SUPPLEMENTARY INFORMATION: 

I. Regulated Entities 

Regulated categories and entities potentially affected by this 

action include: 

Category Examples of regulated entities 

Industry Manufacturers of gasoline and 

diesei 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 
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CFR part 79. 

II. Background 

For program background, see the notice in this issue of the 

Federal Register proposing non-minor changes to the registration 

regulations for fuels and fuel additives (F/FA). The changes to 

the testing requirements in this direct final rule are minor and 

noncontroversial. 

III. Requirements for New Vehicles/Engines 

To ensure that the tests conducted' on the emissions of one 

F/FA are not affected by "carryover" emissions from other F/FAs 

previously used in the test vehicle, § 79.57 of the registration 

regulations requires that a new vehicle or engine be used in the 

testing of each F/FA. The regulations also recommend that one or 

more identical new vehicles or engines be acquired as backup 

emission generators for each F/FA. 

The regulated industry has commented to EPA that this 

requirement is burdensome, expensive, ard unnecessary They argue 

that suitable conditioning procedures can satisfactorily "fi^dh 

out" the remnants of one F/FA and its emissions, so that the. same 

vehicle or engine can be used in testing another F/FA without fear 

of carryover effects. If this were permitted, a substantially 
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smaller fleet of initial test vehicles/engines might suffice for a 

given series of F/FAs. Also, a relatively small number of 

additional vehicles could be acquired to serve as shared backups 

for the,testing of more than one F/FA. 

A previous technical communication1 discussed in detail the 

possibility of short-term and long-term carryover effects due to 

test vehicles/engines being used for multiple F/FAs. It also 

described the restrictions and procedural safeguards which could,be 

adopted to minimize potential carryover problems. Based on that 

earlier discussion, EPA believes it is now appropriate to ease some 

of the restrictions on test vehicle use in some circumstances. 

Under this revision, the requirement that only new vehicles be 

used in the test program (specified in § 79.57(a) (1)) has been, 

retained, since it would not be possible to know how, and with what 

range of F/FA products, a vehicle had been operated in general use. 

However, it is now acceptable for a single test vehicle or engine, 

to be used sequentially by different F/FA manufacturers for tests 

on different F/FAs, assuming that adeguate documentation is 

furnished to demonstrate that the test vehicle/engine had not been 

used for purposes other than testing under this program and that 

such pres ious te.

 u'.ng was restricted to F/FA type_» (see uelow) for 

which such test vehicle sharing was allowed. The responsibility 

\ l / Memo to Docket A-90-07 from James D. Greaves, "A 

Preconditioning Cycle for Potential Use in the Fuels and Fuel 

Additives Registration Program," 1992 (Docket Item II-B-8). 
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for assuring the adequacy of such documentation falls to the fuel 

manufacturer who secondarily acquires the test vehicle. 

As discussed in the previously-cited technical memorandum, 

concerns about, possible long-term carryover effects arise primarily 

in regard to "atypical" elements. Consistent with that discussion, 

EPA believes that the current prohibition against using test 

vehicles/engines for more than one F/FA should be retained in the 

case of atypical F/FAs. However, in the case of F/FAs which belong 

to the same fuel family (as defined in § 79.56(e)(1)) and which 

contain no elements other than carbon, hydrogen, oxygen, nitrogen, 

and sulfur, EPA believes that long-term carryover effects are of 

minimal concern, and thus believes that it is acceptable to permit 

test vehicles to be used for more than one such F/FA. Thus, for 

example, a given test vehicle/engine could be used in testing base 

gasoline and one or more nonbaseline gasoline formulations. A 

vehicle that had been used for baseline and/or nonbaseline gasoline 

testing may be used in testing one a typical F/FA formulation, but 

may not subsequently be used for additional baseline/nonbaseline 

F/FA testing nor for testing of other atypical F/FAs. 

To prevent short-term carryover effects, a preconditioning 

procedure is,required to "flush out", the remnants of a previously 

tested F/FA and its emissions from a vehicle's, fuel system, engine, 

exhaust, system, and emission control system, before that vehicle is 

used in the testing of another F/FA. A suitable "intermediate 
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preconditioning cycle" was described in the technical memorandum 

cited previously, and EPA has adopted this cycle, to prevent shortterm carryover effects between tested F/FAs. Section 79.52(b)(2) 

is revised accordingly. 

