AMERICAN SOCIETY FOR TESTING AND MATERIALS et al v. PUBLIC.RESOURCE.ORG, INC.
Filing
213
RESPONSE re 202 MOTION for Summary Judgment filed by AMERICAN SOCIETY FOR TESTING AND MATERIALS, AMERICAN SOCIETY OF HEATING, REFRIGERATING, AND AIR-CONDITIONING ENGINEERS, INC., NATIONAL FIRE PROTECTION ASSOCIATION, INC.. (Attachments: # 1 Plaintiffs' Third Supplemental Statement of Material Facts, # 2 Declaration of Thomas O'Brien, # 3 Declaration of Jane W. Wise, # 4 Exhibit 174, # 5 Exhibit 175, # 6 Exhibit 176, # 7 Exhibit 177 (Part 1), # 8 Exhibit 177 (Part 2), # 9 Exhibit 177 (Part 3), # 10 Exhibit 178, # 11 Exhibit 179, # 12 Exhibit 180, # 13 Exhibit 181, # 14 Exhibit 182, # 15 Exhibit 183, # 16 Exhibit 184, # 17 Exhibit 185, # 18 Exhibit 186, # 19 Plaintiffs' Response to Defendant's Statement of Disputed Facts (Redacted), # 20 Plaintiffs' Statement of Disputed Facts and Objections, # 21 Plaintiffs' Response to Defendant's Evidentiary Objections, # 22 Plaintiffs' Opposition to Defendant's Request for Judicial Notice)(Fee, J.)
Exhibit 185
§ 80.47
Sulfur in Light Hydrocarbons, Spark
Ignition Engine Fuel, Diesel Engine
Fuel, and Engine Oil by Ultraviolet
Fluorescence, approved November 1,
2012 ("ASTM D5453").
(xi) ASTM
D5599-00 (Reapproved
2010), Standard Test Method for Determination of Oxygenates in Gasoline by
Gas Chromatography and Oxygen Selective Flame Ionization Detection, approved October 1, 2010 ("ASTM D5599").
(xii) ASTM D5769 10, Standard Test
Method for Determination of Benzene,
Toluene, and Total Aromatics in Finished
Gasolines by
Gas Chromatography/Mass Spectrometry, approved
May 1, 2010 ("ASTM D5769").
(xiii) ASTM D6550-10, Standard Test
Method for Determination of Olefin
Content of Gasolines by SupercriticalFluid Chromatography, approved October 1, 2010 ("ASTM D6550").
(xiv) ASTM D6667 10, Standard Test
Method for Determination of Total
Volatile Sulfur in Gaseous Hydrocarbons and Liquefied Petroleum Gases
by Ultraviolet Fluorescence, approved
October 1, 2010 ("ASTM D6667").
(xv) ASTM D6920 13, Standard Test
Method for Total Sulfur in Naphthas,
Distillates, Reformulated Gasolines,
Diesels, Biodiesels, and Motor Fuels by
Oxidative Combustion and Electrochemical Detection, approved September 15, 2013 ("ASTM D6920").
(xvi) ASTM D7039 13, Standard Test
Method for Sulfur in Gasoline, Diesel
Fuel, Jet Fuel, Kerosine, Biodiesel,
Biodiesel Blends, and Gasoline-Ethanol
Blends by Monochromatic Wavelength
Dispersive X-ray Fluorescence Spectrometry, approved September 15, 2013
("ASTM D7039").
(2) [Reserved]
[59 FR 7813, Feb. 16, 1994, as amended at 59
FR 36961, July 20, 1994; 61 FR 58306, Nov. 13,
1996; 63 FR 63793, Nov. 17, 1998; 65 FR 6822,
Feb. 10, 2000; 65 FR 53189, Sept. 1, 2000; 66 FR
17263, Mar. 29, 2001; 67 FR 8737, Feb. 26, 2002;
67 FR 40181, June 12, 2002; 68 FR 56781, Oct. 2,
2003; 68 FR 57819, Oct. 7, 2003; 71 FR 16499,
Apr. 3, 2006; 73 FR 74355, Dec. 8, 2008; 74 FR
6233, Feb. 6, 2009; 76 FR 65385, Oct. 21, 2011; 79
FR 23632, Apr. 28, 2014; 80 FR 9090, Feb. 19,
2015]
40 CFR Ch. 1 (7-1-17 Edition)
§ 80.47 Performance-based Analytical
Test Method Approach.
All sample handling, testing procedures, and tests must be conducted
using good laboratory practices.
(a) Definitions. As used in this subpart
D:
(1) Performance-based Analytical Test
Method Approach means a measurement
system based upon established performance criteria for accuracy and precision with use of analytical test methods. As used in this subpart, this is a
measurement system used by laboratories to demonstrate that a particular
analytical test method is acceptable
for demonstrating compliance.
(2) Accuracy means the closeness of
agreement between an observed value
from a single test measurement and an
accepted reference value.
(3) Precision means the degree of
agreement in a set of measurements
performed on the same property of
identical test material.
(4) Absolute fuel parameter means a
fuel parameter for which a gravimetric
standard is practical to construct and
use. Sulfur content of gasoline, butane,
or diesel fuel are examples of an absolute fuel parameter.
(5) Gravimetric standard means a test
material made by adding a carefully
weighed quantity of the analyte to a
measured quantity of another substance known not to contain any of the
analyte, resulting in a solution with an
accurately known concentrate of the
analyte.
(6) Consensus named fuels 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.
(7) Locally-named reference materials
are gasoline or diesel fuels that are
usually from the regular production of
the facility where they are used in laboratory quality control efforts and
have been analyzed using the designated method (either by the facility's
lab or by a reference lab) to obtain an
estimate of their concentration.
(8)
Method-defined fuel parameter
means a fuel parameter for which an
Environmental Protection Agency
EPA-prescribed primary test method or
designated method defines the regulatory standard. Examples of methoddefined fuel parameters include olefin
content in gasoline, Reid vapor pressure (RVP) of gasoline, distillation parameters of gasoline, benzene content
of gasoline, aromatic content of gasoline and diesel fuel, and oxygen/
oxygenates content of gasoline.
