involve clarifying vague or inconsistent language, removal or updating
of outdated provisions, and decreasing the frequency and/or volume of
reporting burden where data is either no longer needed or is redundant
in light of other EPA fuels programs. In general, we believe that these
changes would reduce burden on industry with no expected environmental
impact. We believe that the regulatory streamlining items that we are
proposing are changes that are straightforward and that should be made
quickly. There are also additional items that would need further
consideration and discussion, such as a new fuels program compliance
structure, as discussed below in Section VI.A.1.b. We are also
requesting comment on expanding the downstream butane blending
provisions to allow for pentane blending, as discussed in Section
VI.A.4.
1. Regulatory Streamlining
a. Summary of Proposed Amendments
    Below is a table listing the provisions that we are proposing to
amend in today's action. We have provided additional explanation for
those amendments that warrant additional explanation below.

                Table VI-1--Summary of Proposed Regulatory Streamlining and Technical Amendments
----------------------------------------------------------------------------------------------------------------
                  Section                                                Description
----------------------------------------------------------------------------------------------------------------
Varied.....................................  Various sections amended to update references to test methods (see
                                              Section Section VI.A.1.a.iii).
79.5.......................................  Revises periodic reporting requirements.
80.2.......................................  Revises and adds definitions.
80.8.......................................  Amended to update sampling test methods, and to state to which
                                              fuels Sec.   80.8 applies.
80.10......................................  Added to allow for de minimis changes in compliance reports that
                                              would not require a resubmission of compliance reports when a
                                              minor discrepancy of a few barrels is uncovered.
80.46......................................  Revises measurement of RFG fuel parameters.
80.47......................................  Revises Performance-Based Test Method Approach.
80.65......................................  Amended to reduce complex model test parameters and reporting.
80.65(f)(5)................................  Added to allow for designation of an alternative lab.
80.75......................................  Revises RFG reporting requirements.
80.82......................................  Amended to apply butane blending provisions to entire part 80 and
                                              to revise RVP test method.
80.101.....................................  Revises measurement of conventional gasoline fuel parameters.
80.105.....................................  Amended to require identification of test methods used and revises
                                              reporting requirements.
80.161(b)(1)(ii)(A)(2).....................  Amended to allow an alternative gasoline detergent certification
                                              option.
80.161(b)(1)(ii)(A)(3).....................  Added to allow an alternative detergent certification option.
80.161(b)(2)...............................  Amended to address the submission of gasoline detergent samples
                                              under the alternative gasoline detergent certification option.
80.161(b)(3)(ii)(C)........................  Amended to reflect that documentation of the fuel injector deposit
                                              demonstration test would be required under the alternative
                                              detergent certification option.
80.161(b)(3)(v)............................  Amended to state that the results of the intake valve and fuel
                                              injector deposit demonstration test must be submitted to EPA as
                                              part of the certification letter under the alternative detergent
                                              certification option.
80.161(b)(3)(viii).........................  Amended to change ``PFID test'' to ``fuel injector test''.
80.161(d)(1)...............................  Amended to reflect the availability of the alternative gasoline
                                              detergent certification option.
80.163(a)(1)(iii)..........................  Amended to allow use of the alternative gasoline detergent
                                              certification option.
80.164(a)..................................  Amended to reference the test fuel requirements under the
                                              alternative gasoline detergent certification option.
80.165.....................................  Amended the introductory paragraph to accommodate the alternative
                                              deposit control test procedures and standards under the
                                              alternative gasoline detergent certification option.
80.167(a)..................................  Amended the introductory paragraph to specify how confirmatory
                                              testing would be conducted for additives certified under the
                                              alternative gasoline detergent certification option.
80.176.....................................  Added to specify the certification test procedures and standards
                                              under the alternative gasoline detergent certification option.
80.177.....................................  Added to specify the certification test fuels under the alternative
                                              gasoline detergent certification option.
80.178.....................................  Incorporates standards and test methods by reference.
80.330.....................................  Revises sampling and testing requirements.
80.370.....................................  Amended to require identification of test method used and revises
                                              reporting requirements.
80.511.....................................  Revises per-gallon and marker requirements.
80.572.....................................  Revises labeling requirements.
80.573.....................................  Revises labeling requirements.
80.574.....................................  Revises labeling requirements.

80.580.....................................  Incorporates test methods by reference.
80.585.....................................  Revises test method approval process.
80.604.....................................  Revises reporting requirements.
80.1235(a)(6),.............................  Amended to allow refiners and importers who are blending blendstock
                                              into previously certified gasoline (PCG) an alternative to
                                              directly test the blendstock for benzene.
80.1235(a)(5)..............................  Amended to clarify that refiners and importers may use either
                                              approach for blendstocks that are blended into either conventional
                                              gasoline or reformulated gasoline.
80.1235(b)(2)..............................  Amended to clarify EPA's intent (per Sec.   80.1238(b)) to allow
                                              refiners and importers to include oxygenate blended downstream of
                                              a refinery or import facility in their annual average benzene
                                              calculation, and to make the section consistent with Sec.
                                              80.1238(b).
80.1238....................................  Revises benzene determination.
80.1347(a)(5)..............................  Amended to require that a negative annual average must be reported
                                              as zero, and that a refiner must comply with Sec.   80.65(i) when
                                              producing RBOB or RFG and Sec.   80.101(g)(9) when producing
                                              conventional gasoline.
80.1347(a)(6)..............................  Added to allow refiners and importers who are blending blendstock
                                              into previously certified gasoline (PCG) an alternative to
                                              directly test the blendstock for benzene.
80.1348....................................  Revises sample retention requirements.
80.1349....................................  Added to allow importers who import gasoline into the U.S. by truck
                                              to use the sampling and testing requirements in 40 CFR part 80
                                              subpart E as an alternative to the sampling and testing
                                              requirements in subpart L.
80.1354....................................  Revises reporting requirements for gasoline benzene program.
80.1451....................................  Revises RFS reporting requirements.
----------------------------------------------------------------------------------------------------------------

i. Amendments Related to Reduction of Testing for Complex Model Fuel
Parameters
    In Sec. Sec.  80.65 and 80.75, we are proposing to streamline and
reduce the RFG and CG testing and reporting burden of gasoline refiners
and importers by reducing the testing and reporting requirements of
certain fuel parameters associated with the complex model. Currently,
for RFG, every parameter listed in Sec.  80.65 must be tested for every
batch and each parameter must be reported for every batch. No monthly
compositing of batch samples is allowed for any parameter. For
conventional gasoline, monthly compositing and batch reporting based on
those monthly composites is allowed for all parameters except sulfur
and benzene. However, with the phasing out of complex model standards,
reduced testing and reporting is appropriate, particularly for RFG. In
cases where a refiner is subject to only benzene, RVP, and sulfur
standards, certain parameters no longer need to be tested and reported
on an every-batch basis. However, the full slate of complex model
parameters will still be needed in some cases. Specifically, refiners
producing RFG during the summer VOC control season will still need to
use the complex model to determine VOC performance, and thus must still
measure and report the relevant complex model fuel parameters. In
addition, small refiners that are subject to the delayed compliance
option for the 0.62 volume percent benzene standard will have to use
the complex model until 2015 for CG MSAT1 compliance.\402\ Currently,
there are 17 complex model parameters on the RFG/anti-dumping batch
report. We are proposing to eliminate reporting for American Petroleum
Institute (API) gravity. In addition, oxygenates need not be reported
unless the refiner's gasoline includes oxygenates or the refiner is
including downstream added oxygenate in its compliance calculations.
Apart from being necessary for use in the complex model, these
parameters have little use for program compliance. In addition, we are
proposing to reduce testing and reporting as follows: For both RFG and
conventional gasoline we propose to eliminate the requirement to test
and report API gravity for batch certification purposes. For winter
RFG, we propose to eliminate the requirement to test and report the
following parameters on an every batch basis and instead allow testing
and reporting of monthly composites: aromatics, distillations and
olefins. Winter sulfur and benzene would continue to be tested and
reported on an every batch basis. All summer complex model parameters
would still be required to be tested and reported on an every batch
basis. For conventional gasoline, since the regulations already allow
for testing and reporting most parameters on a monthly composite basis,
the only significant change would be to eliminate the batch
certification testing and reporting for API gravity. Only benzene,
sulfur, and any oxygenates that are actually included in the gasoline
batch must be tested and reported on an every-batch basis (except for
refiners that are still subject to a complex model toxics standard;
they must test all parameters but may use monthly composite testing and
reporting except for sulfur and benzene, and oxygenate, where
applicable). The values for aromatics, olefins, and distillation terms
may continue to be determined from monthly composites. These changes
would substantially reduce the testing and reporting associated with
each batch. We request comment on this reduced testing scheme.
---------------------------------------------------------------------------

    \402\ 61 FR 17230 (March 29, 2001).
---------------------------------------------------------------------------

ii. Amendments Related to Reporting
    EPA is proposing to amend various provisions in 40 CFR parts 79 and
80 to reduce the number of different reporting deadlines that regulated
parties must meet and to enable the future use of a unified and
simplified reporting form. EPA's goal is to simplify reporting and
reduce the number of hours parties spend preparing and submitting
reports. This overall effort responds to Executive Orders 13563 and
13610, which direct government agencies to simplify rules and to
achieve reductions in paperwork and reporting burdens, and is part of
EPA's agency-wide effort to streamline regulatory reporting
requirements.
    Currently under 40 CFR parts 79 and 80, there are ten separate
cyclical reporting dates each year (eleven in a leap year). This
proposal would amend these deadlines so that all affected programs use
the same four dates. Programs that would be affected by this proposal
include the fuels and fuel additives registration program (40 CFR part
79, subpart A), the Reformulated Gasoline and Anti-Dumping program (40
CFR part 80, subparts D and E), the Gasoline Sulfur program (40 CFR
part 80 subpart H), the Motor Vehicle, Nonroad, Locomotive, and Marine
Diesel program (40 CFR part 80 subpart

