[Federal Register Volume 61, Number 134 (Thursday, July 11, 1996)]
[Rules and Regulations]
[Pages 36506-36513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17549]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 79
[FRL-5532-4]
Registration of Fuels and Fuel Additives: Minor Changes to the
Testing Requirements for Registration
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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[[Page 36507]]
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 vehicle engines, clarify
oxygen purity 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 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 procedure 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 the direct final rule and address the comment(s) in a
subsequent final rule based on the proposed rule.
DATES: This action will be effective on August 26, 1996 unless EPA
receives an adverse comment or a request for a public hearing by August
12, 1996. If EPA receives an adverse comment or hearing request by that
date, EPA will withdraw this action via a document in the Federal
Register. All correspondence should be 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.
SUPPLEMENTARY INFORMATION:
I. Regulated Entities
Regulated categories and entities potentially affected by this
action include:
------------------------------------------------------------------------
Examples of regulated
Category entities
------------------------------------------------------------------------
Industry.................................. Manufacturers of gasoline
and diesel fuel.
Manufacturers of additives
for gasoline and diesel
fuel.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could be potentially regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your entity would be regulated by this action, you should carefully
examine this preamble and the proposed changes to the regulatory text.
You should also carefully examine the existing provisions of the
registration program at 40 CFR part 79.
II. 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, Sec. 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, and unnecessary. They argue that suitable
conditioning procedures can satisfactorily ``flush 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 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 communication 1 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.
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\1\ 1. 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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Under this revision, the requirement that only new vehicles be used
in the test program (specified in Sec. 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 adequate 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 previous testing was
restricted to F/FA types (see below) for which such test vehicle
sharing was allowed. The responsibility 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''
[[Page 36508]]
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
Sec. 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
preconditioning cycle'' was described in the technical memorandum cited
previously, and EPA has adopted this cycle, to prevent short-term
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
(Sec. 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,
Sec. 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 Sec. 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
concentrations.''
To correct this inconsistency, the language in
Sec. 79.57(e)(2)(iii)(C) is changed to account for intentional exhaust
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 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-in-
progress. 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 and days on which the minimum
exposure time has not been met.
These exposure rules 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 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 Sec. 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 Secs. 79.57(f)(3),
79.57(e)(2)(vii) and 79.61(d)(5). A new Sec. 79.63(e)(4)(iii) has been
added to emphasize the special exposure requirements of
Sec. 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 typically 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) 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 needed 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 g per
mile as the minimum threshold for identifying and reporting on a
particular PAH or NPAH compound. Similarly, Sec. 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/PCDF 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 brake-specific emissions,
would be 0.5 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 conversion factors for converting grams per mile to grams
per BHP-HR, specified in EPA Technical Report EPA-AA-SDSB-89-1.
For similar reasons, Secs. 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
[[Page 36509]]
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 tertiary-amyl-ethyl ether (TAEE) as an
unintended byproduct of ethyl-tertiary-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 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 Secs. 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 Sec. 79.51(c)(1)(ii)(B), has
been changed to ``by May 26, 2000.'' The language at the beginning of
Sec. 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 Secs. 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 in
Secs. 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.
VIII. Background Concentrations
Section 79.52(b)(l)(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 and 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)(l)(iii) is revised to clarify this and require that
only the corrected values be reported.
IX. Repetitive Driving Schedules
Section 79.57(e)(l)(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, and they include extended
engine-off times (10 minutes between bags 2 and 3 for light duty and 20
minutes between cold and hot cycles for heavy duty). While the
inclusion of cold starts and extended engine-off times are appropriate
for the certification of new vehicles and engines, these two
requirements pose significant impracticalities from the standpoint of
generating combustion 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 of 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 Sec. 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, CO2,
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 to 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 Sec. 79.57(e)(2)(iii)), 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 the animal exposures. Section
[[Page 36510]]
Sec. 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
NOX (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 vehicles and analyzed as part of the requirements for the
characterization of combustion emissions. However, the regulatory
language in Sec. 79.57(e)(1)(iii)(A) further states that ``If the mass
of particulate emissions or semi-volatile emissions 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 Sec. 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 of today's action are minimal, as
discussed above. Additionally, economic impacts are beneficial to
affected manufacturers due to the additional flexibility afforded in
today's notice. Minimal anti-competitive effects are expected. A
regulatory support document which presents EPA's analysis of the cost
impacts of the May 1994 rule is available in Public Docket A-90-07
located at Room M-1500, Waterside Mall (ground floor), U.S.
Environmental Protection Agency, 401 M St. S.W., Washington, D.C.
20460.
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 this rule will not have a
significant adverse economic impact on a substantial number of small
businesses.
XV. Administrative Designation
Pursuant to Executive Order 12866 (58 FR 51735 [October 4, 1993]),
the Agency must determine whether a regulatory action is
``significant'' and therefore subject to OMB review and the
requirements of the executive order. The order defines ``significant
regulatory actions as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local or tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this 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 defined
therein.
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
expenditure by State, local, and tribal governments, in the aggregate;
or by the private sector, of $100 million or more. Under Section 205,
EPA must select the most cost-effective and least burdensome
alternative that achieves the objectives of the rule and is consistent
with statutory requirements. Section 203 requires EPA to establish a
plan for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
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 requirements
of the Unfunded Mandates Act do not apply to this action.
XIX. 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
Environmental protection, Fuel, Fuel additive, Gasoline, Motor
vehicle pollution, Penalties.
Dated: June 27, 1996.