(9) Reference installations are designated test method installations that
are used to qualify the accuracy of
other method-defined parameter instruments. Reference installations of
the designated test method will be used
to evaluate the accuracy of other
method-defined alternative test methods and to establish correlation equations if necessary.
(10) Correlation equation is a correction equation as determined by the use
of ASTM D6708. This standard practice
determines whether the comparison between the alternative test method and
the designated test method is a null result. If the comparison is not null, then
the standard practice provides for a
correlation equation that predicts designated test method results from the
applicable method-defined alternative
test method.
(11) Statistical quality control (SQC)
means a planned system of activities
whose purpose is to provide a level of
quality that meets the needs of compliance with the standards of this part.
This subpart prescribes specific SQC
requirements for both absolute and
method driven fuel parameters for both
voluntary
and non-voluntary
consensus-based standards bodies.
(12) Voluntary consensus-based standards body (VCSB) means a domestic or
international organization that plans,
develops, establishes, or coordinates
voluntary consensus standards using
agreed-upon procedures and which possesses the attributes of openness, balance of interest, due process, and consensus, as explained in OMB Circular
A 119 and the National Technology
Transfer and Advancement Act of 1995,
P.L. 104-113, sec. 12(d).
(13)
Non-voluntary consensus-based
standards body (non-VCSB) means a domestic or international regulated party
that has developed a proprietary ana-
§ 80.47
lytical test method that has not been
adopted by a VCSB organization.
(b) Precision and accuracy criteria for
approval for the absolute fuel parameter
of gasoline sulfur (1) Precision. Beginning January 1, 2016, for motor vehicle
gasoline, gasoline blendstock, and gasoline fuel additives subject to the gasoline sulfur standard at §§80.195 and
80.1603, the maximum allowable standard deviation computed from the results of a minimum of 20 tests made
over 20 days (tests may be arranged
into no fewer than five batches of four
or fewer tests each, with only one such
batch allowed per day over the minimum of 20 days) on samples using good
laboratory practices taken from a single homogeneous commercially available gasoline must be less than or
equal to 1.5 times the repeatability "r"
divided by 2.77, where "r" equals the
ASTM repeatability of ASTM D7039
(Example: A 10ppm sulfur gasoline
sample: Maximum allowable standard
deviation of 20 tests l.5*(1.73ppm!2.77) =
0.94 ppm). The 20 results must be a series of tests with a sequential record of
analysis and no omissions. A laboratory facility may exclude a given sample or test result only if the exclusion
is for a valid reason under good laboratory practices and it maintains records
regarding the sample and test results
and the reason for excluding them.
(2) Accuracy. Beginning January 1,
2016, for motor vehicle gasoline, gasoline blendstock, and gasoline fuel additives subject to the gasoline sulfur
standard at §§ 80.195 and 80.1603:
(i) The arithmetic average of a continuous series of at least 10 tests performed using good laboratory practices
on
a
commercially
available
gravimetric sulfur standard in the
range of 1 10 ppm, say 10 ppm, shall not
differ from the accepted reference
value (ARV) of the standard by more
than 0.70 ppm sulfur;
(ii) The arithmetic average of a continuous series of at least 10 tests performed using good laboratory practices
on
a
commercially
available
gravimetric sulfur standard in the
range of 10 20 ppm, say 20 ppm, shall
not differ from the ARV of the standard by more than 1.02 ppm sulfur; and
(iii) In applying the tests of paragraphs (b)(2)(i) and (ii) of this section,
§ 80.47
individual test results shall be compensated for any known chemical
interferences using good laboratory
practices.
(3) The test method specified at
§80.46(a)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraphs (b)(1) and (2) of
this section.
(c) Precision and accuracy criteria for
approval of the absolute fuel parameter of
sulfur in butane (1) Precision. Beginning January 1, 2016, for butane subject
to the butane sulfur standard at
§§80.82, 80.195, 80.340(b) and 80.1603, the
maximum allowable standard deviation
computed from the results of a minimum of 20 tests made over 20 days
(tests may be arranged into no fewer
than five batches of four or fewer tests
each, with only one such batch allowed
per day over the minimum of 20 days)
on samples using good laboratory practices taken from a single homogeneous
commercially available butane must be
less than or equal to 1.5 times the repeatability (r) divided by 2.77, where
"r" equals the ASTM repeatability of
ASTM D6667 (Example: A 10 ppm sulfur
butane sample: Maximum allowable
standard
deviation
of
20
tests<1.5*(l.15ppm/2.77) = 0.62 ppm). The
20 results must be a series of tests with
a sequential record of analysis and no
omissions. A laboratory facility may
exclude a given sample or test result
only if the exclusion is for a valid reason under good laboratory practices
and it maintains records regarding the
sample and test results and the reason
for excluding them.
(2) Accuracy. Beginning January 1,
2016, for butane subject to the butane
sulfur standard
at §§80.82,
80.195,
80.340(b) and 80.1603
(i) The arithmetic average of a continuous series of at least 10 tests performed using good laboratory practices
on
a
commercially
available
gravimetric sulfur standard in the
range of 1 10 ppm, say 10 ppm, shall not
differ from the accepted reference
value (ARV) of the standard by more
than 0.47 ppm sulfur;
(ii) The arithmetic average of a continuous series of at least 10 tests performed using good laboratory practices
on
a
commercially
available
gravimetric sulfur standard in the
40 CFR Ch. 1 (7-1-17 Edition)
range of 10 20 ppm, say 20 ppm, shall
not differ from the accepted reference
value (ARV) of the standard by more
than 0.94 ppm sulfur; and
(iii) In applying the tests of paragraphs (c)(2)(i) and (ii) of this section,
individual test results shall be compensated for any known chemical
interferences using good laboratory
practices.
(3) The test method specified at
§80.46(a)(2) and in use prior to October
28, 2013 is exempt from the requirements of paragraphs (c)(1) and (2) of
this section.