IV. Mixing Chamber Quality Assurance 

The method specified in the F/FA program regulations for 

generating combustion emissions to be used in biological testing (§ 

79.57(e) (2)) requires a mixing chamber or other apparatus to smooth 

out the variability in emission concentrations related to 

transient-cycle operations. As a quality assurance mechanism, § 

79.57(e) (2) (iii)(C) states that this apparatus "must function such 

that the average concentration of total hydrocarbons leaving the 

apparatus shall be within 10 percent of the average concentration 

of hydrocarbons entering the chamber." EPA has noted that this 

language is inconsistent with § 79.57(e) (2) (iv) (C) , which allows 

intentional dilution of the exhaust stream to occur "in the mixing 

chamber (and/or after leaving the chamber) to achieve the desired 

biological exposure concent._-•*•*.tions. " 

To correct this inconsistency, the language in 

§79.57(e) (2) (iii) (C) is changed to account for intentional exhau_t 

dilution. Specifically, the following phrase has been added to the 

end of the provision cited above: "... , taking into account any 

further intentional dilution occurring in the apparatus pursuant to 

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paragraph (e)(2)(iv)(C) of this section." 

V. Exposure Interruptions 

Section 79.57(e) (2) (vii) of the regulations specifies how long 

biological exposures may be interrupted without voiding a test-iriprogress. EPA has received feedback from the regulated industry 

that the language in this section is confusing and that, 

furthermore, it is inconsistent with customary laboratory 

practices. EPA agrees with this criticism and has revised the 

cited section, substituting new exposure time requirements. 

Specifically, EPA has incorporated into the regulations the 

following minimum requirements: 1) A daily exposure must be at 

least 6 hours plus the time necessary to build the chamber 

atmosphere to 90 percent of the target exposure atmosphere; 2) A 

day in which the minimum exposure time has not been achieved does 

not count as an exposure day; 3) Exposures must be conducted at 

least 4 days per week; 4) No more than two non-exposure days may 

occur consecutively during the exposure period, including weekends 

i • * . 

and days on which the minimum exposure time has not been met. 

These exposure iv~.es purposely do not make allowance for 

Federal holidays. EPA believes that additional "down" days for 

holidays could impact the results of the 90-day test periods 

required under Tier 2, and could interfere with EPA's ability to 
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compare the results with other F/FAs tested during cycles in which 

holidays did not occur. Furthermore, if a particular health 

effects test guideline contains exposure requirements that differ 

from these general rules, then the specific requirements would take 

precedence. An example is the Fertility and Teratology assessment 

at §79.63(c)(1), which requires exposures to pregnant animal 

subjects each day during the first 15 days of gestation. 

Under this change, biological tests which did not achieve 

exposures consistent with the above rules would be considered void. 

The same rules would be applied to both evaporative emission and 

exhaust emission tests. See the revised language at §§ 

79.57(f)(3), 79.57(e)(2)(vii) and 79.61(d)(5). A new 

§79.63(e) (4) (iii) has been added to emphasize the special exposure 

requirements of §79.63(c)(1). 

VI. Units for Reporting Emissions Data 

Section 79.52(b)(1)(iv) specifies that manufacturers report 

emissions data in units of grams per mile and weight percent total 

hydrocarbons. These units are cypically used to report emissions 

data from light-duty vehicles operating on chassis dynamometers, 

but may be inappropriate for reporting emissions data from other 

engine/vehicle classes operating on engine dynamometers. As such, 

the wording of paragraph 79.52(b) (1) (iv) has been changed to 

specify that F/FA manufacturers should use brake-specific emission 

values in units of grams per brake-horsepower/hour (gm/BHP-HR) 

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where these units are .appropriate to the emissions test 

configuration and the vehicle/engine being tested. 

If brake-specific emissions data are reported, then 

corresponding changes are need at several other points in the 

regulations. Section 79.52(b) (2) (iii) (D) specified that the 

concentration of individual polyaromatic hydrocarbons (PAHs) and 

nitrated-polyaromatic hydrocarbons (NPAHs) identified in Tier 1 

emissions analyses shall be reported only in units of microgram 

(/_g) per mile, with 0.001 p.g per mile as the minimum threshold for 

identifying and reporting on a particular PAH or NPAH compound. 

Similarly, §79.52 (b) (2) (iii) (E) specified that the concentration of 

each polychlorinated dibenzodioxin/polychlorinated dibenzofuran 

(PCDD/PCDF) identified in the Tier 1 emissions stream shall be 

reported in units of picograms (pg) per mile, with 0.5 pg per mile 

or more as the minimum threshold for identifying and reporting on 

a particular PCDD/PGDF compound. 

These sections have been revised to allow reporting of PAH, 

NPAH, and PCDD/PCDF emissions data in units of grams per BHP-HR/ 

where appropriate. The counterpart to the g/mile reporting 

threshold for PAH and NPAH compounds, expressed in terms of brakespecific emissions, would be 0.3 nanograms per BHP-HR or more. 

Likewise, the counterpart to the g/mile reporting threshold for 

PCDD/PCDF compounds would be 0.3 pg per BHP-HR or more. These 

counterpart values were derived by applying fleet average 

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conversion factors for converting grams per mile to grams per BHPHR, specified in EPA Technical Report EPA-AA-SDSB-89-1. 

For similar reasons, §§ 79.68(f)(1) and (f) (5) (vi) of the 

Salmonella typhimurium reverse mutation assay guidelines have been 

modified to permit data from this assay to be presented in units of 

either revertants per kilometer (mile) or revertants per BHP-HR, 

whichever is appropriate to the case at hand. 