I), the Gasoline Benzene program (40 CFR part 80 subpart L), and the
Renewable Fuel Standard program (40 CFR part 80 subparts K and M). We
are proposing that reporting deadlines would be standardized as
follows: June 1, for all reports covering quarter 1 of the compliance
year; September 1, for quarter 2; December 1, for quarter 3; and March
31 for quarter 4. End of year compliance reports would also be due on
March 31.
    These proposed changes would either delay or maintain current
deadlines for nearly all required reports. Deadlines for all other
annual reports would either be maintained if they matched the new
quarterly deadline, or extended to match the new quarterly deadline.
    These proposed changes would not include ``Attest Engagements'' or
reporting related to specific events under the Fuels Program, such as
trading Renewable Identification Numbers (RINS) in EPA's Moderated
Transaction System (EMTS). All reporting deadlines for Attest
Engagements and reporting specific events would remain the same.
    Respondents would still have the option to report earlier than any
given deadline. Additionally, these deadline changes would allow EPA to
develop a single electronic format that would collect all required data
and maximize the capability of electronic reporting with data reuse, no
duplicate fields, and a user-friendly interface.
    We would also be correcting a typographical error in 40 CFR
80.1451(f)(2) and clarifying that reports are to be signed by the
``responsible corporate officer.'' Additionally, we would remove an
incorrect reference under 79.5(a)(2).
iii. Amendments To Update Test Methods
    Refiners, importers and oxygenate blenders producing gasoline and
diesel motor vehicle fuel are required to test RFG, CG and diesel fuel
for various fuel parameters including aromatics, benzene, distillation,
olefins, oxygenate content, RVP, and sulfur. A number of relevant
regulatory provisions currently have references to test methods that
have since been revised and updated. We are proposing to update those
test methods to reflect current test methods in order to ensure that
all test methods are readily available to the regulated community. ASTM
International (ASTM) test method D2622 is currently the designated test
method for measuring sulfur (Sec. Sec.  80.46(a)(1), 80.580(b)(2)), in
gasoline and diesel fuel at the 500 ppm sulfur standard. ASTM test
methods D5453, D6920, D3120 and D7039 are currently alternative test
methods for measuring sulfur (Sec. Sec.  80.46(a)(3)(i),
80.46(a)(3)(ii), 80.46(a)(3)(iii), 80.46(a)(3)(iv)) in gasoline. ASTM
test method D5453 is also alternative test method for measuring sulfur
(Sec.  80.580(c)(2)) in diesel fuel at the 500 ppm sulfur standard, as
well as ASTM test method D4294. ASTM test method D6667 is currently the
designated test method for measuring sulfur (Sec.  80.46 (a)(2)) in
butane. ASTM test methods D4468 and D3246 are currently alternative
test methods for measuring the sulfur (Sec.  80.46(a)(4)(i),
80.46(a)(4)(ii)) content in butane. ASTM D1319 is currently the
designated test method for measuring olefins (Sec.  80.46(b)) in
gasoline and aromatics (Sec.  80.2(z)) in diesel fuel and is also
allowed as an alternative test method for measuring aromatics (Sec.
80.46(f)(3)) in gasoline. ASTM D6550 is currently an alternative test
method for measuring olefins (Sec.  80.46(b)(2)(i)) in gasoline. ASTM
test method D5599 is currently the designated test method for measuring
oxygenates (Sec.  80.46(g)(1)) in gasoline. ASTM test method D4815 is
currently an alternative test method for measuring oxygenates (Sec.
80.46(g)(2)) in gasoline. ASTM test method D5769 is currently the
designated test method for measuring aromatics (Sec.  80.46(f)(1)) in
gasoline. ASTM test method D3606 is currently the designated test
method for measuring benzene (Sec.  80.46(e)) in gasoline. ASTM test
method D86 is currently the designated test method for measuring the
distillation (Sec.  80.46(d)) of gasoline. ASTM test method D5191 is
currently the designated test method for measuring the RVP (Sec.
80.46(c)) of gasoline. ASTM test method D976 is currently the
designated test method for measuring the Cetane Index (Sec.  80.2(w))
of diesel fuel. ASTM standard practice D4057 is currently the manual
sampling standard practice for petroleum and petroleum products (Sec.
80.8(a)). ASTM standard practice D4177 is currently the automatic
sampling standard practice for petroleum and petroleum products (Sec.
80.8(b)). ASTM standard practice D5842 is currently the RVP sampling
standard practice for fuels (Sec.  80.8(c)). ASTM standard practice
D5854 is currently the composite sampling standard practice for
petroleum and petroleum products (Sec.  80.8(a)).
    Table VI-2 lists the designated analytical test methods and
alternative analytical test methods for RFG, CG and diesel fuel that we
are proposing to update in today's action. The Agency has reviewed
these updated ASTM test methods and believes that the revisions
contained in them will result in improvements in the utilization of
these test methods for the regulated industry. We also believe that our
proposal to revise these test methods would not result in significant
changes that would cause a user of an older version of the same method
to incur increased compliance costs. Moreover, all of the revisions
were deemed necessary by ASTM International so that improvements in the
test method's procedures would ensure better operation for the user of
the test method. Thus, EPA is proposing today to update the regulations
for the following ASTM test methods: (1) ASTM D2622-10, the designated
test method for measuring sulfur in RFG, CG, and alternative test
method for diesel fuel at the 500 ppm sulfur standard; (2) ASTM D3120-
08, alternative test method for sulfur in gasoline, ASTM D4294-10,
alternative test method for sulfur in diesel fuel at the 500 ppm sulfur
standard; (3) ASTM D5453-09, alternative test method for sulfur in
gasoline and diesel fuel at the 500 ppm sulfur standard; (4) ASTM
D6667-10, designated test method for sulfur in butane; (5) ASTM D4468-
85(2006), alternative test method for sulfur in butane; (6) ASTM D3246-
11, alternative test method for sulfur in butane; (7) ASTM D1319-10,
designated test method for measuring olefins in gasoline and aromatics
in diesel fuel, as well as the alternative test method for measuring
aromatics in gasoline; (8) ASTM D6550-10, alternative test method for
measuring olefin content in gasoline; (9) ASTM D4815-09, alternative
test method for measuring oxygenate content in gasoline; (10) ASTM
D5599-00(2010), the designated test method for measuring oxygen content
in gasoline; (11) ASTM D5769-10, the designated test method for
measuring aromatics in gasoline; (12) ASTM D3606-10, the designated
test method for measuring benzene in gasoline; (13) ASTM D86-11a, the
designated test method for measuring distillation properties of
gasoline; (14) ASTM D5191-10b, the designated test method for measuring
the RVP of gasoline; (15) ASTM D976-06(2011), the designated test
method for measuring the Cetane Index of diesel fuel; (16) ASTM D4057-
06(2011), the manual sampling standard practice for petroleum and
petroleum products; (17) ASTM D4177-95(2010), the automatic sampling
standard practice for petroleum and petroleum products; (18) ASTM
D5842-04(2009), the sampling standard practice for RVP of fuels; and
(19) ASTM D5854-96(2010), the

composite sampling standard practice for petroleum and petroleum
products.

 Table VI-2--Proposed Designated & Alternative ASTM International Analytical Test Methods Under RFG, CG & Diesel
                                           Motor Vehicle Fuel Programs
----------------------------------------------------------------------------------------------------------------
               Fuel parameter                                     ASTM analytical test method
----------------------------------------------------------------------------------------------------------------
Sulfur (gasoline)...........................  ASTM D2622-10, entitled ``Standard Test Method for Sulfur in
                                               Petroleum Products by Wavelength Dispersive X-Ray Fluorescence
                                               Spectrometry.''
Sulfur (500 ppm diesel).....................  ASTM D2622-10, entitled ``Standard Test Method for Sulfur in
                                               Petroleum Products by Wavelength Dispersive X-Ray Fluorescence
                                               Spectrometry''
Sulfur (gasoline)...........................  ASTM D5453-09, entitled, ``Standard Test Method for Determination
                                               of Total Sulfur in Light Hydrocarbons, Spark Ignition Engine
                                               Fuel, Diesel Engine Fuel, and Engine Oil by Ultraviolet
                                               Fluorescence.''
Sulfur (500 ppm sulfur diesel)..............  ASTM D5453-09, entitled, ``Standard Test Method for Determination
                                               of Total Sulfur in Light Hydrocarbons, Spark Ignition Engine
                                               Fuel, Diesel Engine Fuel, and Engine Oil by Ultraviolet
                                               Fluorescence.''
Sulfur (gasoline)...........................  ASTM D3120-08, entitled, ``Standard Test Method for Trace
                                               Quantities of Sulfur in Light Petroleum Hydrocarbons by Oxidative
                                               Microcoulometry.''
Sulfur (500 ppm sulfur diesel)..............  ASTM D4294-10, entitled, ``Standard Test Method for Sulfur in
                                               Petroleum Products by Energy Dispersive Xray Fluorescence
                                               Spectrometry.''
Sulfur (butane).............................  ASTM D6667-10, entitled, ``Standard Test Method for Determination
                                               of Total Volatile Sulfur in Gaseous Hydrocarbons and Liquefied
                                               Petroleum Gases by Ultraviolet Fluorescence.''
Sulfur (butane).............................  ASTM D4468-85(2006), entitled, ``Standard Test Method for Total
                                               Sulfur in Gaseous Fuels by Hydrogenolysis and Rateometric
                                               Colorimetry.''
Sulfur (butane).............................  ASTM D3246-11, entitled, ``Standard Test Method for Sulfur in
                                               Petroleum Gas by Oxidative Microcoulometry.''
Oxygen content (gasoline)...................  ASTM D5599-00(2010), entitled, ``Standard Test Method for
                                               Determination of Oxygenates in Gasoline by Gas Chromatography and
                                               Oxygen Selective Flame Ionization Detection.''
Oxygen content (gasoline)...................  ASTM D4815-09, entitled ``Standard Test Method for Determination
                                               of MTBE, ETBE, TAME, DIPE, tertiary-Amyl Alcohol and C1 to C4
                                               Alcohols in Gasoline by Gas Chromatography.''
Olefins (gasoline)..........................  ASTM D1319-10, entitled ``Standard Test Method for Hydrocarbon
                                               Types in Liquid Petroleum Products by Fluorescent Indicator
                                               Adsorption.''
Olefins (gasoline)..........................  ASTM D6550-10, entitled, ``Standard Test Method for the
                                               Determination of Olefin Content of Gasolines by Supercritical-
                                               Fluid Chromatography.''
Aromatics (gasoline and diesel).............  ASTM D1319-10, entitled ``Standard Test Method for Hydrocarbon
                                               Types in Liquid Petroleum Products by Fluorescent Indicator
                                               Absorption,'' for diesel fuel, this method is the designated test
                                               method; for gasoline, this method is an alternative test method
                                               and if used as an alternative method, its results must be
                                               correlated to ASTM D5769.
Aromatics (gasoline)........................  ASTM D5769-10, entitled, ``Standard Test Method for Determination
                                               of Benzene, Toluene, and Total Aromatics in Finished Gasolines by
                                               Gas Chromatography/Mass Spectrometry.''
Benzene (gasoline)..........................  ASTM D3606-10, entitled, ``Standard Test Method for Determination
                                               of Benzene and Toluene in Finished Motor and Aviation Gasoline by
                                               Gas Chromatography.''
Distillation (gasoline).....................  ASTM D86-11a, entitled, ``Standard Test Method for Distillation of
                                               Petroleum Products at Atmospheric Pressure.''
Reid Vapor Pressure (gasoline)..............  ASTM D5191-10b, entitled, ``Standard Test Method for Vapor
                                               Pressure of Petroleum Products (Mini-Method).''
Cetane Index (diesel).......................  ASTM D976-06(2011), entitled, ``Standard Test Method for
                                               Calculated Cetane Index of Distillate Fuels.''
Manual Sampling of Petroleum and Petroleum    ASTM D4057-06(Reapproved 2011), entitled, ``Standard Practice for
 Products.                                     Manual Sampling of Petroleum and Petroleum Products.''
Automatic Sampling of Petroleum and           ASTM D4177-95(Reapproved 2010), entitled, ``Standard Practice for
 Petroleum Products.                           Automatic Sampling of Petroleum and Petroleum Products.''
RVP Sampling for Fuels......................  ASTM D5842-04(Reapproved 2009), entitled, ``Standard Practice for
                                               Sampling and Handling of Fuels for Volatility Measurement.''
Composite Sampling of Petroleum and           ASTM D5854-96(Reapproved 2010), entitled, ``Standard Practice for
 Petroleum Products.                           Mixing and Handling of Liquid Samples of Petroleum and Petroleum
                                               Products.''
----------------------------------------------------------------------------------------------------------------

iv. Amendments Related to Downstream Blending
    Today's proposed rule also clarifies the list of products that are
not to be included in a refinery's or importer's compliance
determination under Sec.  80.1240. Refiners and importers are currently
required under Sec.  80.1235(b)(2) to exclude oxygenate added to
finished gasoline, RBOB or CBOB downstream of either the refinery that
produced the gasoline or the import facility where the gasoline was
imported. This conflicts with EPA's intended approach in Sec.
80.1238(b), which allows refiners and importers to include oxygenate
blended downstream of a refinery or import facility in their annual
average benzene calculation, provided the refiner or importer meets
certain requirements. We are proposing changes that would allow
refiners and importers to include oxygenate blended downstream of their
facility and that would make these related sections consistent.
v. Amendments for Previously Certified Gasoline
    For benzene, we would also provide flexibility for refiners and
importers by providing an alternative allowing them to directly sample
and test each batch of blendstock, and treat the blendstock as the
produced batch for blendstock that is blended into previously certified
gasoline (PCG). We are proposing to add Sec.  80.1347(a)(6) to reflect
this alternative. This practice is already allowed under the Tier 2
sulfur program (at