(d) Precisioncriteria for approval of the
method defined fuel parameter of olefins
in gasoline (1) Precision. Beginning
January 1, 2016, for motor vehicle gasoline, gasoline blendstock, and gasoline
fuel additives subject to the gasoline
standards of this part, the maximum
allowable standard deviation computed
from the results of a minimum of 20
tests made over 20 days (tests may be
arranged into no fewer than five
batches of four or fewer tests each,
with only one such batch allowed per
day over the minimum of 20 days) on
samples using good laboratory practices taken from a single homogeneous
commercially available gasoline must
be less than or equal to 0.3 times the
reproducibility (R), where "R" equals
the ASTM reproducibility of ASTM
D1319 (Example: A gasoline containing
9 Vol% olefins: Maximum allowable
standard deviation of 20 tests <0.3*(3.06
Vol%) = 0.92 Vol%). The 20 results must
be a series of tests with a sequential
record of analysis and no omissions. A
laboratory facility may exclude a given
sample or test result only if the exclusion is for a valid reason under good
laboratory practices and it maintains
records regarding the sample and test
results and the reason for excluding
them.
(2) The test method specified at
§80.46(b)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraph (d)(1) of this section.
(e) Precision criteriafor approval of the
method defined fuel parameter of aromatics in gasoline (1) Precision. Beginning January 1, 2016, for motor vehicle
Environmental Protection Agency
gasoline, gasoline blendstock, and gasoline fuel additives subject to the gasoline standards of this part, the maximum allowable standard deviation
computed from the results of a minimum of 20 tests made over 20 days
(tests may be arranged into no fewer
than five batches of four or fewer tests
each, with only one such batch allowed
per day over the minimum of 20 days)
on samples using good laboratory practices taken from a single homogeneous
commercially available gasoline must
be less than or equal to 0.3 times the
reproducibility (R), where "R" equals
the ASTM reproducibility of ASTM
D1319 (Example: A gasoline containing
32Vol% aromatics: Maximum allowable
standard deviation of 20 tests <0.3*(3.7
Vol%) = 1.11Vol%). The 20 results must
be a series of tests with a sequential
record of analysis and no omissions. A
laboratory facility may exclude a given
sample or test result only if the exclusion is for a valid reason under good
laboratory practices and it maintains
records regarding the sample and test
results and the reason for excluding
them.
(2) The test method specified at
§80.46(f)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraph (e)(1) of this section.
(f) Precision criteria for approval of the
method defined fuel parameter of oxygen
and oxygenate content in gasoline (1)
Precision. Beginning January 1, 2016, for
motor
vehicle
gasoline,
gasoline
blendstock, and gasoline fuel additives
subject to the gasoline standards of
this part, the maximum allowable
standard deviation computed from the
results of a minimum of 20 tests made
over 20 days (tests may be arranged
into no fewer than five batches of four
or fewer tests each, with only one such
batch allowed per day over the minimum of 20 days) on samples using good
laboratory practices taken from a single homogeneous commercially available gasoline must be less than or
equal to 0.3 times the reproducibility
(R), where "R" equals the ASTM reproducibility of ASTM D5599 (Example: A
gasoline containing 3Mass% total oxygen: Maximum allowable standard deviation of 20 tests <0.3*(0.32 Mass%) =
0.10 Mass%). The 20 results must be a
§ 80.47
series of tests with a sequential record
of analysis and no omissions. A laboratory facility may exclude a given sample or test result only if the exclusion
is for a valid reason under good laboratory practices and it maintains records
regarding the sample and test results
and the reason for excluding them.
(2) The test method specified at
§80.46(g)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraph (f)(1) of this section.
(g) Precisioncriteria for approval of the
method defined fuel parameter of Reid
Vapor Pressure (RVP) in gasoline (1)
Precision. Beginning January 1, 2016, for
motor
vehicle
gasoline,
gasoline
blendstock, and gasoline fuel additives
subject to the gasoline standards of
this part and volatility standards at
§80.27, the maximum allowable standard deviation computed from the results of a minimum of 20 tests made
over 20 days (tests may be arranged
into no fewer than five batches of four
or fewer tests each, with only one such
batch allowed per day over the minimum of 20 days) on samples using good
laboratory practices taken from a single homogeneous commercially available gasoline must be less than or
equal to 0.3 times the reproducibility
(R), where "R" equals the ASTM reproducibility of ASTM D5191 (Example: A
gasoline having a RVP of 6.8psi: Maximum allowable standard deviation of
20 tests withdrawn from a 250 milliliter
container <0.3*(0.40psi) = 0.12 psi). The
20 results must be a series of tests with
a sequential record of analysis and no
omissions. A laboratory facility may
exclude a given sample or test result
only if the exclusion is for a valid reason under good laboratory practices
and it maintains records regarding the
sample and test results and the reason
for excluding them.
(2) The test method specified at
§80.46(c)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraph (g)(1) of this section.
(h) Precision criteriafor approval of the
method defined fuel parameter of gasoline
distillation (1)
Precision. Beginning
January 1, 2016, for motor vehicle gasoline, gasoline blendstock, and gasoline
fuel additives subject to the gasoline
§ 80.47
standards of this part, the maximum
allowable standard deviation computed
from the results of a minimum of 20
tests made over 20 days (tests may be
arranged into no fewer than five
batches of four or fewer tests each,
with only one such batch allowed per
day over the minimum of 20 days) on
samples using good laboratory practices taken from a single homogeneous
commercially available gasoline must
be less than or equal to 0.3 times the
reproducibility (R), where "R" equals
the ASTM reproducibility in Table 10,
Groups 2, 3 and 4 (Automated) of ASTM
D86 07 for the initial boiling point, El0,
E50, E90 and final boiling point. (Example: A gasoline having an initial boiling point of 26 'C and a final boiling
point of 215 'C: Maximum allowable
standard deviation of 20 tests for initial boiling point <0.3*(8.5 'C) = 2.55 'C,
maximum allowable standard deviation
of 20 tests for El0 <0.3*(3.0 + 2.64*Sc) 'C,
maximum allowable standard deviation
of 20 tests for E50 _0.3*(2.9 + 3.97*Sc) 'C,
maximum allowable standard deviation
of 20 tests for E90 <0.3*(2.0 + 2.53*Sc) 'C,
and maximum allowable standard deviation of 20 tests for final boiling point
<0.3*(10.5 °C) = 3.15 'C), where Sc is the
average slope (or rate of change) of the
gasoline distillation curve as calculated in accordance with section 13.2
of ASTM D86-07. The 20 results must be
a series of tests with a sequential
record of analysis and no omissions.