VII. Oxygenate Purity 

Section 79.51(i) specifies that a fuel manufacturer who 

reports the potential use of more than one oxygenating additive in 

his non-baseline fuel is responsible for testing (or participating 

in group testing) of a separate fuel formulation for each such 

oxygenating additive. This provision has caused some concern that 

the occurrence in an oxygenate additive of unintended oxygenate 

byproducts of the manufacturing process could multiply the testing 

responsibilities of a fuel manufacturer. For example, concern has 

been expressed that the occurrence of a small amount of tertiaryamyl-ethyl ether (TAEE) as an unintended byproduct of ethyltertiary-butyl ether (ETBE) production will affect the grouping of 

an ETBE additive and will cause a fuel manufacturer who blends ETBE 

into his fuel to be responsible for testing TAEE as well as ETBE 

(see docket item VI-D-10) . This was not EPA's intention in 

promulgating this provision. Section §79.51(i)(4) has been revised 

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to state that small amounts of unintended oxygenate compounds 

occurring as byproducts of the manufacturing process of an 

oxygenating additive do not affect the grouping of the affected 

F/FAs nor the testing responsibilities of their manufacturers. 

E. Minor Syntax Changes and Clarifications 

Minor changes to the regulations are also needed to correct 

some specific syntax errors. The phrase "Within May 27, 1997," 

occurring at the beginning of both §§ 79.51(c)(1)(ii)(A) and (B), 

has been changed to "No later than May 27, 1997". Similarly, the 

phrase "within May 26, 2000," occurring within § 

79.51(c) (1) (ii) (B) , has been changed to "by May 26, 2000." The 

language at the beginning of § 79.51(e) (1), which read, "A testing 

facility, emissions analysis or health and/or welfare effects, 

shall permit..." has been changed to: "A testing facility, whether 

engaged in emissions analysis or health and/or welfare effects 

testing under these regulations, shall permit..." Some of the 

wording in §§ 79.'57(e) (2) (i) , (2) (ii) (2) (ii).(B) , (3) (i) , and 

(3)(i)(A) has been changed to clarify the driving schedules to be 

used when operating the vehicle or engine to generate combustion 

emissions for biological testing. The wording ir fj 79.51(h), 

(h)(1) (ii), and (h) (1) (ii) (A) and (B) dealing with additives 

belonging to more than one fuel family, has been revised to make 

this provision easier to understand, without changing the substance 

of the requirements. ' . 

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VIII. Background Concentrations 

Section 79.52(b) (1) (iii) requires that the ambient/dilution 

air to the engine generating emissions for characterization be 

analyzed for levels of background chemical species present at the 

time of emission sampling (for both combustion arid, evaporative 

emissions). These background chemical species concentrations are 

to be reported with emissions speciation data. This information is 

necessary so that it can be subtracted from the measured combustion 

and evaporative concentrations in order to determine the 

contribution for the F/FA. Section 79.52(b)(1)(iii) is revised to 

clarify this and require that only the corrected values be 

reported. 

IX. Repetitive Driving Schedules 

Section 79.57(e)(1)(I) requires the Light-Duty Urban 

Dynamometer Driving Schedule (UDDS.) or the Heavy Duty Engine 

Dynamometer Schedule (EDS) as per 40 CFR Part 86. Both of these 

driving schedules require cold starts at the beginning of the 

cycle, arid they include extended engine-off times (10 minutes 

between b?jS 2 "nd 3 for light duly __nd 20 minutes brcween cold and 

hot cycles for hea*/y duty) . While the inclusion of cold starts and 

extended engine-off times are appropriate for the certification of 

new vehicles and engines, these two reguirements pose significant 

impracticalities from the standpoint of generating combustion 

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emissions for animal exposures. 

First, if the. UDDS were repeated as per the, new vehicle 

certification procedure, an eight hour animal exposure would 

require 24 engines sequenced for a cold start every 20 minutes. 

Second, the engine-off time requirements from the certification 

procedure typically involve extended periods of zero emissions. If 

these were incorporated into the Tier 2 biological testing, the 

later requirements for a "settling chamber" which will dampen out 

transients to the point that exposure concentrations are held 

constant within'± 10%, would result in the need for a huge settling 

chamber. • 

Thus it is appropriate to allow the engine used for animal 

exposures to be operated over repeated "hot" driving cycles. This 

would entail repeated Bags 2 and 3 oaf the UDDS for light-duty 

vehicles and back-to-back repeats of the heavy-duty transient cycle 

for heavy-duty engines. Both of these should be run without 

extended idles or engine-off periods. 