Sec.  80.340(a)(2)). Refiners and importers are currently required to
test the PCG for benzene before addition of blendstock, test the
combined blend of PCG and blendstock for benzene, and calculate the
properties of the blendstock by treating the PCG as a negative volume
batch and treating the blended product as a positive batch. Due to
variability in the benzene test method, the PCG approach can sometimes
result in calculated blendstock benzene concentrations that are
negative, which is physically impossible. We are proposing to amend the
regulations at Sec.  80.1235(a)(6) (and add Sec.  80.1347(a)(6), as
mentioned) to allow refiners and importers that blend blendstock into
PCG an alternative to directly test the blendstock for benzene. We
expect that this would ensure a positive benzene test result. Also,
today's proposal would clarify that regardless of the approach used, a
negative sulfur or benzene result cannot be reported; rather, any
negative result must be rounded to zero. Similarly, no negative annual
average result can be reported. We are also proposing to amend the
regulations at Sec.  80.1235(a)(5) to clarify that refiners and
importers may use either approach for blendstocks that are blended into
either conventional gasoline or reformulated gasoline.
    Lastly, we are proposing to allow importers who import gasoline
into the United States by truck to use the sampling and testing
requirements in subpart E for truck importers as an alternative to the
sampling and testing requirements in subpart L. EPA provided these
alternative requirements in subpart E to eliminate the need to test
every truckload of imported conventional gasoline for all complex model
parameters, including benzene.\403\ Since Subpart L also requires
importers to test every truckload of imported gasoline for benzene, EPA
believes it is appropriate to allow truck importers of gasoline to use
the sampling and testing requirements in subpart E as an alternative.
Today's rule proposes to amend the regulations to provide this
alternative by adding a new Sec.  80.1349.
---------------------------------------------------------------------------

    \403\ 70 FR 74561 (December 15, 2005).
---------------------------------------------------------------------------

vi. Amendments Related to Designation of an Alternative Lab
    Refiners have indicated to EPA that significant problems are
created when a facility's designated lab is nonoperational and testing
cannot be performed at the lab during that time period. We are thus
proposing (at Sec.  80.65(f)(5)) that a facility have the ability to
designate a back-up or alternative lab for testing during such times.
In no case could this alternative lab be used to select the best test
result, rather it could only be used on those occasions where
operational necessity causes a need for it (e.g., the normal lab is
closed, the apparatus for certain test methods are down, or independent
lab personnel are not available).
vii. Amendments Related to De Minimis Reporting Changes
    We are proposing for the correction of batch volume reports to
allow for de minimis changes in reporting compliance that would not
require a complete resubmission of compliance reports when a minor
discrepancy of a few barrels is uncovered. This allowance for the
correction of batch volume reports would apply to reporting for: RFG,
anti-dumping, gasoline and diesel sulfur, MSAT2 and the RFS renewable
volume obligation (RVO) (for RFS, this would only apply to the volume
of fuels produced or exported that result in a RVO for obligated
parties). We are proposing a new section 80.10 to define de minimis,
for the purpose of this allowance, as no more than 500 gallons or by no
more than 1 percent of the true batch volume in gallons, whichever
value is less. We request comment on whether or not a different amount
would be more appropriate.
viii. Amendments Related to RFS2 Annual Report Date
    Currently, the RFS2 final reporting date (last day of February)
coincides with the RFG and Anti-dumping compliance deadline, which
creates a staffing problem for regulated entities because the
regulatory requirements are often handled by the same personnel. It was
reported to EPA that this also creates an issue when small
discrepancies in gasoline production or import volumes are realized,
and can potentially trigger an increased RFS RVO and an ensuing
scramble to obtain the necessary Renewable Identification Numbers
(RINs) in real time. Delaying the RFS reporting date until after
volumetric auditing would address this situation and would have no
impact on emissions, air quality or compliance with the standard. As
such, we are proposing to change the RFS2 reporting date in Sec.
80.1451 to March 31. EPA is also seeking comment on whether the ability
to transfer RINs in EMTS for satisfying RVOs under the previous
compliance year should be extended from the last day of February to
March 31 as well.
ix. Acceptance of Alternate Test Data Under the Gasoline Deposit
Control Program
    The ``Top Tier'' deposit control gasoline standards developed by
four major automakers are based on the premise that a more robust level
of the control of vehicle engine and fuel systems beyond that provided
by the EPA deposit control requirements is desirable.\404\ Several
major gasoline marketers have adopted Top Tier for their gasoline. It
is widely accepted that conformance with the Top Tier intake valve
deposit (IVD) and fuel injector deposit (FID) control testing
requirements is more challenging than complying with the EPA IVD and
FID testing requirements. Yet additive packages must still be certified
to EPA's less stringent standards on older test procedures. We believe
that EPA could accept IVD/FID test data that complies with the Top Tier
requirements in place of IVD/FID data that complies with the current
EPA testing requirements without jeopardizing the emissions benefits
from EPA's deposit control program. We are proposing that test data
that complies with the Top Tier IVD performance standards at section
1.3.1 could be used to satisfy EPA's IVD control requirements. We are
also proposing that test data that complies with the Top Tier FID
performance testing standards at section 1.3.3 could be used to satisfy
EPA's FID control requirements. We believe that this allowance would
provide significant saving to industry from reduced deposit control
testing while maintaining the emissions benefits of EPA's gasoline
deposit control program. These changes are being proposed in the
regulations at Sec. Sec.  80.161(b), 80.163(a)(1)(iii), 80.164(a),
80.165, 80.167(a), 80.176, and 80.177.
---------------------------------------------------------------------------

    \404\ The industry established ``Top Tier'' deposit control
standards can be found at http://www.toptiergas.com/deposit_control.html. EPA's deposit control requirements are contained in
Sec. Sec.  80.140 through 80.174.
---------------------------------------------------------------------------

b. Broader Regulatory Streamlining Through Program Restructuring
    The current set of fuel regulations is the result of programs that
have been established over the years to reduce emissions from mobile
sources. These programs include gasoline volatility (RVP), reformulated
gasoline and anti-dumping, sulfur control (which the Tier 3 program
proposed today would revise), mobile source air toxics (MSAT1), benzene
control (MSAT2), and the renewable fuel standards (RFS). Most of these
regulations have been amended numerous times.

    The RFG and anti-dumping regulations in particular contain some of
the more burdensome requirements on sampling, testing, and reporting.
They also have some of the more stringent restrictions on gasoline use
(e.g., restricting where fuel produced can be sold, what it may be
commingled with, etc.). EPA used the RFG and anti-dumping rules as the
foundation for many aspects of subsequently developed fuel regulatory
programs. However, the subsequent rules, considered as a whole, have
supplanted most of the RFG and anti-dumping standards. For this reason,
we are proposing to streamline the regulations in several places as
described above. Initial discussions with fuel industry representatives
have indicated that a comprehensive review of the complete set of fuel
regulations contained in Parts 79 and 80 (``Registration of Fuels and
Fuel Additives'' and ``Regulation of Fuels and Fuel Additives,''
respectively) of the Code of Federal Regulations could lead to further
streamlining of the regulations beyond the streamlining provisions
proposed today.
    EPA expects that streamlining would result in more efficient and
less costly compliance determinations for affected parties while
maintaining the environmental benefits of the programs. Since such
changes could require not just the removal or streamlining of existing
provisions but also the replacement of several provisions with new,
less onerous ones, we are not proposing such changes today. However,
EPA requests comments on potential areas in the fuel regulations that
may benefit from such a more comprehensive streamlining effort. For
example, it may be possible for the RFG VOC standard to be met if a
sufficiently stringent RVP level is attained. Under this scenario,
sampling and testing requirements at the refinery would be reduced.
Another potential scenario could involve consolidation of some RFG and
anti-dumping rules; for example, a single set of rules governing the
treatment of downstream ethanol blending and in-use surveys could
provide greater efficiency and flexibility regarding fuel distribution.
2. Subpart I Technical Amendments

                     Table VI-3--40 CFR Part 80 Subpart I (Diesel Fuel) Technical Amendments
----------------------------------------------------------------------------------------------------------------
                  Section                                                Description
----------------------------------------------------------------------------------------------------------------
80.572(a)..................................  Amended to remove the requirement for 15 ppm highway diesel fuel
                                              pump labels beginning November 30, 2014, and to amend the title to
                                              reflect that the section includes labeling requirements for
                                              dispensers of motor vehicle diesel fuel.
80.584(b)(3)(i)............................  Amended to correct typographical error (``notc'' to ``not'').
----------------------------------------------------------------------------------------------------------------

    We are proposing to remove the requirement for diesel fuel pump
labels for 15 ppm highway diesel fuel. Beginning December 1, 2010, all
highway diesel fuel was required to be 15 ppm or less; thus, highway
diesel fuel labels are no longer needed to distinguish it from 500 ppm
highway diesel fuel. However, we do recognize that it may confuse
consumers who are accustomed to seeing the highway diesel fuel pump
labels if those labels were to disappear, so we are also requesting
comment on the removal of this labeling requirement. Note that if
highway diesel fuel pump labels are no longer required by the
regulations, retail and wholesale purchaser-consumer facilities would
be free to continue labeling to eliminate confusion if they so choose.
3. Performance-Based Measurement Systems (PBMS)

                                  Table VI-4--PBMS-Related Technical Amendments
----------------------------------------------------------------------------------------------------------------
                   Section                                                Description
----------------------------------------------------------------------------------------------------------------
80.46.......................................  Amended to allow for performance-based approaches for measuring
                                               gasoline parameters.
80.47.......................................  Added to extend the performance-based approach to other parameters
                                               besides diesel sulfur.
80.101(i)(1)(i)(A),(i)(3)(i)(C),              Amended to allow for performance-based approaches for measuring
 (i)(3)(ii)(C).                                gasoline parameters.
80.330(c)(1), (d)(1), (d)(2)................  Amended to allow for performance-based approaches for sampling and
                                               testing.
80.370(a)(7)(iv)............................  Amended to require identification of the test method used to
                                               measure the sulfur content of a batch.
80.585(a) and (d)(4)........................  Amended to state the process for approval of test methods prior to
                                               and after adoption of PBMS for all fuel programs.
80.1348.....................................  Amended to state the sample retention requirements prior to and
                                               after adoption of PBMS for all fuel programs.
80.1354(b)(2)...............................  Amended to require identification of the test method used to
                                               measure the benzene concentration of a batch.
----------------------------------------------------------------------------------------------------------------

    Consistent with EPA's performance-based measurement system (PBMS)
initiative (as discussed below), today we are proposing a PBMS for
those chemical and physical properties of motor vehicle fuels regulated
by EPA's motor vehicle fuel programs. Specifically, these are gasoline
properties at Sec.  80.46, gasoline sulfur at Sec. Sec.  80.195 and
80.1603, and diesel fuel properties at Sec.  80.2(z). This PBMS sets
forth procedures and criteria by which laboratories making measurements
to demonstrate compliance with fuels regulations may qualify
alternative analytical test methods to those required in the
regulations. It also sets minimum statistical quality control (SQC)
requirements, following standard industry practices, by which
laboratories must maintain and document the precision and accuracy of
analytical methods used in the context of these programs. EPA envisions
that the proposed PBMS would provide additional flexibility to the
regulated industry in choosing test methods and foster innovation and
improvement in the precision and accuracy of the measurement of motor
fuel properties while not making any reductions in the emission
benefits that result from motor fuel programs. It should also provide
cost savings to the regulated industry by providing rapid access to
newly-developed test methods with speed and ease of analysis. Some of
these newer methods use smaller quantities of consumables and less-
expensive instrumentation that are easier to automate, thus reducing
both operating costs and environmental impact.

a. Background
    Refiners, importers and oxygenate blenders producing RFG,
conventional gasoline and diesel fuel are required to test these fuels
to determine the levels of various specified parameters. A designated
test method is associated with each parameter to be tested (except for
sulfur concentration in ultra-low sulfur diesel fuel, which must meet
performance-based requirements \405\) in 40 CFR part 80. Table VI-5
lists the parameters/fuels and their corresponding designated test
methods that we are proposing to update.
---------------------------------------------------------------------------

    \405\ See Sec. Sec.  80.580, 80.584 and 80.585.