Note that the precision criteria described in this paragraph (h)(1) differ
from what is specified in ASTM D86 12.
A laboratory facility may exclude a
given sample or test result only if the
exclusion is for a valid reason under
good laboratory practices and it maintains records regarding the sample and
test results and the reason for excluding them.
(2) The test method specified at
§80.46(d)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraph (h)(1) of this section.
(i) Precision criteria for approval of the
method defined fuel parameter of benzene
in gasoline (1) Precision. Beginning
January 1, 2016, for motor vehicle gasoline, gasoline blendstock, and gasoline
fuel additives subject to the gasoline
standards of this part and MSAT2
40 CFR Ch. 1 (7-1-17 Edition)
standards at §§80.41, 80.101, 80.1230, the
maximum allowable standard deviation
computed from the results of a minimum of 20 tests made over 20 days
(tests may be arranged into no fewer
than five batches of four or fewer tests
each, with only one such batch allowed
per day over the minimum of 20 days)
on samples using good laboratory practices taken from a single homogeneous
commercially available gasoline must
be less than or equal to 0.15 times the
reproducibility (R), where "R" equals
the ASTM reproducibility of ASTM
D3606 (Example: A gasoline having a
lVol% benzene: Maximum allowable
standard deviation of 20 tests <0.15*(0.18
Vol%) = 0.027Vol%). The 20 results
must be a series of tests with a sequential record of analysis and no omissions. A laboratory facility may exclude a given sample or test result only
if the exclusion is for a valid reason
under good laboratory practices and it
maintains records regarding the sample and test results and the reason for
excluding them.
(2) The test method specified at
§80.46(e)(1) and in use prior to October
28, 2013 is exempt from the requirements of paragraph (i)(1) of this section.
(j) Precision criteria for approval of the
method defined fuel parameter of aromatics in diesel (1) Precision. Beginning
January 1, 2016, for motor vehicle diesel fuel subject to the motor vehicle
diesel standards at §80.520, the maximum allowable standard deviation
computed from the results of a minimum of 20 tests made over 20 days
(tests may be arranged into no fewer
than five batches of four or fewer tests
each, with only one such batch allowed
per day over the minimum of 20 days)
on samples using good laboratory practices taken from a single homogeneous
commercially
available
diesel fuel
must be less than or equal to 0.3 times
the reproducibility (R), where "R"
equals the ASTM reproducibility of
ASTM D1319 (Example: A diesel fuel
containing 35 Vol% aromatics: maximum allowable standard deviation of
20 tests <0.3*(3.3 Vol%) = 0.99Vol%). The
20 results must be a series of tests with
a sequential record of analysis and no
omissions. A laboratory facility may
exclude a given sample or test result
Environmental Protection Agency
only if the exclusion is for a valid reason under good laboratory practices
and it maintains records regarding the
sample and test results and the reason
for excluding them.
(2) The test method specified at
§80.2(z) and in use prior to October 28,
2013 is exempt from the requirements
of paragraph (j)(1) of this section.
(k) Criteria for designated test method
reference installations used to qualify the
accuracy of other method-defined parameter instruments. (1) Beginning January
1, 2016, for a single laboratory test facility qualifying a method defined alternative test method, the reference installation of the method-defined fuel
parameter for the applicable designated test method must have precision equal to 0.3 times the reproducibility (R) of the method-defined fuel
parameter's designated test method,
where "I" is the reproducibility of the
designated test method.
(i) For olefins in gasoline, see paragraph (d)(1) of this section.
(ii) For aromatics in gasoline, see
paragraph (e)(1) of this section.
(iii) For oxygen and oxygenate content of gasoline, see paragraph (f)(1) of
this section.
(iv) For Reid Vapor Pressure (RVP)
of gasoline, see paragraph (g)(1) of this
section.
(v) For gasoline distillation, see
paragraph (h)(1) of this section.
(vi) For benzene in gasoline, see paragraph (i)(1) of this section.
(vii) For aromatics in diesel fuel, see
paragraph (j)(1) of this section.
(2) The reference installation of the
method-defined fuel parameter for the
applicable
designated
test method
must be shown to stay within the middle 50% of the distribution of an industry or commercially available monthly
inter-laboratory crosscheck program
for 3 out of 5 successive exchanges for
at least a period of five months using
good laboratory practices. Specifically,
compute the difference between the instrument's average measurement of
the fuel closest to the applicable fuel
standard (or to the average value for
the fuel parameter in the complex
model) and the mean for that fuel obtained by all of the non-outlier labs in
the
monthly
inter-laboratory
crosscheck program. Standardize this
§ 80.47
difference by expressing it in standard
deviation units. These standardized
inter-laboratory crosscheck differences
should be placed in a moving average
with a minimum span of five months.
The instrument's moving average in
standard deviation units cannot be outside the central 50% of the distribution
of all laboratories that participated in
the inter-laboratory crosscheck program.
(3) The reference installation of the
method-defined fuel parameter for the
applicable
designated
test method
must be shown to be in statistical quality control as specified in ASTM D6299
for a minimum period of five months
using good laboratory practices. The
system is still considered to be in statistical quality control and the five
month time period will not re-start if
(i) Regular maintenance and/or recalibration conducted during the five
months in SQC qualification time period is considered as part of in-control
normal operation, and/or;
(ii) If an assignable cause for 'out of
control' is found, mitigated, and the
system is brought back in statistical
quality control during the five month
time period that the reference installation is attempting to meet the five
month in-statistical-control requirement, the five month time period does
not re-start and the system is still considered to be 'in-control'.
(4) For a voluntary consensus standards body, such as ASTM, or for a commercially
available
industry
crosscheck program, the summary statistics (mean and standard error standard deviation/square root [number
of results]) from the VCSB or commercially available inter-laboratory crosscheck program (ILCP) data may be
used as is without imposing the reference installations requirements of
this section, provided that the number
of non-outlying results is greater than
16 for both the designated and alternative test methods. The determination of ARV of check standards as specified in ASTM D6299, clause 6.2.2.1 and
Note 7 shall be followed for the interlaboratory crosscheck program. The
use of VCSB or commercially available
ILCP data as described above is deemed
suitable for an ASTM D6708 assessment
of VCSB alternative test methods.