Repeated operation of the engine over the hot portions (bags 

2 and 3) of the FTP will avoid the extended engine-off periods 

which do not contribute anything to animal exposure. This would 

minimize the transients in the species concentrations, and reduce 

the need for a large settling chamber, without changing the nature 

of the species present for the animal exposure. A new § 

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79.57(e)(1)(i)(C) has been added to reflect this. 

X. Exposure Concentration 

Section 79.57(e)(2)(vi)(B) requires that the mean exposure 

concentration in the inhalation chamber be within 10 percent of the 

target concentration on 90 percent or more of the days. This 

implies that target concentrations must be established for CO, C02, 

NOx, SOx, and total HC, and none can vary by more than 10% of the 

targets on 90% or more of the exposure days. Given the 

fundamentals of engine combustion and the transient nature of the 

driving cycles, it is impossible to maintain all combustion 

emission products at a constant level all of the time. The focus 

should be on the pollutants which are limiting for the animals in 

terms of exposure, which is CO for gasoline and NOx for diesel. 

The engine operator will only be able to vary the exhaust dilution 

ratio, and thus control is assured for only one pollutant (CO or 

NOx) at a time. Section 79.57 (e) (2) (vi) (B) has been revised 

accordingly. 

• 

XI. Dilution System 

Section 79.57(e)(2) (I) states that the biological tests are LO 

be performed "...using emissions generated from the test vehicle or 

engine operated in general accordance with the FTP procedures cited 

in this section." Later in this section (at §79.57(e)(2)(iii)), 

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the regulations state that "An apparatues to integrate the large 

concentration swings typical of transient-cycle exhaust is to be 

used between the FTP-Constant Volume Sampler (CVS) source of 

emissions and the exposure chamber containing the animal test 

cages." These statements imply that a CVS is required to be used 

as a first stage of dilution in the delivery of combustion 

emissions for animal exposure. However, we have received a comment 

that the dilution needed for gasoline blends and for diesel fuels 

will be more than can be accomplished with a CVS. Therefore, the 

test laboratory should not be, required to use a CVS as a first 

stage of dilution. In fact, it may be most practical to use a 

constant dilution (rather than volume) sampler to minimize 

transient concentrations for tha animal exposures. Section 

§79.57 (e) (2) (iii) has been revised to allow the use of any dilution 

system design that achieves the necessary concentration of CO or 

N0X (whichever is limiting) and reduces transient concentration 

exposure. 

XII. Collection of Particulates and Semi-volatiles 

Section 79.57(e)(1)(ii) states that emissions of particulates 

and semi-volatiles are to be collected over triplicate FTP tests 

for light-duty vehicle: and analyzed as part of the requirements 

for the characterization of combustion emissions. However, the 

regulatory language in §79.57 (e) (1) (iii) (A) further states that "If 

the mass of particulate emissions or semi-volatile emissions 

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obtained during one driving cycle is not sufficient for 

characterization, then the driving cycle may be performed again and 

the extracted fractions combined prior to chemical analysis." The 

number of driving cycles that "may be performed" is left unclear 

and potentially conflicts with the triplicate FTP requirements. We 

have received a comment that the available literature on gasoline 

blends suggests that the amount of particulate and semi-volatile 

emissions collected from one FTP test on a light-duty vehicle is 

extremely minute, if not less than the detection limits afforded by 

measurement and analytical procedures currently in use. Thus 

§79.57(e) (1) (iii) (A) has been revised to clarify that no more than 

the three FTP tests are required to be performed for the collection 

of particulate and semi-volatile emissions. . And, the test 

laboratory should focus on the characterization of the limit 

detection for particulates and semi-volatile emissions. 

XIII. Environmental and Economic Impacts 

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

discussed above. Additionally, economic impacts are beneficial to 

affected manufacturers due to the additional flexibility afforded 

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

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

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

•18 
Environmental Protection Agency, 401 M St. S.W., Washington, D.C. 

20460. ' 

XIV. Regulatory Flexibility Analysis 

EPA has determined that it is not necessary to prepare a 

regulatory flexibility analysis in connection, with this final 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 this1rule will not 

have a significant adverse economic impact on a substantial number 

of small businesses. 

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environmental Protectiori Agency, 401 M St. S.W., Washington, D.C> 

20460. 

XIV. Compliance with the^-Kegulatory Flexibility Act 

s ' •/ ' \ 

s^ k^ 

The Regulatory Flexibility Act (RFA) ofW^ O requires federal 

agencies/to examine the effects of^their regulations and to 

identify and significant impa^rtfs of those regulations on a 

s^ibstantial number of sma^lr entities. Pursuant to section 605(b) 

of the Regulatory /Flexibility Act, 5 U.S.C. 605(b), the 

Administrator certifies that this rule will not have a_^s-r«fnificant 

adverse economic impact on a substantial numb^j?^of small entities, 

In fact, it will reduce ' costs by^ simplying the testing 

requirements, 

XXlP Administrative Designation 

# 

Pursuant to Executive Order 12866<f(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 

V f^Vb 

19 (X-
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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 direct final rule is not a "significant 

regulatory action". The regulatory revisions in this notice will 

reduce testing the requirements and costs. 