                   Table VI-5--Designated Analytical Test Methods for Gasoline and Diesel Fuel
----------------------------------------------------------------------------------------------------------------
               Fuel parameter                                    Designated analytical method
----------------------------------------------------------------------------------------------------------------
Sulfur in gasoline..........................  ASTM D 2622-10
Sulfur in butane............................  ASTM D 6667-10
500 ppm Sulfur Diesel Fuel..................  ASTM D 2622-10
Olefins in gasoline.........................  ASTM 1319-10
Reid vapor pressure (RVP) in gasoline.......  ASTM D 5191-10b, with the following correlation equation:
                                              RVP psi = (0.956 * X) - 0.347
                                              RVP kPa = (0.956 * X) - 2.39
                                              where:
                                              X = total measured vapor pressure in psi or kPa.
Distillation in gasoline....................  ASTM D86-11a
Benzene in gasoline.........................  ASTM D 3606-10, except that instrument parameters shall be
                                               adjusted to ensure complete resolution of benzene, ethanol, and
                                               methanol peaks.
Aromatics in gasoline.......................  ASTM D 5769-10, except that sample chilling requirements in
                                               section 8 of this standard are optional.
Oxygen and oxygenate content in gasoline....  ASTM D 5599-00(2010)
Aromatics in diesel fuel....................  ASTM D1319-10
----------------------------------------------------------------------------------------------------------------

    In addition to the designated analytic methods for the parameters
mentioned above, EPA has specified alternative test methods for some
parameters. These alternative test methods may be used in lieu of the
corresponding designated test methods, provided that all test results
are correlated to the appropriate designated test methods. Alternative
test methods have not been established for all regulated motor vehicle
fuel parameters, however. Specifically, alternative test methods have
been established for measuring the gasoline properties of aromatic
content,\406\ oxygenate content,\407\ olefin content,\408\ and sulfur
content \409\ as well as sulfur in butane.\410\ Currently, if a
regulated party wishes to use an alternative test method that is not
already approved, it must petition the Agency, and EPA must approve the
use of this alternative method through a rulemaking process that on
average, may take more than a year to complete.
---------------------------------------------------------------------------

    \406\ ASTM D 1319-03[epsiv]\1\ (see Sec.  80.46(f)(3)).
    \407\ ASTM D 4815-04 (see Sec.  80.46(g)(2)).
    \408\ ASTM D 6550-05 (see Sec.  80.46(b)(2)(i)).
    \409\ ASTM methods D 5453-08a, D 6920-07, D 3120-06[epsiv]\1\,
and D 7039-07 (see Sec. Sec.  80.46(a)(3)(i) through
80.46(a)(3)(iv)).
    \410\ ASTM D 4468-85 (reapproved 2000) and ASTM D 3246-96 (see
Sec. Sec.  80.46(a)(4)(i) and 80.46(a)(4)(ii)).
---------------------------------------------------------------------------

    Approving new methods through rulemaking has been identified as a
barrier to the use of innovative analytical test methods. In order to
address these concerns and similar ones in other media areas, the
Agency's Environmental Monitoring Management Council established a
workgroup of scientists representing EPA's Headquarters and Regional
offices to consider establishing a performance-based approach to
specifying analytical testing requirements. On the recommendations of
the workgroup, the Agency decided to incorporate the PBMS approach into
its programs, to the extent feasible.
    EPA's practice, in recent rulemaking activities, of aligning its
prescribed methods with those published by Voluntary Consensus-based
Standards Bodies (VCSBs) \411\ is almost consistent with the PBMS
policy and with the National Technology Transfer and Advancement Act
(NTTAA).\412\ For example, in the nonroad diesel rulemaking, which
controlled the sulfur content of diesel fuel,\413\ EPA required only
that laboratories demonstrate their test methods' ability to meet a set
performance criteria rather than prescribing that a single specific
method be used. Today's proposal extends the diesel sulfur
qualification approach to the chemical/physical properties measured in
other motor vehicle fuel programs, with modifications appropriate to
accommodate the differences among the fuel parameters.
---------------------------------------------------------------------------

    \411\ ASTM International (ASTM) is one such organization.
    \412\ Public Law 104-113, 104th Congress, March 7, 1996, H.R.
2196.
    \413\ 69 FR 38958, June 29, 2004. This rulemaking used standard
materials with known chemical composition to evaluate the accuracy
of candidate test methods.
---------------------------------------------------------------------------

b. Overview of Proposed Program Requirements
    In a June 29, 2004 rulemaking, EPA specified a performance-based
approach to measuring diesel sulfur at 15 ppm and 500 ppm and removed
the previous requirement of particular designated and alternative
methods for 15 ppm diesel sulfur.\414\ We decided, in that rulemaking,
to offer users two approaches to selecting test methods for diesel
sulfur at the 500 ppm level. The first of these was to use either the
designated test method or specific alternative test methods.\415\ The
second option was to meet performance based requirements similar to
those adopted for 15 ppm diesel sulfur.\416\ We are proposing today to
extend the performance-based approach to method selection and
qualification to other parameters besides diesel sulfur, with
modifications appropriate to accommodate the differences among the fuel
parameters.
---------------------------------------------------------------------------

    \414\ See Sec. Sec.  80.584 and 80.545.
    \415\ See Sec.  80.580(c)(2).
    \416\ See Sec. Sec.  80.584(a)(2), 80.584(b)(2)(i) through
80.584(b)(2)(iii), and 80.585.
---------------------------------------------------------------------------

    Specifically, we are proposing requirements that laboratories would
be required to demonstrate the

precision \417\ and accuracy \418\ of chosen fuel parameter measurement
methods. Once implemented, this proposal would: (1) Require individual
laboratories to demonstrate adequate measurement quality, (2) allow
laboratories to choose methods that meet their own needs, provided they
can meet prescribed criteria rather than specific methods,\419\ and (3)
require all laboratories making regulatory measurements to establish
and maintain a statistical quality control program. EPA intends that
the measurement system resulting from this proposal would make no
compromises on precision or accuracy relative to the system that exists
under current regulations. We intend to incorporate the standards and
practices of Voluntary Consensus Standards Body (VCSB) organizations
wherever feasible.
---------------------------------------------------------------------------

    \417\ Precision--the amount of consistency in a set of
measurements performed on the same material. ASTM repeatability and
reproducibility are examples of measures of precision. ASTM
Repeatability (``r'')--the difference between successive test
results obtained by the same operator with the same apparatus under
constant operating conditions on identical test material. ASTM
Reproducibility (``R'')--the difference between two single and
independent test results obtained by different operators working in
different laboratories on identical test material using the same
method.
    \418\ Accuracy--the closeness of a single measurement to its
true value of what is being measured.
    \419\ For some parameters the criteria will be based on the
laboratory's chosen method's ability to closely predict the
measurements made by EPA's chosen or ``designated'' method. This
approach is made necessary by the ``method-dependent'' definition of
some of the parameters to be measured.
---------------------------------------------------------------------------

    Today's PBMS approach applies to the qualification of analytical
test instrumentation and methods used to measure various
characteristics of individual fuel samples. It does not apply to
sampling methods or in-line blending methods. While in-line blending
certainly includes the use of analytical measurements, it is broader in
scope than this proposal. Including in-line blending methodologies in
this proposed rulemaking would raise issues that could not be
adequately addressed in the context of this proposed rulemaking.
Furthermore, in-line blending already has a certification process, as
specified in regulations at Sec.  80.65(f), that sets forth
qualification criteria that take into account the unique combinations
of sampling, control, and analysis that are involved with in-line
blending. However, we seek comment on potentially expanding our PBMS to
include sampling or in-line blending methods.
c. How can we establish the accuracy of the measurement system (all
qualified methods/installations) for each parameter?
    We are proposing to group the gasoline and diesel fuel parameters
that must be measured (e.g., aromatics, sulfur, etc.), into two
categories. These categories depend on whether it is feasible to
construct and use gravimetric standards \420\ for defining the
parameter and thus determining the accuracy of a measurement method.
For some parameters it is difficult or perhaps impossible to make
gravimetric standards. This is particularly true where the parameter is
actually a class of chemical compounds (themselves containing multiple
chemical compounds) that may have a very large number of members (e.g.,
aromatics in gasoline). Use of gravimetric standards for establishing
accuracy may also be hindered if many of the potential measurement
methods are sensitive to the chemical composition of the material that
the analyte is added (often called the ``matrix'') and are thus prone
to being ``confused'' into giving inaccurate answers. Where these two
problems are not present, the use of gravimetric standards is the ideal
way to establish the accuracy of the analytical test method. We will
describe these as ``absolute'' parameters. The accuracy qualification
test for a method measuring such parameters should center upon its
being able to get the ``right'' answer for one or more gravimetric
standards.
---------------------------------------------------------------------------

    \420\ Gravimetric standards are test materials made by adding a
carefully weighed (hence ``gravimetric'') quantity of the analyte of
interest to a measured quantity of another substance known not to
contain any of the analyte. The result is a solution with a very
accurately known concentration of the analyte. The accuracy of
gravimetric standard reference materials can be closely controlled
and is not dependent on an analytical test method.
---------------------------------------------------------------------------

    To establish the accuracy of methods measuring each parameter where
gravimetric standards hindered, we are proposing to retain an EPA-
prescribed reference method or ``designated method'' that would, in
effect, define the parameter as ``parameter X is, for federal
regulatory purposes, whatever method Z measures.'' Parameters that
require such treatment will be described as ``method-defined''
parameters. Establishing the accuracy of a method intended to measure
such a parameter would be accomplished by relating its measurements on
a particular set of test fuels to measurements made on the same fuels
by a laboratory operating the designated method. This approach is often
referred to as correlating the new method with the designated method.
In other words, measurements from the new method (the ``candidate'' for
qualification) would be used to predict the measurements that the
designated method would get on the same fuels (with, perhaps, some
offset or adjustment equation applied) and then these predictions would
be compared with the actual measurements made from those fuels by the
designated method. If the predictions are consistently close to the
designated method measurements and evenly distributed above and below
these reference values, then the laboratory and the method it proposes
to use would have a good case for qualification with regard to
accuracy. Such a correlative approach to qualification is dependent for
its workability upon the test fuels used to establish the correlation.
Such fuels must be sufficiently varied along all important dimensions
so that day-to-day production laboratory operations are very unlikely
to turn up some unusual fuels (or a new class of fuels produced, say,
by some new refining process) for which the correlation equation
derived earlier is not accurate and where the predictions of the
designated method's results are quite erratic and inaccurate.
    In addition to the dependence of the method-defined approach upon
the choice of fuels for establishing the correlation to the designated
method, this approach also greatly elevates the importance of the
designated method that is used. An increasingly obsolete designated
method might need to be changed for practical reasons, but adoption of
a new designated method could bring about a de facto change in the
standard for the parameter in the absence of a prescribed correction
equation designed to align the new designated method with the old.
While the gravimetric approach to measurement has its own problems, it
is free of the difficulties associated with any particular method.
    Our classification of parameters into the absolute or method-
defined categories is not entirely straightforward. Of the parameters
subject to this proposal, only those with sulfur as the analyte fall
into the absolute category. Sulfur is a single element rather than a
compound (or, worse, a class of compounds with numerous members) and
thus lends itself to the construction of gravimetric standards. The
methods that are currently used to measure sulfur in gasoline and
diesel fuel have been subject to intensive recent development work and
are largely free of matrix effects. Sulfur in butane is even more

amenable to the absolute approach, since butane is a single compound
rather than a constantly varying mixture of many compounds. We also
note, as mentioned before, that the diesel sulfur rule used the
absolute approach. For these reasons we are proposing to treat gasoline
sulfur and sulfur in butane as absolute parameters.
    Beyond these two sulfur parameters, classification becomes more
difficult. Where the analyte is a class of compounds, like aromatics,
the construction of a gravimetric standard would have to be done by use
of an agreed-upon conventional recipe that includes some group of the
compounds in the class in proportions that approximate to what is found
in the actual fuels that a method will measure. If the class has
relatively few compounds and they are all available in reasonably pure
form, then they could all be included in the standard, leaving only the
issues of their respective concentrations (likely to vary among real
fuels) and the question of ``matrix effects'' as discussed above. Where
the class of compounds has many members and not all could be included
in an artificially constructed standard, we are left with the question
of which ones can be omitted on grounds that they are likely to occur
only in very small concentrations and/or are not particularly important
in emission formation. The result of these exclusions, for certain
parameters, would likely be a directional bias toward underestimating
the prevalence of the target class of compounds. The likely size of the
bias will vary among parameters and among fuels on which measurements
are made. Use of a complex recipe for such standards, where possible,
may minimize the bias, but may add to the costs and difficulty of
formulating a standard representative of all fuels.
    The distillation parameters (T50 and T90) seem to be largely
resistant to a gravimetric approach that relies on pure compounds
instead of the smooth curve that results from simple distillation of
complex mixtures like gasoline and diesel fuel. Such gravimetric
standards, incorporating only a very limited number of compounds out of
practical necessity, would be likely to yield a kind of stair-step
curve.
    Given these logical and practical difficulties with using a
gravimetric approach to qualifying methods for parameters other than
sulfur, EPA is today proposing that the method-defined or correlative
approach be used for all parameters other than sulfur. We are
especially interested in receiving comment on our categorization of
fuel parameters as either absolute or method defined.
d. How would analytic methods be evaluated for qualification?
i. General provisions: To which methods and which parties do the
proposed requirements apply?
    As discussed above, EPA believes that the interests of measurement
quality are best served by evaluating most method installations for
qualification at the level of individual laboratories instead of
individual instruments. This approach was used in regulating diesel
sulfur. We are proposing to require laboratories to qualify all methods
that will be used to make measurements for regulatory purposes. EPA
does not believe that a relatively simple qualification test will
ensure continued measurement quality, but rather that this will greatly
reduce the likelihood of a laboratory undertaking important
measurements without some assurance that the instrument is in working
order, that at least one operator \421\ in the laboratory understands
the method for its use, and that it can be made to perform to meet
acceptable criteria. We seek comment on requiring laboratories to
qualify all methods used to take measurements for regulatory purposes.
---------------------------------------------------------------------------