§ 80.47
(1) Qualification criteria for Voluntary
Consensus Standard Based (VCSB) Method-Defined Parameter Test Methods and
Non-voluntary Consensus Standard Based
(non-VCSB) Absolute Fuel Parameter of
Sulfur in Gasoline and Butane. (1)(i) Beginning January 1, 2016, the test facility or VCSB include full test method
documentation by the Voluntary Consensus Standard Based (VCSB) organization, including a description of the
technology
and/or
instrumentation
that makes the method functional.
(ii) For the Non-voluntary Consensus
Standard Based (non-VCSB) Absolute
Fuel Parameter of Sulfur in Gasoline
and Butane, the test facility include
full test method documentation, including a description of the technology
and/or instrumentation that makes the
method functional.
(2)(i) The test facility or VCSB include information reported in the test
method that demonstrates the test
method meets the applicable precision
information for the method-defined
fuel parameter as described in this section.
(ii) For the Non-VCSB absolute fuel
parameter of sulfur in gasoline and butane, the test facility include information reported in the test method that
demonstrates the applicable accuracy
criteria as described in §80.47(b)(2) for
gasoline and §80.47(c)(2) for butane.
(3) The test facility or VCSB include
information reported in the test method that demonstrates the test method
has been evaluated using ASTM D6708
and whether the comparison is a "null"
result or whether a correlation equation needs to be applied that predicts
designated test method results from
the applicable method-defined alternative test method.
(4) The test methods specified at
§§80.2(w) and 80.46(a)(1), (a)(2), (b)(1),
(c)(1), (d)(1), (e)(1), (f)(1), and (g)(1) and
in use by a test facility prior to October 28, 2013 are exempt from the requirements of paragraphs (1)(1) through
(3) of this section.
(m) Qualification criteria for Non-Voluntary Consensus Standard Based (nonVCSB) Method-Defined Parameter Test
Methods. For a non-VCSB method to be
approved, the following information
must be submitted to the Administrator by each test facility for each
40 CFR Ch. 1 (7-1-17 Edition)
method that it wishes to have approved.
(1) Beginning January 1, 2016, full and
thorough test method documentation,
including a description of the technology and/or instrumentation that
makes the method functional so a person lacking experience with the test instrument would be able to replicate its
results.
(2) Information reported in the test
method that demonstrates the test
method meets the applicable precision
information using good laboratory
practices for the method-defined fuel
parameter as described in this section.
(3) Both the candidate method-defined Non-VCSB test method and its respective designated test method must
be tested on a range of consensus
named fuels or locally-named reference
materials that are typical of those analyzed by the facility in practice using
good laboratory practices and must
meet the data requirements for variability as required in ASTM D6708.
(4) The facility using the candidate
method-defined non-VCSB test method
must statistically establish through
application of ASTM D6708 that the
candidate method measures the same
aspect of samples as applicable to its
respective
designated
test method
using good laboratory practices.
(5) If the use of ASTM D6708 reveals
that the candidate method-defined
non-VCSB test method has sample-specific biases due to matrix effects that
cannot be determined as random the
method is disqualified. If however, it is
determined that the candidate methoddefined non-VCSB test method can be
qualified on a narrow circumscribed
range of fuels while still meeting the
data requirements for variability as required in ASTM D6708 (see paragraph
(m)(3) of this section), then the types of
fuels on which the qualification was
achieved and for which the method is
to be approved must be specified in the
candidate method-defined non-VCSB
test method description. If there is any
restriction on the scope of fuels for
which the candidate method-defined
non-VCSB test method is to be qualified, the applicant must include a discussion of how the facility plans to
screen sample for conformity to the
scope. If the candidate method-defined
Environmental Protection Agency
test method is found to have minimal
matrix effects, a statement to this effect must be included by the applicant
in its application.
(6) The candidate method-defined
non-VCSB test method precision qualification must be conducted in the form
of "between methods reproducibility"
(Rcm) of the candidate method and applicable designated test method as recommended in ASTM D6708, where the
Rem must be equal to or less than 70
percent of the published reproducibility of the applicable designated test
method using good laboratory practices.
(7) The applicant of the candidate
method-defined non-VCSB test method
must demonstrate through the use of
ASTM D6708 whether a correlation to
applicable designated test method is
necessary. If it is determined through
the use of this practice that the candidate method-defined non-VCSB test
method requires a correlation equation
in order to predict designated test
method results, then this correlation
equation must be applied to the candidate instruments output to obtain
measurement results for regulatory
purposes using good laboratory practices.
(8) Any additional information requested by the Administrator and necessary to render a decision as to approval of the test method.
(9) Samples used for precision and accuracy determination must be retained
for 90 days.
(10) Within 90 days of the receipt of
materials required to be submitted
under paragraphs (m)(1) through (9) of
this section, the Administrator shall
determine whether the test method is
approved under this section.
(11) If the Administrator denies approval of the test method, within 90
days of receipt of all materials required to be submitted in paragraphs
(m)(1) through (9) of this section, the
Administrator will notify the applicant
of the reasons for not approving the
method. If the Administrator does not
notify the applicant within 90 days of
receipt of the application, then the test
method shall be deemed approved.
(12) The Administrator may revoke
approval of a test method under this
section for cause, including, but not
§ 80.47
limited to, a determination by the Administrator that the approved test
method has proved to be inadequate in
practice.
(13) An independent third-party scientific review and written report and
verification of the information provided pursuant to paragraphs (m)(1)
through (9) of this section. The report
and verification shall be based upon a
site visit and review of relevant documents and shall separately identify
each item required by paragraphs
(m)(1) through (9) of this section, describe how the independent third-party
evaluated the accuracy of the information provided, state whether the independent third-party agrees with the information provided, and identify any
exceptions between the independent
third-party's findings and the information provided.
(i) The information required under
this section must be conducted by an
independent third party who is a professional chemist and statistician, or
who is a chemical engineer, with the
following qualifications:
(A) For a refiner, importer, oxygenate producer, and oxygenate blender,
the independent third party must have
at least a bachelor's degree in chemistry and statistics, or at least a bachelor's degree in chemical engineering,
from an accredited college in the
United States, or the independent third
party must be a subject matter expert
with equivalent knowledge and qualification, with professional work experience in the petroleum or oxygenate
field, especially with a demonstrated
good working knowledge of ASTM
D6708 and ASTM D6299.