XVI. 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 

20 
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define d the.r_e.irij. 

XVII. Submission To Congress and the General Accounting Office 

Under section 801(a) (1) (A) of the, Administrative Procedures 

Act (APA) as amended by the Small Business Regulatory Enforcement 

Fairness Act of 1996, EPA submitted report containing this rule and 

other required information to the U.S. Senate, the U.S. House of 

Representatives and the Comptroller General of the General 

Accounting Office prior to publication of the rule in today's 

Federal Register. The rule is not a "major rule" as defined by 

section 804(2) of the APA as amended. 

XVIII. 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 

vexpenditure 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 estabx.'-.h a plan for informing and advising any 

. small governments that may be significantly or uniquely impacted by 

the rule. * 

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The Agency 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 requiremerits of the 

Unfunded Mandates Act do not apply to this action. 

22 
$ • 

Registration of 

Page [2: 

Fuel Additives, Direct Final Rule --

[42]. 

VUG 

TBTTTIJQ statutory Authority 

The statutory authority for this direct final 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 

Fuel, Fuel additive, Gasoline, Motor vehicle pollution, 

Penaltiestf) 1'imorpoidLlOii by^ Ref eroncerCDated: JUN 27 

Administrator(A 'XJr^ v. 

For the reasons set forth i. che preamble, part 79 of /Title 40 

of the Code of Federal Regulation is amended as follows: 

vL 

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P.26 

1. The authority citation for part 79 continues to read as 

follows:

 N 

( 

Authority: 42 U.S.C. 7414, 7524, 7545 and 7601. 

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2. Section 79.51 is amended by revising paragraphs (c) (1) (ii) (A), 

(c) (1) (ii) .(B).,, .^.he first sentence of paragraph (e) (1), (h) 

introductory text, -(h) (1) (ii) ; and by adding a new paragraph (i) (4) 

to read as follows: 

N<-

2 5 
P.28 

2. Section . 7,9.. 51 is . amend 

>ws 

-f-,_4 *£±+ 

an£ (B)/to .ad rollows 

y revisin g paragraphs (c)(1)(ii)(A) 

I 79.51 General requirements and provisions. 6) 

(c) 

(i)fm—*—-*• -»JL 4F 

(ii) LPor thes e products, th e manufacturor rnuot als o satisfy—kL__ 

t h r rnqii i ul ti • Irul I lllir—bcheduleo—ru e'iLher of th o following Q . 

f^rMjY'U^hu li'll-Ufi'i'WJI I rn- In. o f fchia Hftfitio___J-P_ 

(A) No later than May 27, 1997, all applicable Tier 1 and 

Tier 2 requirements must be submitted to EPA, pursuant to §§ 79.52, 

79.53, and 79.59;/or 

(B) No later than May 27, 1997, all applicable Tier 1 

requirements (pursuant to §§ 79.52 and 79.59), plus evidence of a 

contrac, with i qualified - Moratory (or other suitable 

arrangement) for completion of all. applicable Tier 2 requirements, 

must.be submitted to EPA. For this purpose, a qualified laboratory 

is one which can demonstrate the capabilities and credentials 

specified in § 79.53(c)(1).. In addition, by May 26, 2000, all 

25(^ 
P.29 

applicable Tier^ 2 requirements (pursuant to §§ 79.53 and 79.59) 

must be submitted to EPA. 

3. Section 79.51 is also amendedby revising the first sentence of 

paragraph (e) (1) to reaoV^HSfrollows: 

S 79.51 /ueneral requirements and provisions, 

**** * 

(e) Inspection of a testing facility. (1) A testing 

facility, whether engaged in emissions analysis or health and/or 

welfare effects testing under these regulations, shall permit an 

authorized employee or duly designated representative of EPA, at 

reasonable times and in a reasonable manner, to inspect the 

facility and to inspect (and in the case of records also to copy) 

all records and specimens required to be maintained regarding 

studies to which this rule applies. ¥r ¥: ^k 

26 
P.30 

4. Section 79.51 is also amended by revising^tft'e introductory text 

to paragraph (h) as well as paragraph (h)(1)'(ii) to read as 

follows: 

i 79.51 Genpfal requirements and.provisions 

* * * * * 

(h) • Special Requirements for Additives. When an additive is 

the test subject, the following rules apply: 

**** * 

•(*fTi 

i) Additives belonging to more than one fuel family. 

\rf S U 

(A) If an additive product is registered in two or.more fuel 

families as of May 27, 1994,' then the manufacturer of that additive 

is responsible for testing (or participating in group testing of) 

the respective additive/base fuel mixtures in compliance with the 

requirements of this sub^-irt for each fuel family in which the 

manufacturer wishes to maintain a registration for its additive. 