Carol M. Browner,
Administrator.
For the reasons set forth in the preamble, part 79 of title 40 of
the Code of Federal Regulations is amended as follows:
PART 79--[AMENDED]
1. The authority citation for part 79 continues to read as follows:
Authority: 42 U.S.C. 7414, 7524, 7545 and 7601.
2. Section 79.51 is amended by revising paragraphs (c)(1)(ii)(A),
(c)(1)(ii)(B), the first sentence of paragraphs (e)(1), (h)
introductory text,
[[Page 36511]]
(h)(1)(ii); and by adding a new paragraph (i)(4) to read as follows:
Sec. 79.51 General requirements and provisions.
* * * * *
(c) * * *
(1) * * *
(ii) * * *
(A) No later than May 27, 1997, all applicable Tier 1 and Tier 2
requirements must be submitted to EPA, pursuant to Secs. 79.52, 79.53,
and 79.59; or
(B) No later than May 27, 1997, all applicable Tier 1 requirements
(pursuant to Secs. 79.52 and 79.59), plus evidence of a contract with a
qualified laboratory (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 Sec. 79.53(c)(1). In
addition, by May 26, 2000, all applicable Tier 2 requirements (pursuant
to Secs. 79.53 and 79.59) must be submitted to EPA.
* * * * *
(e) Inspection of a testing facility. (1) A testing facility,
whether engaged in emissions analysis or health and/or welfare effects
testing under the regulations in this subpart, 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
subpart applies. * * *
* * * * *
(h) Special Requirements for Additives. When an additive is the
test subject, the following rules apply:
* * * * *
(1) * * *
(ii) Additives belonging to more than one fuel family.
(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 subpart 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 additive 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 testing of) the
respective 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.
* * * * *
(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.
* * * * *
3. Section 79.52 is amended by revising paragraphs (b)(1)(iii) and
(b)(1)(iv), (b)(2)(iii)(D) introductory text, and (b)(2)(iii)(E)
introductory text, to read as follows:
Sec. 79.52 Tier 1.
* * * * *
(b) * * *
(1) * * *
(iii) 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 Secs. 86.109-94(c)(5) and 86.135-94 of this chapter.
(iv) Concentrations of emission products shall be reported either
in units of grams per mile (g/mi) or grams per brake-horsepower/hour
(g/bhp-hr) (for chassis dynamometer and engine dynamometer test
configurations, respectively), as well as in units of weight percent of
measured total hydrocarbons.
* * * * *
(2) * * *
(iii) * * *
(D) 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 (g) 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 0.001 g per
mile (0.5 nanograms per brake-horsepower/hour) or more must be
identified, measured, and reported. The following individual species
shall be measured:
* * * * *
(E) 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 identified
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.
* * * * *
4. Section 79.57 is amended by adding paragraphs (b)(2)(i),
(b)(2)(ii), (b)(2)(iii) and (e)(1)(i)(C); and by revising paragraphs
(e)(1)(iii)(A), (e)(2)(i), (e)(2)(ii) introductory text, (e)(2)(ii)(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:
Sec. 79.57 Emission generation.
* * * * *
(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
Sec. 79.56(e)(i), and that, once a vehicle or engine has been used to
generate emissions for an atypical fuel or additive (pursuant to
Sec. 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.
(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 exhaust systems
and from the combustion emission and evaporative emission control
systems, if any.
[[Page 36512]]
(iii) Such preconditioning shall include, at a minimum, the
following steps:
(A) The canister (if any) shall be removed from the vehicle and
purged with 300 deg.F nitrogen at 20 liters per minute until the
incremental 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 deg.F shall be
performed repeatedly as necessary to achieve canister breakthrough. The
fuel tank must be drained and filled prior to each heat build.
* * * * *
(e) * * *
(1) * * *
(i) * * *
(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.
* * * * *
(iii) * * *
(A) In 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 on the characterization of
the limit of detection for particulates and semi-volatile emissions.
* * * * *
(2) * * * Generating 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).
* * * * *
(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 necessary concentration
of CO or NOX, whichever is limiting.
* * * * *
(C) 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.
* * * * *
(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
(establish in the development phase of testing) on 90 percent or more
of exposure days and that daily monitoring of CO, CO2, 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 Sec. 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 vehicles/engines cited in
paragraph (a)(7)(ii) of this section.
* * * * *
(3) * * *
(i) * * *
* * * * *
(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) * * *
(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 Sec. 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 interrupted on limited
occasions, as specified in Sec. 79.61(d)(5). Interruptions exceeding
these limitations shall cause the affected test(s) to be void.
* * * * *
5. Section 79.61 is amended by revising paragraph (d)(5) to read as
follows:
Sec. 79.61 Vehicle emissions inhalation exposure guideline.
* * * * *
(d) * * *
* * * * *
(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
[[Page 36513]]
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 652 exposure
days.
(iii) No more than two non-exposure days may occur consecutively
during the exposure period, including days on which the minimum
exposure time has not been met.
* * * * *
6. Section 79.63 is amended by adding a new paragraph (e)(4)(iii)
to read as follows:
Sec. 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.
* * * * *
7. Section 79.68 is amended by revising paragraphs (f)(1) and
(f)(5)(vi) to read as follows:
Sec. 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 brake-horsepower/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 revertant colonies per
plate, number of revertants per kilometer (or mile, or brake-
horsepower/hour), and standard deviation; and
* * * * *
[FR Doc. 96-17549 Filed 7-10-96; 8:45 am]
BILLING CODE 6560-50-P