(B) [Reserved]
(ii) To be considered an independent
third-party
under
this
paragraph
(m)(13):
(A) The third-party shall not be employed by the refiner, importer, oxygenate producer, or oxygenate blender,
or any subsidiary or employee of the
refiner, import facility, oxygenate producing facility, or oxygenate blender.
(B) The third party shall be free from
any interest in the refiner's, importer's, oxygenate producer's, or oxygenate blender's business.
(C) The refiner, importer, oxygenate
producer, or oxygenate blender shall be
§ 80.47
free from any interest in the third-party's business.
(D) Use of a third-party that is
debarred, suspended, or proposed for
debarment pursuant to the Government-wide Debarment and Suspension
regulations, 40 CFR part 32, or the Debarment, Suspension and Ineligibility
provisions of the Federal Acquisition
Regulations, 48 CFR part 9 subpart 9.4,
shall be deemed in noncompliance with
the requirements of this section.
(iii) The independent third-party
shall retain all records pertaining to
the verification required under this
section for a period of five years from
the date of creation and shall deliver
such records to the Administrator upon
request.
(iv) The independent third party
must provide EPA documentation of
his or her qualifications as described in
this paragraph (m) as part of the scientific review.
(14) If the Administrator finds that
an individual test facility has provided
false or inaccurate information under
this section, upon notice from the Administrator the approval shall be void
ab initio.
(n) Accuracy and Precision Statistical
Quality Control (SQC) Requirements for
the Absolute Fuel Parameters.Beginning
January 1, 2016, a test shall not be considered a test using an approved test
method unless the following quality
control procedures are performed separately for each instrument used to
make measurements:
(1)(i) Accuracy SQC. Every facility
shall conduct tests on every instrument with a commercially available
gravimetric
reference
material, or
check standard as defined in ASTM
D6299 at least three times a year using
good laboratory practices. The facility
must pre-treat and assess results from
the check standard testing after at
least 15 testing occasions as described
in section 8.2 of this standard practice.
The facility must construct "MR" and
"I" charts with control lines as described in section 8.4 and appropriate
Annex sections of this standard practice. In circumstances where the absolute difference between the mean of
multiple back-to-back tests of the
standard reference material and the accepted reference value of the standard
40 CFR Ch. 1 (7-1-17 Edition)
reference material is greater than 0.75
times the published reproducibility of
the test method, the cause of such difference must be investigated by the facility. Records of the standard reference materials measurements as well
as any investigations into any exceedance of these criteria must be kept for
a period of five years.
(ii) The expanded uncertainty of the
accepted reference value of consensus
named fuels shall have the following
accuracy qualification criterion: Accuracy qualification criterion = square
root [(0.75R)A2 + (0.75R)A2/L], where L the number of single results obtained
from different labs used to calculate
the consensus ARV.
(2)(i) Precision SQC. Every facility
shall conduct tests on every instrument with a quality control material
as defined in paragraph 3.2.8 in ASTM
D6299 either once per week or once per
every 20 production tests, whichever is
more frequent. The facility must construct and maintain an "I" chart as described in section 8 and section A1.5.1
and a "MR" chart as described in section A1.5.4. Any violations of control
limit(s) should be investigated by personnel of the facility and records kept
for a period of five years.
(ii) Validation of New QC Material.
When a test facility is making a transition from one batch of QC material to
the next batch of QC material, the facility will either construct an "I"
chart as described in section 8.7 and
section A1.5.1 of ASTM D6299, or follow
the "Q-Procedure" in Annex 1.9 of
ASTM D6299. In following the Q-Procedure, if the plot of results from the
"old" and "new" QC materials on its
respective chart shows no special-cause
signals, then the result of the "new"
QC material will be considered valid.
(iii) For test facilities opting to use
the Q-procedure, the first run on the
new QC batch should be validated by
either an overlap in-control result of
the old batch, or by a single execution
of an accompanying standard reference
material. The new QC material result
would be considered validated if the
single result of the standard reference
material is within the established site
precision (R') of the Accepted Reference Value of the standard reference
Environmental Protection Agency
material, as determined by ASTM
D6792.
(iv) [Reserved]
(v) These records must be kept by the
facility for a period of five years.
(o) Accuracy and Precision Statistical
Quality Control (SQC) Requirements for
the Voluntary Consensus Standard Based
(VCSB) Method-Defined Fuel Parameters.
Beginning January 1, 2016, a test shall
not be considered a test using an approved test method unless the following quality control procedures are
performed separately for each instrument used to make measurements:
(1)(i) Accuracy SQC. Every facility
shall conduct tests of every instrument
with a commercially available check
standard as defined in ASTM D6299 at
least three times a year using good laboratory practices. The check standard
must be an ordinary fuel with levels of
the fuel parameter of interest close to
either the applicable regulatory standard or the average level of use for the
facility. For facilities using a VCSB
designated method defined test method, the Accepted Reference Value of
the check standard must be determined
by the respective designated test method for the fuel parameter following the
guidelines of ASTM D6299. Facilities
using a VCSB alternative method defined test method must use the Accepted Reference Value of the check standard as determined in a VCSB Inter Laboratory Crosscheck Program (ILCP) or
a commercially available ILCP following the guidelines of ASTM D6299. If
the Accepted Reference Value is not
provided in the ILCP, accuracy must be
assessed based upon the respective
EPA-designated test method using appropriate production samples. The facility must pre-treat and assess results
from the check standard testing after
at least 15 testing occasions as described in section 8.2 of this standard
practice. The facility must construct
"MR" and "I" charts with control lines
as described in section 8.4 and appropriate Annex sections of this standard
practice. In circumstances where the
absolute difference between the mean
of multiple back-to-back tests of the
standard reference material and the accepted reference value of the standard
reference material is greater than 0.75
times the published reproducibility of
§ 80.47
the test method, the cause of such difference must be investigated by the facility. Participation in a VCSB ILCP at
least three times a year satisfies this
Accuracy SQC requirement (Examples
of ILCP: ASTM Reformulated Gasoline
ILCP or ASTM motor gasoline ILCP).