(B) If a manufacturer is seeking to register such additi e in 

two or more fuel families then, for testing and registration 

purposes, the additive shall be considered to be a member of each 

fuel family in which the manufacturer is seeking registration. The 

manufacturer is responsible for testing (or participating in group 

/. 

27 
P.31 

testing of) thejrespective additive/base fuel-mixture in compliance 

with the requirements of this subpart for each fuel family in which 

the manufacturer wishes to obtain a product registration .for its 

additive. 

28 
P.32 

(i) # 

-<** _ 

(4) The presence in a particular oxygenating additive of small 

amounts of other unintended oxygenate compounds as byproducts of 

the manufacturing process of the given oxygenating additive does 

not affect the grouping of that additive and does not . create 

multiple testing responsibilities for manufacturers who blend that 

additive into fuel. 

29 
P.33 

1 f « Section 79.52 is amended by revising paragraphs (b) (1) (iii) and 

(b) (1) (iv) , _-as—welt—al ETTe^ iniiuduuluiy—fr •T-o-rf .t*-- paragraphf. P 

(b) (2) (iii) (D)£and (b) (2) (iii) (E)A to read ,as follows: 

S 79.52 Tier 1. 

J 

* * * * 

NF 

(b) Y-BmiiJglOllO Cha^rrpr-i stationl**^ 

^-* ^ 

.(•arTtiii ) Measurement of background emissions: It is required 

that ambient/dilution air be analyzed for levels of background 

chemical species present at the time of emissions sampling (for 

both combustion and evaporative emissions) and that sample values 

be corrected by substracting the concentrations contributed by the 

ambient/dilution air. Background chemical species 

measurement/analysis during the FTP is specified in §§ 86.109-

94(c)(5) and 86.135-94 of this chapter. 

WTU(iv/ ) Concentrations of emission products shall be reported 

either in units of grams per mile (g/mi) or grams per brakehorsepower/hour (g/bhp-hr) (ft chassis dynamometer and engine 

dynamometer test configurations, respectively) , as well as in units 

of weight percent of measured total hydrocarbons. 

30 
P.34 

(2-H*Wu)) The analytical method used to measure species of 

PAHs and NPAHs should be capable of detecting at least 1 ppm 

(equivalent to 0.001 microgram (pg) of compound per milligram of 

organic extract) of these compounds in the extractable organic 

matter. The concentration of each individual PAH or NPAH compound 

identified shall be reported in units of microgram per mile or 

nanograms per brake-horsepower/hour (for chassis dynamometer and 

engine dynamometer test configurations, respectively). Each 

compound which is present at d.001 pg per mile (0.5 nanograms per 

brake-horsepower/hour) or more must be identified, measured, and 

reported. The following individual species shall be measured: 

\JL 

(^44iJ-iTtE) The analytical method used to measure species and 

classes of PCDD/PCDFs should be capable of detecting at least 1 

part per trillion (ppt) (equivalent to 0.001 picogram (pg) of 

compound per milligram of organic extract) of these compounds in 

the extractable organic matter. The concentration of each 

individual PCDD/PCDF compound identif ied shall be reported in units 

of picograms (pg). per mile or picograms per brake-horsepower/hour 

(for chassis dynamometer and engine dynamometer test 

configurations, respectively). Each compound which is present at 

0.5 pg/mile (0.3 pg/bhp-hr) or more must be identified, measured, 

and reported. 

=k&&fr% 

31 
P.35 

4. Section 79.57 is amended by. adding paragraphs (b) (2) (i) 

(b) (2) (ii), (b).L2) (iii)/; and by revising paragraphs (e) (1) (iii) (A), 

(&) (1) (i) (D ,() . (e)(2) (i), (e) (2) (ii) introductory text, 

(e) (2) (iij (B) , (e) (2) (iii) introductory text, (e) (2) (iii)'(C) , 

(e) (2) (vi) (B) , (e)(2) (vii), (e) (3) (i) (A) , and (f)(3); and by 

revising the word "cycle" to read "schedule" in paragraph (e) (3) (i) 

introductory text; to read as follows: 

§ 79.57 Emission generation. ve/rc 

**** * 

(b) * * * • ' . . 

(2) *"**' ' .' 

(i) A vehicle or engine may be used to generate emissions for 

the testing of more than one fuel or additive, provided that all 

such fuels and additives belong to the same fuel family pursuant to 

§ 79.56(e) (i) , and that, once a vehicle pr engine has been used' to 

generate emissions for an atypical fuel or additive (pursuant to § 

79.56(e) (2).(iii))', it shall not be used in the testing of any other 

fuel or additive. Paragraphs (a)(2) and (3) of this section shall 

apply only to the first fuel, or additive tested. 

JL 

try 
\fi-l-J

' 

M;, W Section 79^57 is amended by re^iTsing^paragcaphs. (b)(2), and 

(ii) Prior to being used to generate emissions for testing an 

additional fuel or additive, a vehicle^ or engine which has 

previously been used for testing a different fuel or additive shall 

undergo an effective intermediate preconditioning cycle to remove 

the previously used fuel and its emissions from the vehicle's fuel 

and exv__ust _- -s ;ems and fron the combustif^ emi^-ion and 

evaporative emission control systems, if any. 