    \421\ The intent behind the qualification process is to
demonstrate the facility's capability with the method. Accordingly
we are not proposing that each instrument used to implement a
particular method be required to qualify (some labs may have several
instruments implementing a single method) or that each operator be
so required. We recommend, but are not proposing to require, that a
laboratory rotate operators during the testing required for
qualification, thereby both improving and testing the skills of all
operators for a given method and strengthening its quality program.
---------------------------------------------------------------------------

ii. How would laboratories demonstrate the precision and accuracy of
methods for measuring ``absolute'' parameters and thus qualify the
methods for use?
    We are proposing to require a separate qualification for test
methods used to measure gasoline sulfur. As mentioned previously, the
Agency has successfully implemented performance based requirements for
sulfur in diesel fuel. The test methods typically used for gasoline
sulfur (one of the two parameters we are proposing to consider
absolute, as discussed above) are also frequently used for diesel
sulfur and the ASTM test method designations for both are the same.
However, examination of test method descriptions points toward
substantial differences in how the test methods are used in the
different matrices. One example is a requirement for recalibration when
matrices shift. While we considered the possibility of allowing the
diesel sulfur qualifications to be used also for gasoline sulfur, we
believe the differences between a diesel fuel matrix and gasoline fuel
matrix may be too great to permit such a sweeping exemption from
qualification requirements. The process of reworking the test methods
to measure gasoline sulfur will, in many cases, generate most of the
data needed for qualification, and thus will not represent a major
additional effort. So, despite the fact that ASTM test methods are the
same for gasoline and diesel, we are proposing to require separate
qualification for test methods used in measuring gasoline sulfur.
    Operational Description. We are proposing to require applications
for qualification to include a complete operational description of the
test method in question. A VCSB publication would satisfy this
requirement for methods published by such organizations as ASTM. The
description must include the scope of the test method, a summary,
discussion of any interferences that are expected, apparatus needed,
reagents, sampling and specimen preparation, calibration, test method
procedure, calculations, and any test method-specific quality control.
    Precision Qualification. We are proposing requirements for
precision qualification that are similar to requirements set forth in
the nonroad diesel sulfur rule. That rule imposed a maximum value for
the standard deviation \422\ of a series of at least 20 measurements
over at least 20 days on a single fuel under site precision conditions.
Specifically, the diesel rule used 1.5 times the repeatability standard
deviation (ASTM ``r''/2.77) of what was the least precise of the then-
allowed methods. The factor of 1.5, expands the allowable variability
from that of back-to-back tests (as in ASTM's definition of
repeatability) to account for the sources of greater variability that
find their way into a longer series of tests on the same material. In
the qualification process for ultra-low sulfur diesel testing, the
factor of 1.5 proved to be neither so tight that most laboratories were
unable to meet it, nor so loose as to not be challenging at all. Thus
we consider it to be reasonable on its face, as well as having proven
to be workable in practice, and we have therefore retained it in this
proposal. We request comments on the selection of a test method's
repeatability to use as the basis of the qualification.
---------------------------------------------------------------------------

    \422\ Where the standard deviation is estimated from a sample of
the population (formula uses ``N-1'' in the denominator).
---------------------------------------------------------------------------

    Gasoline Sulfur Criterion. We are proposing to use the ASTM
repeatability

standard deviation factor as discussed above from ASTM D7039-07 to set
the precision criteria for gasoline sulfur. We note that there is a
designated test method and four alternative test methods for gasoline
sulfur. The larger repeatability among the test methods currently
allowed for sulfur in gasoline is for ASTM D6920-07. This was obtained
only when the substantially more variable of the two instrument models
included in a small inter-laboratory study was included. Since the most
variable instrument model had a repeatability of nearly twice that of
the other test methods and over four times that of the other instrument
model for the same method, we believe that ASTM D6920-07 should be
represented, for this purpose, by the instrument model yielding the
better performance of the two. Given that decision, ASTM D7039-07 is
left with the largest repeatability of these test methods. And we are
proposing to use its repeatability (1.76 ppm at 10 ppm) to set the
precision criterion for this parameter. Thus the maximum allowable
standard deviation of the twenty test results on a 10 ppm gasoline
would be 0.95 ppm.\423\ Since we do not propose to prescribe the
parameter level for the fuel used for these precision tests, this
maximum limit will vary depending upon the repeatability number that
the ASTM D7039-07 test method's repeatability formula yields, given the
parameter value of the test fuel chosen. If a laboratory selected a 5
ppm fuel to test instead of a 10 ppm fuel, the maximum limit for the
standard deviation would be 0.67 ppm.
---------------------------------------------------------------------------

    \423\ This number was determined by using the repeatability
equation for ``r'' from ASTM D7039-07 for a 10 ppm sulfur gasoline
to get 1.76 ppm, dividing the ``r'' in ppm by 2.77 to obtain the
underlying standard deviation of 1.39 ppm, and multiplying the
result by 1.5 (criterion used in diesel sulfur rule) to get 0.95
ppm.
---------------------------------------------------------------------------

    Sulfur in Butane Precision Criteria. There are three test methods
currently allowed for measuring the sulfur content of butane for
blending into gasoline. A new designated test method was adopted for
this parameter (ASTM D6667-10) \424\ because the previous primary test
method, D3246-11, had become somewhat obsolete. Given that D3246-11 is
no longer widely available,\425\ though still an allowed alternative
test method, and that the range of D4468-85 (reapproved 2006) extends
only to 20 ppm, we are proposing a precision criterion based on the
repeatability of D6667-10. This test method's repeatability at the 10
ppm level is 1.15 ppm, so the calculations used above with gasoline
sulfur yield an upper limit for the standard deviation of the 20 tests
for sulfur in butane of 0.62 ppm.
---------------------------------------------------------------------------

    \424\ 71 FR 16492 (April 3, 2006).
    \425\ See EPA-HQ-OAR-2005-0048-0002.
---------------------------------------------------------------------------

    Temporal Distribution of Precision Tests. With regard to spacing of
the 20 precision tests, we are proposing 7 or fewer tests per week and
2 or fewer tests per day. We believe this would prevent weekend testing
while also precluding practices such as conducting one test on the
first day and 19 tests on the 20th day. We believe that adequate
spacing of testing is necessary if we are to have a meaningful standard
for the longer-term stability of a particular test method in a
particular laboratory installation. We are also taking comments on the
following two options: (1) a requirement that 23 or more hours must
elapse between tests (this option requires either testing on weekends
or an extension of the 20 days); and (2) tests arranged into no fewer
than five batches of five or fewer tests each, with only one such batch
allowed per day.
    Accuracy Qualification. We are proposing accuracy criteria for
absolute fuel parameters that are similar to the criteria for sulfur in
diesel fuel. Applicants for qualification would be required to select
two commercially available gravimetric standard reference materials and
then to show that their laboratory and method are capable of getting an
average of ten consecutive results that are very close to the Accepted
Reference Value or ARV for each. How close to the ARV these averages
must be is the stringency part, and we propose to use 0.75 times the
precision criterion described above, which is the same value as the
diesel rules. In the case of gasoline sulfur, for a gravimetric
standard with ARV = 10 ppm, this would be 0.75 times 0.95 ppm or 0.71
ppm. The corresponding numbers for sulfur in butane at the 10 ppm level
would be 0.75 times 1.15 or 0.47 ppm. We are proposing that for other
parameter that might come to fall into the absolute category, the
precision and accuracy criteria would be determined as a function of
the ASTM repeatability of one of the methods (selected by EPA)
available for measuring that parameter.\426\
---------------------------------------------------------------------------

    \426\ It is important to understand that the numerical examples
presented in the text are entirely hypothetical, since use of
precision testing material or gravimetric standards at levels other
than those used in the examples would change all of the numbers. Use
of a gasoline sulfur gravimetric standard at 5 ppm (instead of the
10 ppm used in the example) would require computing the
repeatability of the method at 5 ppm using the equation given in the
method description, dividing it by 2.77, multiplying the result by
1.5, and then multiplying that result by 0.75. As a short-cut, the
accuracy criterion could be determined by multiplying the ASTM
repeatability of the method at the level in question by 0.4061.
---------------------------------------------------------------------------

iii. How would laboratories demonstrate the precision and accuracy of
methods for measuring ``Method-Defined'' parameters and qualify the
methods for use?
    Operational Description. For method-defined parameters we are
proposing the same operational description as that for absolute
parameters. The operational description of a proposed test method must
be very complete. We consider publication of a test method by a VCSB
organization such as ASTM to meet this criterion. For non-VCSB test
methods this description must meet very high standards for completeness
and clarity. Since non-VCSB test methods have not been fully vetted by
a VCSB, a non-VCSB test method would require additional information. In
particular, the underlying scientific measurement principles must be
thoroughly explained and the apparatus described well enough that a
trained outsider could successfully implement the non-VCSB test method
and replicate the applicant's results.
    Precision Qualification Specifics. We are proposing the same
precision qualification criteria as absolute parameters. For those
method-defined parameters with alternative test methods that have been
identified by regulations, preference will be given to the least
precise of the allowed test methods. For reference installations we
propose the additional requirements that the instrument must be shown
to be in statistical control, as provided for in ASTM D6299-10\e1\ (and
the SQC procedures to be discussed below); and that the applicant must
submit control charts showing a record of in-control operation for at
least five months. While these requirements would likely result in a
delay between instrument setup and the ability to qualify it as a
reference installation, we believe that the delay is necessary to
demonstrate the stability of these critically important installations.
Considering the number of long-established installations of these
designated test methods, EPA expects no lack of laboratories capable of
meeting these standards and able to provide this service commercially
to any party interested in qualifying a new installation of an
alternative test method for a method-defined parameter. Table VI-6 sets
out our proposed precision criteria for the various method-defined fuel
parameters with no alternative test method.
    Olefins in Gasoline Criterion. The designated method for this
parameter, ASTM D 1319-10, is also the less

precise of the two methods currently allowed. As such, its
repeatability statistics are proposed as the basis for precision
qualification. Thus for a test fuel with olefins at, say, 9 volume
percent, the repeatability is 0.972, and the underlying standard
deviation is 0.972/2.77 = 0.351, and the precision criterion is 1.5
times that, or 0.53 volume percent. A laboratory's standard deviation
for the 20 tests could not exceed that value and still qualify for
precision.
    Aromatics in Gasoline Criterion. We are proposing to use the
repeatability standard deviation for D1319-10 to set the precision
criteria for aromatics in gasoline. (e.g., 1.3 volume percent for a
fuel with 32 volume percent aromatics). The cut off point for the 20-
test standard deviation using the test fuel would then be 0.70 volume
percent. We note that D5769-10 is the current designated test method
but that D1319-10 is still widely used. We also note that while not as
precise as D5769-10, D1319-10 is the designated method for olefins, and
has precision sufficiently close to that of the more modern designated
method to make it still viable.
    Oxygen and Oxygenates in Gasoline Criterion. The two test methods
allowed for oxygen are very close together in precision, at least for
total oxygen content. The designated method, D5599-00(2010) is slightly
less precise, leading us to propose that its repeatability be used to
determine the criterion. So for a test gasoline with 3 mass percent
total oxygen, the repeatability would be 0.083 mass percent and the
criterion for precision in this example comes out to 0.045 mass
percent.
---------------------------------------------------------------------------

    \427\ Where maximum allowable standard deviation (SD) of 20
tests is less than or equal to 1.5 times the repeatability (r) of
the designated test method divided by 2.77 (SD of 20 tests <= 1.5 X
(r/2.77)).