Records of the standard reference materials measurements as well as any investigations into any exceedance of
these criteria must be kept for a period
of five years.
(ii) The expanded uncertainty of the
accepted reference value of consensus
named fuels shall have the following
accuracy qualification criterion: Accuracy qualification criterion = square
root [(0.75R)A2 + (0.75R)A2/L], where L the number of single results obtained
from different labs used to calculate
the consensus ARV.
(2)(i) Precision SQC. Every facility
shall conduct tests of every instrument
with a quality control material as defined in paragraph 3.2.8 in ASTM D6299
either once per week or once per every
20 production tests, whichever is more
frequent. The facility must construct
and maintain an "I" chart as described
in section 8 and section A1.5.1 and a
"MR" chart as described in section
A1.5.4. Any
violations of control
limit(s) should be investigated by personnel of the facility and records kept
for a period of five years.
(ii) Validation of New QC Material.
When a test facility is making a transition from one batch of QC material to
the next batch of QC material, the facility will either construct an
I"
chart as described in section 8.7 and
section A1.5.1 of ASTM D6299, or follow
the "Q-Procedure" in Annex 1.9 of
ASTM D6299. In following the Q-Procedure if the plot of results from the
"old" and "new" QC materials on its
respective chart shows no special-cause
signals, then the result of the "new"
QC material will be considered valid.
(iii) For test facilities opting to use
the Q-procedure, the first run on the
new QC batch should be validated by
either an overlap in-control result of
the old batch, or by a single execution
of an accompanying standard reference
material. The new QC material result
would be considered validated if the
single result of the standard reference
material is within the established site
§ 80.47
precision (R') of the Accepted Reference Value of the standard reference
material, as determined by ASTM
D6792.
(iv) [Reserved]
(v) These records must be kept by the
facility for a period of five years.
(p) Accuracy and Precision Statistical
Quality Control (SQC) Requirements for
the Non-Voluntary Consensus Standard
Based (Non-VCSB) Method-Defined Fuel
Parameters. Beginning January 1, 2016,
a test shall not be considered a test
using an approved test method unless
the following quality control procedures are performed separately for each
instrument used to make measurements:
(1)(i) Accuracy SQC for Non-VCSB
Method-Defined test methods with minimal matrix effects. Every facility shall
conduct tests on every instrument with
a commercially available check standard as defined in the ASTM D6299 at
least three times a year using good laboratory practices. The check standard
must be an ordinary fuel with levels of
the fuel parameter of interest close to
either the applicable regulatory standard or the average level of use for the
facility. Facilities using a Non-VCSB
alternative method defined test method must use the Accepted Reference
Value of the check standard as determined in either a VCSB Inter Laboratory Crosscheck Program (ILCP) or a
commercially available ILCP following
the guidelines of ASTM D6299. If the
Accepted Reference Value is not provided in the ILCP, accuracy must be
assessed based upon the respective EPA
designated test method using appropriate production samples. The facility
must pre-treat and assess results from
the check standard testing after at
least 15 testing occasions as described
in section 8.2 of this standard practice.
The facility must construct "MR" and
"I" charts with control lines as described in section 8.4 and appropriate
Annex sections of this standard practice. In circumstances where the absolute difference between the mean of
multiple back-to-back tests of the
standard reference material and the accepted reference value of the standard
reference material is greater than 0.75
times the published reproducibility of
the fuel parameter's respective des-
40 CFR Ch. 1 (7-1-17 Edition)
ignated test method, the cause of such
difference must be investigated by the
facility. Records of the standard reference materials measurements as well
as any investigations into any exceedance of these criteria must be kept for
a period of five years.
(ii) The expanded uncertainty of the
accepted reference value of consensus
named fuels shall have the following
accuracy qualification criterion: Accuracy qualification criterion = square
root [(0.75R)A2 + (0.75R)A2/L], where L the number of single results obtained
from different labs used to calculate
the consensus ARV.
(2)(i) Accuracy SQC for Non-VCSB
Method-Defined test methods with high
sensitivity to matrix effects. Every facility shall conduct tests on every instrument with a production fuel on at least
a quarterly basis using good laboratory
practices. The production fuel must be
representative of the production fuels
that are routinely analyzed by the facility. The Accepted Reference Value
of the production fuel must be determined by the respective reference installation of the designated test method for the fuel parameter following the
guidelines of ASTM D6299. The facility
must pre-treat and assess results from
the check standard testing after at
least 15 testing occasions as described
in section 8.2 of this standard practice.
The facility must construct "MR" and
"I" charts with control lines as described in section 8.4 and appropriate
Annex sections of this standard practice. In circumstances where the absolute difference between the mean of
multiple back-to-back tests of the
standard reference material and the accepted reference value of the standard
reference material is greater than 0.75
times the published reproducibility of
the test method must be investigated
by the facility. Documentation on the
identity of the reference installation
and its control status must be maintained on the premises of the methoddefined
alternative
test
method.
Records of the standard reference materials measurements as well as any investigations into any exceedances of
this criterion must be kept for a period
of five years.
(ii) Each facility is required to send
every 20th production batch of gasoline
Environmental Protection Agency
or diesel fuel to EPA's laboratory,
along with the facility's measurement
result used to certify the batch using
the respective method-defined nonVCSB test method. The EPA retains
the right to return such sample on a
blind basis for a required reanalysis on
the respective method-defined nonVCSB test method within 180 days upon
receipt of such sample.
(3)(i) Precision SQC. Every facility
shall conduct tests on every instrument with a quality control material
as defined in paragraph 3.2.8 in ASTM
D6299 either once per week or once per
every 20 production tests, whichever is
more frequent. The facility must construct and maintain an "I" chart as described in section 8 and section A1.5.1
and a "MR" chart as described in section A1.5.4. Any violations of control
limit(s) should be investigated by personnel of the facility and records kept
for a period of five years.
(ii) Validation of New QC Material.
When a test facility is making a transition from one batch of QC material to
the next batch of QC material, the facility will either construct an
I"
chart as described in section 8.7 and
section A1.5.1 of ASTM D6299, or follow
the "Q-Procedure" in Annex 1.9 of
ASTM D6299. In following the Q-Procedure, if the plot of results from the
"old" and "new" QC materials on its
respective chart shows no special-cause
signals, then the result of the "new"
QC material will be considered valid.