(iii) Such preconditioning shall include, at a minimum, the 

following, steps: . 

32 o^ 
P.37 

(A) The canister (if any) shall be removed from the vehicle 

and purged with 300° F nitrogen at 20 liters per minute until the 

iricremental weight loss of the canister is less than 1 gram in 30 

minutes. This typically takes 3-4 hours and removes 100 to 120 

grams of adsorbed gasoline vapors. 

(B) The fuel tank shall be drained and filled to capacity 

with the new test fuel or additive/fuel mixture. 

(C) The vehicle or engine shall be operated until at least 

95% of the fuel tank capacity'is consumed. 

• 

(D) The purged canister shall be returned to the vehicle. 

(E) The fuel tank shall be drained and filled to 40% capacity 

with test fuel. 

(F) Two-hour fuel tank heat builds from 72°-120° F shall be 

performed* repeatedly as necessary to achieve canister breakthrough. 

The fuel tank must be drained and filled prior to each heat build. 

33 
*•=—* " 

CO-*** 

(lltci^C) For Tier 2 testing, the engines shall operate on 

repeated bags 2 and 3 of the UDDS or back to back repeats of the 

heavy-duty transient cycle of the EDS. 

\Jy) ^fatrif-(Af m the case of combustion emissions generated from 

light-duty vehicles/engines, the samples consist of three bags of 

vapor emissions (one from each segment of the light-duty exhaust 

emission cycle) plus one sample of particulate-phase emissions and 

one sample of semi-volatile-phase emissions (collected over all 

segments of the exhaust emission cycle). If the mass of 

particulate emissions or semi-volatile emissions obtained during 

one driving cycle is not sufficient for characterization, up to 

three driving cycles may be performed and the extracted fractions 

combined prior to chemical analysis. Particulate-phase emissions 

shall not be combined with semi-volatile-phase emissions. The test 

laboratory should focus oi_ the characterization of the limit of 

detection for particulates arid semi-volatile emissions. 

>f&-a*-*yX ^ _^- —__ _ 4-

Section 79.57 i 

C. 

(e) (2) (i) , (e)(2)(ii ) 

(e) (2) (vi) (B) , (e>W) (vii) , (e) (3) (i)/? 

rea d a s fc 

amended by revisin c 

(2)(ii)(B) , (e)(2 ) 

LOWS 

rag r pa s 

a^ Ve-*-." 

) (iii ) (O , 

(A), and (f)(3) , t o 

34 
P.39 

(2)[jGenerating whole combustion emissions for biological 

[testing, (i) Biological tests requiring whole combustion 

emissions shall be conducted using emissions generated 

from the test vehicle or engine operated in accordance 

with general FTP requirements. 

*—--*—*—*— * •**••«— -

(ii) Light-duty test vehicles/engines shall be repeatedly 

operated over the Urban Dynamometer Driving Schedule (UDDS) (or 

equivalent engine dynamometer trace, per paragraph (e)(1)(i)(A) of 

this section) and heavy-duty test engines shall be repeatedly 

operated over the Engine Dynamometer Schedule (EDS) (see 40 CFR 

part 86, appendix I). 

# 

(4d)(B) The UDDS or EDS shall be repeated as many times as 

required for the biological test session. 

(iii) An apparatus to integrate the large concentration 

swings typical of transient-cycle exhaust is to be used.between the 

source of emissions and the exposure chamber containing the animal 

test cages(s). The purpose of such apparatus is to decrease the 

variability of the biological exposure atmosphere and achieve the 

35 
necessary concentration of CO or N0X, whichever is limiting. 

The mixing chamber (or any alternative emission 

moderation apparatus) must function such that the average 

concentration of total hydrocarbons leaving the apparatus shall be 

within 10 percent of the average concentration of hydrocarbons 

entering the chamber, taking into account any further intentional 

dilution occurring in the apparatus pursuant to paragraph 

(e)(2)(iv)(C) of this section. fl 

ir—*—•* r^r-* *••— 

' • r ***-. P 

(vi)/(B) These procedures include requirements that the mean 

exposure concentration in the inhalation test chamber shall be 

within 10 percent of the target concentration for the single 

species being controlled (established in the development phase of 

testing) on 90 percent or more of exposure days and that daily 

monitoring of CO, C02, NOx, SOx, and total hydrocarbons in the 

exposure chamber shall be required. Analysis of the particle size 

distribution shall also be performed to established the stability 

and consistency of particle size distribution in the test .exposure. 