 Table VI-6--Method-Defined Precision Criterion for Fuel Parameters With
              No Alternatives to the Designated Test Method
------------------------------------------------------------------------
                                    Example of fuel
                                    parameter level   Proposed precision
         Fuel Parameter            for demonstrating    criterion \427\
                                       precision
------------------------------------------------------------------------
RVP in gasoline.................  RVP sample of       0.11 psi.
                                   gasoline equals
                                   6.8 psi.
Distillation in gasoline........  Gasoline sample     IBP = 1.54 [deg]C.
                                   with initial       E10 = 0.72 [deg]C.
                                   boiling point      E50 = 0.40 [deg]C.
                                   (IBP) of 20        E90 = 0.97 [deg]C.
                                   [deg]C and 90      FBP = 1.80 [deg]C.
                                   percent
                                   evaporated (E90)
                                   temperature of
                                   110 [deg]C.
Benzene in gasoline.............  Gasoline sample     0.02 volume
                                   containing 1        percent benzene.
                                   volume percent
                                   benzene.
Aromatics in diesel fuel........  Diesel sample       0.70 volume
                                   containing 35       percent.
                                   volume percent
                                   aromatics.
------------------------------------------------------------------------

    Accuracy Qualification. Test methods used to measure method-defined
parameters can be grouped into three types: reference installations of
designated methods intended for use in qualifying alternative methods;
designated method installations intended for ordinary production
measurements; and non-designated methods. Since these reference
installations will be used to evaluate the accuracy of other test
methods and to evaluate whether the need for the establishment of a
correlation equation. We are proposing that such reference instruments
must be shown to be near the middle of the distribution of the industry
monthly inter-laboratory crosscheck program for at least five months
prior to application.\428\ We are proposing that laboratories would
specifically compute the difference between either the instrument's
average measurement of the fuel closest to the applicable standards or
to the average value for the fuel type in the complex model and the
robust mean for that fuel obtained by all of the non-outlier labs in
the program. We are proposing that the differences would then be
standardized by expressing it in robust standard deviation units. This
standardized inter-laboratory cross check (ILCC) differences would be
put into a moving average with a span of, for example, five months. We
are also proposing to set the standard such that the instrument's
moving average would be within the central 50 percent of the
distribution of participating designated method labs. Because a robust
standard deviation is used by the ILCC program, this percentage will
have to be approximate. Such lab-specific qualification would be
outside of the normal qualification of a lab for making regulatory
measurements for certifying fuel and would pertain only to use of the
instrument in certifying other methods. EPA requests comment on the
nature and stringency of this proposed requirement. Specifically, we
request comment as to whether this is a reasonable requirement that is
likely to be met by instruments in the best qualified laboratories.
Could the ``middle 50 percent'' requirement be further tightened
without severely restricting the supply of potential reference
installations? Are there computationally simpler ways to accomplish the
general purpose of this requirement?
---------------------------------------------------------------------------

    \428\ An alternative to this measure can be to use the D6299-
10\e1\ calculations. This would require statistical quality control
(SQC) so that the instrument would have an acceptable quality of
performance. This could reduce the burden of calculations and align
this requirement better with the NTTAA.
---------------------------------------------------------------------------

(1) Role of Voluntary Consensus Bodies in Qualifying Alternative
Analytical Test Methods
    In February 1996, Section 12(d) of Public Law 104-113, Congress
passed the National Technology Transfer and Advancement Act of 1995''
(NTTAA), in order to establish the policies of the existing OMB
Circular A-119 in law.\429\ The purposes of Section 12(d) of Public Law
104-113 are: (1) To direct ``federal agencies to focus upon increasing
their use of [voluntary consensus] standards \430\ whenever possible,''
thus reducing federal procurement and operating costs; and (2) to
authorize the National Institute of Standards and Technology (NIST) as
the ``federal coordinator for government entities responsible for the
development of technical standards and conformity assessment
activities,'' thus eliminating ``unnecessary duplication of conformity

assessment activities.'' \431\ Section 21(d) of Public Law 104-113 also
gives agencies the discretion to use other standards in lieu of
voluntary consensus standards where use of the latter would be
``inconsistent with applicable law or otherwise impractical.'' However,
in such cases, the head of an agency or department must send to OMB,
through NIST, ``an explanation of the reasons for using such
standards.''
---------------------------------------------------------------------------

    \429\ See 142 Cong. Rec. H1264-1267 (daily ed. February 27,
1996) (statement Rep. Morella); 142 Cong. Rec. S1078-1082 (daily ed.
February 7, 1996) (statement Cong. Rockefeller); 141 Cong. Rec.
H14333-34 (daily ed. December 12, 1995) (statements of Reps. Brown
and Morella).
    \430\ This use of the word ``standards'' refers to test methods,
calibration materials, etc.
    \431\ See Cong. Rec. H1262 (daily ed. February 27, 1996)
(statements of Rep. Morella).
---------------------------------------------------------------------------

    The final revision of Circular A-119 defines Voluntary Consensus
Standards as ``standards developed or adopted by voluntary consensus
bodies, both domestic and international'', and defines VCSB as
``domestic or international organizations which plan, develop,
establish, or coordinate voluntary consensus standards using agreed-
upon procedures and which possess the attributes of openness, balance
of interest, due process, an appeals process, and consensus.'' Finally,
Circular A-119 indicates that consensus means ``general agreement, but
not necessarily unanimity, and includes a process for attempting to
resolve objections by interested parties, as long as all comments have
been fairly considered, each objector is advised of the disposition of
his or her objection(s) and the reasons why, and the consensus body
members are given an opportunity to change their votes after reviewing
the comments.'' \432\
---------------------------------------------------------------------------

    \432\ 63 FR 8546 (February 19, 1998).
---------------------------------------------------------------------------

    The Agency believes that VCSBs can play a valuable role in
developing statistical tools for analytical test methodology
description and evaluation, developing and describing new analytical
test methodologies and organizing test programs to evaluate
methodologies and assist laboratories to maintain quality measurement
systems.
    EPA has frequently selected VCSB-developed methods as its
designated methods for fuels programs. However, it has only adopted a
particular version of each such method by incorporating it by reference
in the Federal Register. In each case the Agency was endorsing and
adopting test methods that were completely known and available for
examination, rather than the unknown result of some future VCSB action.
To simply say that any method approved by a VCSB is acceptable for all
purposes, including compliance demonstrations would seem to invite such
difficulties as: (1) multiple methods for a parameter, developed by
different VCSB's and not correlated adequately with each other, or (2)
methods that change over time (by publication of new versions, for
example) in such a way that the definition of what is being measured
changes and no longer corresponds to what was used in setting
compliance to the environmental standard(s).
(2) Use of Reference Materials in Qualifying and Maintaining
Alternative Analytical Techniques
    Depending on the qualification process chosen by the Agency,
discussed in more detail below, the protocol proposed here for the
qualification and maintenance of alternative test methods stops short
of automatic acceptance of VCSB decisions and methods, but goes as far
in that direction as we believe is consistent with the Agency's mission
of ensuring compliance with motor vehicle fuel programs. It gives some
preference to VCSB-approved methods because of our greater confidence
that such methods have been positively evaluated by a broad user
community rather than by a narrower array of users. We are proposing
today to also make substantial use of VCSB-developed statistical
protocols for comparing methods and for use by particular laboratories
in keeping analytic methods under adequate statistical quality control.
    We consider Reference materials to be samples of the type of
material to be tested (gasoline or diesel fuel in this case) that are
known or thought to have a particular concentration of the substance to
be measured. Laboratories may use these materials to calibrate and
evaluate the performance of measurement systems. EPA is proposing the
following three types of reference materials that would be used in
establishing and maintaining the accuracy of both designated and
alternative analytical test methods: (1) Gravimetric standards, (2)
consensus-named fuels (gasoline or diesel fuel), and (3) locally-named
standards.
    Additionally, some combinations of parameters and test methods
limit the availability of some kinds of reference materials. This
complicates the task of developing a methodology for qualifying
alternative test methods. EPA recognizes the technical complexity and
the likelihood that new analytical testing methods may emerge.
Therefore, the Agency is also proposing to offer substantial
flexibility in the choice of standard reference materials and the
manner of their use, so long as they ensure accuracy and preserve the
integrity of applicable fuel standards.
    Gravimetric Reference Standards. Gravimetric standards are test
materials made by adding a carefully measured quantity of the analyte
of interest to a measured quantity of another substance known not to
contain any of the analyte. The result is a solution with a very
accurately known concentration of the analyte. The accuracy of
gravimetric standard reference materials can be closely controlled and
is not dependent on an analytical test method. They do present certain
practical problems in use. First, gravimetric reference materials
cannot be made for all of the parameters under the RFG, CG and diesel
fuel programs (e.g., distillation points and olefins). Second, there
are ``matrix effects.'' As earlier explained, matrix effects are where
components in real-world gasoline or diesel fuel other than the analyte
of interest confuse the instrument and cause it to measure the analyte
differently than it would when measuring the same concentration of the
analyte in a gravimetric standard built in a matrix where the
instrument is not sensitive. Matrix effects are problematic for certain
analytical methods, whose underlying scientific operating principles
make the analytical method unable to utilize gravimetric standards for
calibration when other types of materials (gasoline or diesel fuel)
will have to be measured accurately. The approach taken in this
proposal, where the gravimetric standard reference materials would be
used in establishing the accuracy of a reference implementation of the
designated method, is an approach that should minimize matrix effect
problems. This is because the designated methods were selected, among
other criteria, for their relative freedom from matrix effects. Thus,
EPA believes that such materials, offer the best tools for establishing
the accuracy of analytical test methods. When feasible, EPA believes
that gravimetric reference standard materials should form the basis for
establishing accuracy through correlation with designated analytical
test methods calibrated with gravimetric standards.
    Consensus-named Fuels. These are homogeneous quantities of fuel
that have been analyzed by a number of different laboratories (by
sending around small samples). The average concentration of some
parameter of interest across all of the different laboratories is then
used as the ``consensus name'' for that material.
    There are certain parameters that the Agency does not believe that
gravimetric standard reference materials can be prepared. Aromatics are
a class of numerous compounds that are produced by refinery processes
in a mixture that is most likely impossible to duplicate in the
laboratory with any consistency for all fuel because not all