(iii) For test facilities opting to use
the Q-procedure, the first run on the
new QC batch should be validated by
either an overlap in-control result of
the old batch, or by a single execution
of an accompanying standard reference
material. The new QC material result
would be considered validated if the
single result of the standard reference
material is within the established site
precision (R') of the Accepted Reference Value of the standard reference
material, as determined by ASTM
D6792.
(iv) [Reserved]
(v) These records must be kept by the
facility for a period of five years.
(q) Record retention requirements for
the test methods approved under this subpart. Each individual test facility must
retain records related to the establish-
§ 80.47
ment of accuracy and precision values,
all test method documentation, and
any statistical quality control testing
and analysis under this section using
good laboratory practices for a period
for five years.
(r) Materials incorporated by reference.
The published materials identified in
this section are incorporated by reference into this section with the approval of the Director of the Federal
Register under 5 U.S.C. 552(a) and 1
CFR part 51. To enforce any edition
other than that specified in this section, a document must be published in
the FEDERAL REGISTER and the material must be available to the public. All
approved materials are available for inspection at the Air and Radiation
Docket and Information Center (Air
Docket) in the EPA Docket Center
(EPA/DC) at Rm. 3334, EPA West Bldg.,
1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the
telephone number for the Air Docket is
(202) 566-1742. These approved materials
are also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at
NARA, call (202) 741 6030 or go to http://
www.archives.gov/federal register/
code of federal regulations/
ibr locations.html. In addition, these
materials
are available
from the
sources listed below.
(1) ASTM International material. The
following standards are available from
ASTM International, 100 Barr Harbor
Dr., P.O. Box C700, West Conshohocken,
PA 19428 2959, (877) 909 ASTM, or http://
www.astm.org:
(i) ASTM D86-07, Standard Test
Method for Distillation of Petroleum
Products at Atmospheric Pressure, approved January 15, 2007 ("ASTM D86").
(ii) ASTM D1319 13, Standard Test
Method for Hydrocarbon Types in Liquid Petroleum Products by Fluorescent
Indicator Adsorption, approved May 1,
2013 ("ASTM D1319").
(iii) ASTM D3606-10, Standard Test
Method for Determination of Benzene
and Toluene in Finished Motor and
§ 80.48
Aviation Gasoline by Gas Chromatography, approved October 1, 2010
("ASTM D3606").
(iv) ASTM D5191 13, Standard Test
Method for Vapor Pressure of Petroleum Products (Mini Method), approved December 1, 2013 ("ASTM
D5191").
(v) ASTM D5599-00 (Reapproved 2010),
Standard Test Method for Determination of Oxygenates in Gasoline by Gas
Chromatography and Oxygen Selective
Flame Ionization Detection, approved
October 1, 2010 ("ASTM D5599").
(vi) ASTM D6299 13, Standard Practice for Applying Statistical Quality
Assurance and Control Charting Techniques to Evaluate Analytical Measurement
System Performance,
approved October 1, 2013 ("ASTM D6299").
(vii) ASTM D6667 10, Standard Test
Method for Determination of Total
Volatile Sulfur in Gaseous Hydrocarbons and Liquefied Petroleum Gases
by Ultraviolet Fluorescence, approved
October 1, 2010 ("ASTM D6667").
(viii) ASTM D6708 13, Standard Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purport
to Measure the Same Property of a Material, approved May 1, 2013 ("ASTM
D6708").
(ix) ASTM D6792 13, Standard Practice for Quality System in Petroleum
Products and Lubricants Testing Laboratories,
approved
May 15, 2013
("ASTM D6792").
(x) ASTM D7039 13, Standard Test
Method for Sulfur in Gasoline, Diesel
Fuel, Jet Fuel, Kerosine, Biodiesel,
Biodiesel Blends, and Gasoline-Ethanol
Blends by Monochromatic Wavelength
Dispersive X-ray Fluorescence Spectrometry, approved September 15, 2013,
("ASTM D7039").
(2) [Reserved]
[79 FR 23633, Apr. 28, 2014, as amended at 80
FR 9091, Feb. 19, 2015]
§ 80.48 Augmentation of the complex
emission model by vehicle testing.
(a) The provisions of this section
apply only if a fuel claims emission reduction benefits from fuel parameters
that are not included in the complex
emission model or complex emission
model database, or if the values of fuel
parameters included in the complex
40 CFR Ch. 1 (7-1-17 Edition)
emission model set forth in §80.45 fall
outside the range of values for which
the complex emission model is deemed
valid.
(b) To augment the complex emission
model described at § 80.45, the following
requirements apply:
(1) The petitioner must obtain prior
approval from the Administrator for
the design of the test program before
beginning the vehicle testing process.
To obtain approval, the petitioner
must at minimum provide the following information: the fuel parameter
to be evaluated for emission effects;
the number and description of vehicles
to be used in the test fleet, including
model year, model name, vehicle identification number (VIN), mileage, emission performance (exhaust THC emission level), technology type, and manufacturer; a description of the methods
used to procure and prepare the vehicles; the properties of the fuels to be
used in the testing program (as specified at §80.49); the pollutants and emission categories intended to be evaluated; the precautions used to ensure
that the effects of the parameter in
question are independent of the effects
of other parameters already included in
the model; a description of the quality
assurance procedures to be used during
the test program; the statistical analysis techniques to be used in analyzing
the test data, and the identity and location of the organization performing
the testing.
(2) Exhaust emissions shall be measured per the requirements of this section and §80.49 through §80.62.
(3) The nonexhaust emission model
(including evaporative, running loss,
and refueling VOC and toxics emissions) shall not be augmented by vehicle testing.
(4) The Agency reserves the right to
observe and monitor any testing that
is performed pursuant to the requirements of this section.
(5) The Agency reserves the right to
evaluate the quality and suitability of
data submitted pursuant to the requirements of this section and to reject, re-analyze, or otherwise evaluate
such data as is technically warranted.
(6) Upon a showing satisfactory to
the Administrator, the Administrator
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?