(vii) To allow for customary laboratory scheduling and 

unforeseen problems affecting the combustion emission generation or 

dilution equipment, biological exposures may be interrupted on 

limited occasions, as specified in' § 79.61(d)(5). Interruptions 

exceeding these limitations shall cause the affected test(s) to be 

void. Testers shall be aware of concerns for backup 

36 
P.41 

vehicles/engines cited in paragraph (a)(7)(ii) of this section. 

**** * 

37 
( 3 ) *_*_* . • 

(i) jy- salmonell a mutagenicity testing-; pursuant—to -g—?-9-~&8-,—•••? • 

§hatirirhe uundilcted on extracts of the particulat e and m__ui volatil u - P t 

emission phaoeo oeparatoly-.—Thooo emissions shal l bil uene_e**dt_ad by— ^ 

opeiaLiuq Lhe Lest vehicle/engine over Lhu auui'Qbtfiate FTP drivin g ^ ^ 

schedulefje*H \— —~*- **~ ^*0 \c 

° • • * . * 

(A) Particulate emissions shall be collected on particulate 

filters and extracted from the collection equipment for use in 

biological tests. The number of repetitions of the applicable 

driving schedule required to collect sufficient quantities of the 

particulate emissions will vary, depending on the characteristics 

of the engine., the test fuel, and the requirements of the 

biological test protocol. The particulate sample may be collected 

on one or more filters, as necessary. 

**** * 

(f) * * * 

•F-—-ir * ir 

38 
P.43 

(3) For biological testing, vapor shall be withdrawn from the. 

EEG at a constant rate, diluted with air as required for the 

particular study, and conducted immediately to the biological 

testing chamber (s) in a manner similar to the method used in § 

79.57(e), excluding the mixing chamber therein. The rate, of 

emission generation shall be high enough to supply the biological 

exposure chamber with sufficient emissions to allow for a minimum 

of fifteen air changes per exposure chamber per hour. To allow for. 

customary laboratory scheduling and for unforeseen problems with 

the evaporative emission generation or dilution equipment, 

biological exposures may be iriterrupted on limited occasions, as 

specified in § 79.61(d)(5). Interruptions exceeding these 

limitations shall cause the affected test(s) to be void. 

• * * * * 

A-fl-

£~ \^Q &-£ Section 79.61 is amended by revising paragraph (d) (5) to read 

as follows: 

S 79.61 Vehicle emissions inhalation exposure guideline. 

**** * 

(d) * * * 

39 
P.44 

• I 

(5) Exposure Conditions. The preferred exposure regimen 

consists of exposing the study animals to the test atmosphere on a 

repeated basis for at least 6 hours per day on a 7-day per week 

basis for the exposure period. However, unless precluded by the 

requirements of a particular test protocol, exposures based on a 

nominal 5-day-per-week regimen will be considered acceptable, 

subject to the following rules: 

(i) Each daily exposure during the exposure period must be at 

least 6 hours, plus the time necessary to build the chamber 

atmosphere to 90 percent of the target exposure atmosphere. A day 

in which this minimum exposure time has not been achieved does not 

count as an exposure day. 

(ii) Nominally, animal exposures should be conducted for six 

hours per day for five days per week. In no case should the 

exposures occur less than four days per week for a total of 65 ± 2 

exposure days. 

(iii) No more than two non-exposure days may occur 

consecutively a-" ing the exposur- period, including da}J on which 

the minimum exposure time has not been met. 

40 
P.45 

• •*..• » 

V L&-^ ^ Section 79.63 is amended by insertrrng*--a new paragraph 

(e) (4) (iii) to read as follows 

8 79.63 Fertility assessment/teratology. 

* * * * . * 

^ 

(e) * * * 

^ (4) * * * 

(iii) Pregnant females shall be exposed to the test 

atmosphere on each and every day between (and including) the first 

and fifteenth day of gestation. 

^-*V^ 

41 
P.46 

t ~ . 

__. q±3/e? Section 79.68 is amended by revisin g paragraphs (f)(1) and 

/ " /__ \ /_• . t.ml \ •, . , __ _ _ *__ 1 1 -

^ 

(f) (5),(vi) to read as follows 

,Q \<(_^,. 8 79.68 Salmonella typhimurium reverse mutation assay. 

* * * * * 

' (f) Data and report (1) Treatment of results. Data 

shall be presented as number of revertant colonies per plate, 

revertants per kilogram (or liter) of fuel, and as revertants per 

kilometer (or mile, or brake-horsepower/hour, as appropriate) for 

each replicate and dose. These same measures shall be recorded on 

both the negative and positive control plates. The mean number of 

revertant colonies per plate, revertants per kilogram (or liter) of 

fuel, and revertants per kilometer (or mile, or brakehorsepower/hour), as well as individual plate counts and standard 

deviations shall be presented for the test substance, positive 

control, and negative control plates. 

(5) 

\ ~ 

(vi) Individual plate counts, mean number of revei -?nt 

colonies per plate, number of revertants per kilometer (or mile, or 

brake-horsepower/hour), and standard deviation; and 

w w- w w w