refiners have the same configuration. For such parameters, it is
therefore necessary to use consensus-named gasolines to control
accuracy because they are the only reliable type of standard reference
material that is available. The use of consensus-named gasolines may
minimize matrix-related effects where they are used to establish the
accuracy of different designated method implementations, though they
may be less useful in evaluating alternative methods that have been
adapted to measure a certain fuel matrix, but not sensitive enough to
measure all fuel matrices the test method may encounter in use,
otherwise known as ``adaptive learning'' technologies. The nominal
concentrations in consensus-named gasolines can only be as accurate as
the designated analytical test method used in the VCSB round robin
study that named them. Consensus-named gasolines will also be costly
and time-consuming to produce and will need to be periodically replaced
(i.e., when the supply is exhausted or the shelf life expires) through
either a new round robin study or some approach using overlapped
testing of the old standard reference material with a new batch (which
will not, of course, have exactly the same concentration of analytes).
    Locally Named Reference Materials. These materials are also
sometimes referred to as quality control samples (e.g., octane testing
reference fuel). These are gasoline or diesel fuels that usually come
from the regular production of the facility. These reference materials
are used in laboratory quality control efforts and have been analyzed
using the designated method (either by the facility's lab or by a
referee lab) to obtain an estimate of their concentration. The fuels
are then stored carefully by the lab to slow their deterioration. The
advantage to these is that since a refinery may already have such fuels
on site for octane or cetane testing purposes, these materials may be
relatively inexpensive. Another advantage is that, since a refiner
would produce these fuels at the same site where the alternative method
will be qualified, their use should minimize any difficulties
associated with matrix effects. These locally named reference fuels are
not as accurate as the VCSB round robin process and are not assured by
gravimetric standard reference material construction. Thus, a refiner
could only use them for relating an alternative method to a carefully
calibrated installation of the designated method whose accuracy has
been established and controlled by other means.
    We request comment on the appropriateness of using the three types
of standard reference materials for accuracy that have been discussed
and on their applicability in the qualification process and statistical
quality control process of analytical test methods.
(3) Qualification Criteria of Alternative Analytical Test Methods
    We are also proposing two options for refiners that wish to qualify
an alternative test method as discussed in further detail in Sections
VI.A.3.g.i and VI.A.3.g.ii of this proposal. For both of the proposed
options the candidate test method must have precision at least equal to
that of the designated analytical test method (though not defined in
precisely the same way). And the alternative test method must be
capable of correlation with the designated test method for the
parameter such that the refiner may use the alternative test method
results to produce predicted designated test method results that it can
subsequently use in demonstrating compliance with the applicable fuel
composition or performance standards.
(4) Statistical Quality Control Program
    An important element of today's proposed approach for the
qualification of alternative analytical test methods is the description
of a statistical quality control (SQC) program that may be applied to
any analytical test method used in the regulatory programs covered by
this proposal. We are proposing to require a SQC program as described
below. EPA's objective with statistical quality control is not to
impose a complete new system of quality control measures, but rather to
adopt a subset of SQC procedures that are already widely in use. We
anticipate that the measures we have selected would not require the
generation of much additional data by the laboratories that elect to
employ them and that the SQC program would improve the quality of
measurement among those labs that adopt such measures.
e. Qualification Criteria for Designated Method Installations Used To
Qualify Method-Defined Parameter Instruments
    Designated test method installations that will be used to qualify
method-defined parameter instruments are reference installations. Since
reference installations will be used to evaluate the accuracy of other
alternative test methods and to establish correlation equations, EPA
believes that these reference installations should be held to higher
standards.
    First, we are proposing that reference instruments meet precision
qualification requirements that are similar to the criteria set forth
in the nonroad diesel sulfur rule. As explained earlier, that rule
imposed a maximum value for the standard deviation \433\ of a series of
at least 20 measurements over at least 20 days on a single fuel under
site precision conditions. Specifically, the diesel rule used 1.5 times
the repeatability standard deviation (ASTM ``r''/2.77) of what was the
least precise of the then-allowed methods. For those ``method-defined''
parameters from Table VI-1 above that do not currently have
alternatives test methods the precision criteria is based on the fuel
parameter's designated test method. In each case the precision
criterion is determined by (``r''/2.77) X 1.5 where ``r'' is the ASTM
repeatability determined for the particular fuel that is being used for
the purpose of demonstrating the test method's precision.
---------------------------------------------------------------------------

    \433\ Where the standard deviation is estimated from a sample of
the population (formula uses ``N-1'' in the denominator).
---------------------------------------------------------------------------

    Second, we are proposing that such reference instruments must be
shown to be near the middle of the distribution of the industry monthly
inter-laboratory crosscheck (ILCC) program for at least the five months
prior to application.\434\ We are also proposing that laboratories
would specifically compute the difference between the instrument's
average measurement of the fuel closest to the applicable standards (or
to the average value for the fuel type in the complex model) and the
robust mean for that fuel obtained by all of the non-outlier labs in
the program. And then standardize this difference by expressing it in
robust standard deviation units. These standardized inter-laboratory
cross check differences would be put into a moving average with a span
of, for example, five months. We are proposing to set the standard such
that the instrument's moving average would be within the central 50
percent of the distribution of participating designated method labs.
Because a robust standard deviation is used by the ILCC program, this
percentage will have to be approximate. Such lab-specific qualification
would be outside of the normal qualification of a lab for making
regulatory measurements

for certifying fuel and would pertain only to use of the instrument in
certifying other methods. In essence, these designated method
installations will serve as surrogates for the gravimetric standards
that cannot be used in qualifying alternative methods for method-
defined parameters.
---------------------------------------------------------------------------

    \434\ An alternative to this measure can be to use the ASTM
D6299-10\e1\ calculations. This would require SQC so that the
instrument would have an acceptable quality of performance. This
could reduce the burden of calculations and align this requirement
better with the NTTAA.
---------------------------------------------------------------------------

    Finally, for reference installations we propose that the reference
instrument must be shown to be in statistical control, as provided for
in ASTM D6299-10\e1\ (and the SQC procedures to be discussed below);
and that the applicant must maintain control charts showing a record of
in-control operation for at least five months. While these requirements
would likely impose a delay between instrument setup and the ability to
qualify it as a reference installation, we believe that the delay is
necessary to demonstrate the stability of these critically important
installations. Considering the number of long-established installations
of these designated methods, EPA expects no lack of facilities capable
of meeting these standards and able to provide this service
commercially to any party interested in qualifying a new installation
for a method-defined parameter.
f. Qualification Criteria for Designated Test Method Installations That
Are ``Method-Defined'' Parameters Instruments and Not Used To Qualify
Other ``Method-Defined'' Methods
    Refiners, importers and oxygenate blenders producing gasoline and
diesel fuel are required to test these fuels to determine the levels of
various specified parameters. A designated test method is associated
with each parameter to be tested (except for sulfur concentration in
ultra-low sulfur diesel fuel, which must meet performance-based
requirements\435\) in 40 CFR Part 80. Table VI-5 of this preamble lists
the fuel parameters and their corresponding designated test methods.
---------------------------------------------------------------------------

    \435\ See Sec. Sec.  80.580, 80.584 and 80.585.
---------------------------------------------------------------------------

    We are proposing today that installations of designated methods
must maintain records they meet statistical quality control
requirements as detailed below in this preamble. Requiring all
installations of all methods, including existing designated method
installations, to implement statistical quality control, as we are
proposing today, would likely suffice to homogenize and improve
measurement quality in these already-stable and standardized methods.
g. Qualification Criteria for Method Defined Parameter Instruments
Other Than Designated Test Methods
    As discussed above, the Agency is also proposing to have two
options for refiners to qualify an alternative test method that is a
method-defined fuel parameter. The first option would allow for
qualifying methods that have been sponsored and published by a VCSB,
such as ASTM (the VCSB approach). The second way involves qualification
for a laboratory that has developed its own analytical test method but
has decided not to offer it for evaluation and establishment through a
VCSB-based organizational process (the non-VCSB approach). Both options
require the candidate method to have precision at least equal to that
of the designated analytical test method (though not defined in
precisely the same way). The alternative method must also be capable of
close correlation with the designated method for the parameter such
that the refiner may use the alternative method results to produce
predicted designated method results that it can subsequently use in
demonstrating compliance with the applicable fuel composition or
performance standards. The proposed criteria for both the VCSB and non-
VCSB approaches to qualify method-defined instruments are discussed in
further detail below.
i. Qualification Criteria for VCSB Method-Defined Parameter Test
Methods
    The first of these approaches to qualifying alternative methods
applies only to methods that have been sponsored and published by a
VCSB, such as ASTM. We are proposing that the VCSB must have fully
described the analytical test method, so that it is replicable in
different laboratories and understood by any technician. We would
consider publication of a method by a VCSB organization such as ASTM to
meet this criterion. The VCSB must have tested the candidate method in
a round robin program against the designated method, must have
published a determination that the method meets the criteria specified
in the discussion below, and must have published the information
necessary to correlate the alternative method to the designated
method.\436\
---------------------------------------------------------------------------

    \436\ This first approach assumes that a single such equation
can be used for all labs using the method, an assumption that may
not always hold. The more detailed discussion of the two approaches
that follows this introduction explores this problem.
---------------------------------------------------------------------------

    We are also proposing that an alternative analytical test method
need not be qualified separately in each laboratory that adopts it.
This is because by the time such a test method has been through the
extensive development process typically required by a VCSB, the
method's procedures would have been exhaustively described. At this
point there will be little uncertainty about how the analytical test
method is to be applied, and it will have been implemented in a variety
of different laboratories and used on a variety of different types of
fuels. Therefore the VCSB-based process gives EPA some confidence that
the analytical test method is likely to be stable in use and can be
implemented with very little ambiguity regarding instrumentation,
materials, and procedures. Moreover, VCSB method evaluation protocols
have been established; including a protocol for comparing methods
provide means for establishing a proposed VCSB alternative method's
precision parity with the designated method for the parameter and for
determining whether the alternative method can be adequately correlated
with the designated method.\437\ EPA is also proposing that VCSB
method-defined test methods utilize ASTM D6708 to determine if a
correlation equation is necessary.
---------------------------------------------------------------------------

    \437\ ASTM D 6708-08, entitled, Standard Practice for
Statistical Assessment and Improvement of Expected Agreement Between
Two Test Methods that Purport to Measure the Same Property of a
Material.
---------------------------------------------------------------------------

ii. Qualification Criteria for Non-VCSB Method-Defined Parameter Test
Methods
    The second way a candidate alternative method may qualify does not
involve the process by which a VCSB evaluates and officially establish
methods through publication. EPA is proposing that a candidate method
that follows the non-VCSB-based route for qualification must be
qualified independently by each analytical laboratory that wishes to
adopt the method. This is because such a method has not been shown to
be capable of accurately measuring the parameter in different
laboratories and across a variety of fuel matrices.
    The following is a discussion of the qualification criteria for
non-VCSB method-defined parameter test methods. First, the Agency
proposes to require a complete operational description of the non-VCSB
test method, as described above in Section VI.A.3.d.ii and VI.A.3.d.iii
of this preamble. The operational description must be thorough enough
that a person lacking expertise in the operation of the test instrument
would be able to replicate its results.

    Second, the Agency proposes that the candidate non-VCSB test method
be tested on a range of fuels \438\ and by a qualified reference
installation of the applicable designated test method.
---------------------------------------------------------------------------

    \438\ Fuels, either consensus named fuels or locally named
reference materials, used must be typical of those to be analyzed by
the facility in practice and must meet the data requirements
(variability, etc.) of ASTM D6708-08.
---------------------------------------------------------------------------

    Third, the Agency proposes that the specific laboratory using the
candidate non-VCSB test method must statistically establish through
application of ASTM D6708-08 that the candidate method measures the
same aspect of samples as the applicable designated test method.
    Fourth, the Agency is proposing to disqualify non-VCSB test methods
with important sample-specific biases (matrix effects) that cannot be
considered as random as determined by ASTM D6708-08. It is possible a
situation may arise where a non-VCSB test method suspected by the
applicant of being highly matrix-sensitive may be qualified on a
narrowly circumscribed range of fuels (which must meet the D6708-08
statistical variability criteria). In this situation, the types of
fuels on which qualification was achieved and for which the method is
to be approved must be specified in the method description. Fuels
outside of this scope would have to be analyzed for regulatory purposes
by some other method that was not this limited. The Agency believes
that any restriction on the scope of fuels for which the method is to
be qualified must be accompanied by a discussion of how the applicant
plans to screen samples for conformity to the scope.
    Fifth, the Agency proposes that precision qualification be
conducted in the form of cross-method reproducibility \439\ of the
candidate and applicable designated test method, where the cross-method
reproducibility must be equal to or less than 70 percent of the
published reproducibility of the applicable designated test method.
---------------------------------------------------------------------------

    \439\ Cross-method reproducibility is a quantitative expression
of the random error associated with the difference between two
results obtained by different operators using different apparatus
and applying the two methods X and Y, respectively, each obtaining a
single result on a identical test sample, when the methods have been
assessed and an appropriate bias-correction has been applied. It is
defined as the 95 percent confidence limit for the difference
between two such single and independent results.
---------------------------------------------------------------------------

    The Agency believes, that when ASTM D6708-08 is used in this manner
(without joint round robin data) the cross-method reproducibility (Rcm)
output by the program is not really a reproducibility in the usual
sense, but rather indicates the expected value with uncertainty of the
differences between the designated method and qualification candidate
method. We believe that when used this way, Rcm from ASTM D6708-08 is
more analogous to a site precision than to an inter-laboratory
reproducibility.
    As described, this measure can reasonably be expected to fall
between the published reproducibility (R) and repeatability (r) of the
designated test method. Because qualified alternative test methods
should be able to generally do as well as the designated test method
Rcm be less than or equal to ``R''. Since ``R'' is typically
established when the test method is first developed, and laboratory
experience with it is limited, the real reproducibility for a method
long in service is likely to be smaller than ``R.'' Moreover, as
mentioned above, Rcm is more like a site precision number, for a well-
run installation, that must be smaller than ``R'' since the systematic
component of the differences between the instruments has been adjusted
out and the ``within-method-interlaboratory'' component of variance is
not present. On the other end of the space between ``r'' and ``R,'' the
published repeatability has far fewer sources of variability than any
other measure of its kind, suggesting that the cut-point should be
closer to ``R'' than to ``r''. The proposed 70 percent fraction of
published reproducibility was selected because there is some evidence
to suggest that site precisions for various methods/parameters tend to
average around that fraction of the same method's published
reproducibility. We are also requesting comment on the appropriate
percentage of ``R'' that the ``cross-method reproducibility'' should be
equal to or less than.
    Sixth, the Agency proposes that the applicant demonstrate, through
the use of ASTM D6708-08, whether a correlation to the designated test
method is necessary. ASTM D6708-08 can also be used to determine
whether the candidate method's results are null compared to the
designated test method and thus needs no adjustment or correlation, or
whether some correction or correlation equation is required so the
candidate method may predict designated method results. We are
proposing the use of ASTM 6708-08 for corrections, if it is determined
through the use of ASTM D6708-08 that the candidate method requires
such a correction to predict designated test method results. The Agency
proposes that the correction would be applied to the candidate
instruments output to obtain measurements results for regulatory
purposes.
    Finally, we are proposing to require that applicants for non-VCSB
test methods secure an independent third party oversight and audit
review of the data generated and used to qualify non-VCSB test methods.
We are proposing that the independent third party would provide an
overall assessment of the analytical technique and methodology and
discuss any limitations in the scope of the method, as well as attest
that all the requirements for non-VCSB test method qualification have
been satisfied. The Agency believes this requirement would provide
additional assurance that a non-VCSB test method is found to be
adequate in use for compliance.
    We seek comments on all aspects of today's proposal. Additionally,
the Agency is particularly interested in comments on the
appropriateness of the qualification criteria for candidate method-
defined parameter non-VCSB test methods.
h. Statistical quality control: How can we ensure that test methods
continue to deliver quality measurement in practice?
    As discussed previously, an important element of today's proposal
is a statistical quality control program that may be applied to any
analytical test method used in the regulatory programs covered by this
proposal. Today, the Agency is proposing that every laboratory using
test instruments to measure fuel parameters must implement and maintain
a basic SQC program in order to satisfy EPA's reporting or
recordkeeping requirements. We are proposing that every laboratory have
a separate SQC program for each instrument used to make measurements
for reporting or recordkeeping purposes.\440\ This is unlike the
qualification criteria requirements, where only one of a set of
essentially identical instruments implementing the same method in a
laboratory must qualify.
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    \440\ Such SQC programs are already an established part of VCSB
protocols for analytical laboratory operation (as indicated by such
practices as ASTM's D6299-10\e1\) and are likely to be part of most
laboratories ''standard operating procedures.'' Thus, such a
requirement very likely adds little or nothing in the way of burden
for most laboratories. Laboratories that lack such programs and
would have to expend significant effort to create them are those
most at risk for poor measurements and for which the effort is most
easily justified.
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    We are proposing that implementation of a SQC program by a
laboratory would be a defense in any subsequent enforcement actions
where the measurements are in use. We are proposing to adopt a subset
of SQC procedures that are already widely in use from ASTM D6299-
10\e1\. We anticipate that the measures we are

proposing would not require the generation of much additional data by
the laboratory that employs them and that the SQC program would improve
the quality of measurement among those labs that adopt such measures.
These SQC procedures used by laboratories would ensure that the test
methods they have qualified and the instruments on which the methods
are run are yielding results with appropriate accuracy and precision,
e.g., that the results from a particular instrument does not ``drift''
over time to yield unacceptable values. The proposed minimum specific
SQC requirements for laboratories that measures absolute parameters,
and both VCSB and non-VCSB methods used to measure method-defined
parameters, are discussed in further detail below.
i. Statistical Quality Control for Absolute Parameters
    We are proposing precision and accuracy SQC requirements for each
instrument used to measure absolute parameters in the laboratory. We
are proposing that every instrument would test a quality control
(``QC'') material \441\ either of: once per 20 production tests or once
per week and maintain both an ``I'' chart \442\ and an ``MR''
chart.\443\ We are proposing that any violations of the control
limit(s) would be investigated by laboratory personnel, corrective
action taken as required, and records kept of the incident for a period
of 5 years. We are also proposing to follow the procedures of ASTM
D6299-10\e1\ for making transition from one batch of QC material to
another. We are a also proposing the use of Annex A1.9, entitled ``Q-
Procedure,'' of ASTM D6299-10\e1\ for validating new QC material. We
are proposing that when QC material is soon-to-be-depleted, that a new
batch of QC material is prepared and its value compared to the old QC
material on a chart. The new batch of QC material would be tested
concurrently with the soon-to-be-depleted old QC material. The results
would be plotted from the ``old'' and ``new'' QC materials on its
respective chart, and if no special-cause signals are noted, then the
result for the new material would be considered valid.\444\
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    \441\ See ASTM D6299-10\e1\, paragraph 3.2.3 for a definition
and Section 6 for guidance, selection, construction, handling,
storage and use of reference material samples.
    \442\ See ASTM D6299-10\e1\, section 7 and Section A1.5.1 for
chart construction and usage, including criteria for deciding upon
corrective action.
    \443\ See ASTM D6299-10\e1\, Section A1.5.2 for chart
construction and usage. Any exceedance of the control limit should
be investigated.
    \444\ See ASTM D6299-10\e1\, Annex A1.9 Q-Procedure. Procedures
differ depending whether an I-chart, MR chart, EWMA chart, Q-chart
or a combination of these charts are utilized by the laboratory.
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    We are proposing to require that every instrument tests a
commercially available gravimetric standard reference material (SRM)
(``check standard'' as defined in ASTM D6299-10\e1\) on a quarterly
basis. The absolute difference between the mean of multiple back-to-
back tests of the SRM and ARV of the SRM greater than 0.75 times the
published reproducibility of the test method must be investigated by
laboratory personnel, appropriate action taken, and records kept of the
incident and investigation. We are proposing that records of the SRM
measurements and investigations into any exceedances of these proposed
criteria must be kept for a period of 5 years. Additionally, we are
proposing to require laboratories to pre-treat and assess results from
the check standard testing after at least 15 testing occasions,\445\
construct ``MR'' and ``I'' charts \446\ with control lines, and
maintain control charts, logging, investigating, and correcting the
underlying causes of any control limit violations as discussed in ASTM
D6299-10\e1\. We are proposing that records of such incidents and the
underlying control charts must be kept by the facility for a period of
5 years.
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    \445\ See ASTM D6299-10\e1\, Section 8.2 (pretreatment) and
Section 8.4 (assessment). Procedures differ depending upon whether a
single check standard is used for multiple testing occasions or
multiple check standards must be used.
    \446\ See ASTM D6299-10\e1\, Section 8.4 and appropriate Annex
sections for chart construction and guidance.
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ii. Statistical Quality Control for VCSB-Approved Methods Used To
Measure Method-Defined Parameters
    We are proposing precision and accuracy SQC requirements for every
instrument used in VCSB-approved methods to measure method-defined
parameters in the laboratory. With regard to precision, we are
proposing the same SQC for instruments used for absolute parameters. We
are proposing that every instrument test a quality control QC material
\447\ once every 20 production tests or once per week whichever is more
frequent. We are also proposing the maintenance of an ``I'' chart \448\
and a ``MR'' chart.\449\ We are proposing that violations of the
control limit(s) in these charts would be investigated, corrective
action taken as required, and records kept of the incident for a period
of 5 years. We are also proposing that laboratories follow the
procedures of ASTM D6299-10\e1\ for making the transition from one
batch of QC material to the next.
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    \447\ See ASTM D6299-10\e1\, paragraph 3.2.3 for a definition
and Section 6 for guidance, selection, construction, handling,
storage and use of reference material samples.
    \448\ See ASTM D6299-10\e1\, section 7 and Section A1.5.1 for
chart construction and usage, including criteria for deciding upon
corrective action.
    \449\ See ASTM D6299-10\e1\, Section A1.5.2 for chart
construction and usage. Any exceedance of the control limit should
be investigated.
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    With regard to accuracy we are proposing that each laboratory
perform a check standard \450\ for each instrument as defined in ASTM
D6299-10\e1\ for each instrument on a quarterly basis. We propose that
check standards for ``method-defined'' parameters must be ordinary
fuels with levels of the parameter of interest close to either
regulatory standards or to the average level of use. We also propose
that ARVs of such standards must be determined through consensus
methods \451\ on designated method instruments. The absolute difference
between the mean of multiple back-to-back tests of the SRM and ARV of
the SRM greater than 0.75 times the published reproducibility of the
test method must be investigated, appropriate action taken by
laboratory personnel, and records kept of the incident and
investigation. We are proposing that records of the SRM measurements
and investigations into any exceedance of the criteria must be kept for
a period of 5 years. Additionally, we are proposing that laboratories
must pre-treat and assess results from the check standard testing after
at least 15 testing occasions,\452\ construct ``MR'' and ``I'' charts
\453\ with control lines, and maintain control charts, logging,
investigating, and correcting the underlying causes of any control
limit violations as discussed in ASTM D6299-10\e1\. We are proposing
that records of such incidents and the underlying control charts must
be kept by the laboratory for a period of 5 years.
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    \450\ As defined in ASTM D6299-10\e1\, Section 3,2,3, and
further discussed in Section 6.2. Optimum use of materials that are
consensus-named by a number of laboratories may be possible only if
these materials are distributed in sufficient quantity that they may
be used as check standards after their consensus-determined ARV is
known by all laboratories. As mentioned in the text, only
measurements made on the designated method for the parameter in
question may be used in determining the ARV for this purpose.
    \451\ Following the guidelines of ASTM D6299-10\e1\, Section
6.2.2.
    \452\ See ASTM D6299-10\e1\, Section 8.2 (pretreatment) and
Section 8.4 (assessment). Procedures differ depending upon whether a
single check standard is used for multiple testing occasions or
multiple check standards must be used.
    \453\ See ASTM D6299-10\e1\, Section 8.4 and appropriate Annex
sections for chart construction and guidance.

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iii. Statistical Quality Control for Non-VCSB Methods Used To Measure
Method-Defined Parameters
    We are also proposing precision and accuracy SQC requirements for
instruments used in non-VCSB methods to measure method-defined
parameters in the laboratory. We are proposing precision requirements
for instruments used in these types of test methods that are the same
as those proposed for absolute parameters. We are proposing that every
instrument be tested on a quality control ``QC'' material \454\ once
per 20 production tests or once per week, whichever is more frequent.
We are also proposing the maintenance of an ``I'' chart \455\ and a
``MR'' chart.\456\ We are proposing that violations of the control
limit(s) in these charts should be investigated, corrective action