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From: Joe Sopata, Chemist, USEPA/OAR/OTAQ/CD/FCC

Through: John Weihrauch, Center Director, USEPA/OAQ/OTAQ/CD/FCC

To: Docket Number EPA-HQ-OAR-2011-0135

Subject: Supplemental Proposed Regulations: Performance Based Measurement System 

Date: 12/21/2011

The following are proposed regulations as discussed in section i.ii, Option 2, Agency

Approval of All Test Methods, in the preamble of this proposed rule.

5. Section 80.47 is revised to read as follows:

§ 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:

(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, 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 

referee lab) to obtain an estimate of their concentration.

(8) Method-defined fuel parameter means a fuel parameter for which an EPA-prescribed 

primary test method or “designated method” defines the regulatory standard. Examples 

of method-defined 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.
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(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 

International standard practice D6708 (incorporated by reference, see paragraph (r) of 

this section). 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 Part 

80. This subpart prescribes specific SQC requirements for both absolute and method 

driven fuel parameters for both VCSB and non-VCSB regulated parties. 

(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 whose analytical test method is not adopted by a VCSB 

organization.

(b) Precision and accuracy criteria for approval for the absolute fuel parameter of gasoline 

sulfur.

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline 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 (7 or fewer tests per week and 2 or fewer tests per day) 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 D7039-07 (Example: A 10ppm sulfur 

gasoline sample: maximum allowable standard deviation of 20 

tests≤1.5*(1.75ppm/2.77)=0.95 ppm). The 20 results must be a series of tests with a 

sequential record of analysis and no emissions. 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 November 30, 2014, for motor vehicle gasoline 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 shall not differ from the accepted reference value (ARV) of the standard by 

more than 0.71 ppm sulfur;
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(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 shall not differ from the accepted reference value (ARV) of the standard by

more than 1.00 ppm sulfur; and

(iii) In applying the tests of paragraphs (b)(2)(i) and (b)(2)(ii) of this section, individual test 

results shall be compensated for any known chemical interferences using good laboratory

practices.

(3) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(4) Samples used for precision and accuracy determination must be retained for 90 days.

(5) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (b)(1) through (4) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(6) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (b)(1) through (4) 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.

(7) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(c) Precision and accuracy criteria for approval of the absolute fuel parameter of sulfur in 

butane.

(1) Precision. Beginning November 30, 2014, for butane subject to the butane sulfur 

standard at §80.82 and §80.1603, the maximum allowable standard deviation computed 

from the results of a minimum of 20 tests made over 20 days (7 or fewer tests per week 

and 2 or fewer tests per day) 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 D6667-10 (Example: A 10ppm sulfur butane sample: maximum allowable 

standard deviation of 20 tests≤1.5*(1.15ppm/2.77)=0.62 ppm). The 20 results must be a 

series of tests with a sequential record of analysis and no emissions. 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 November 30, 2014, for butane subject to the butane sulfur 

standard at §80.82 and §0.1603:

(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 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 range 

of 10-20 ppm shall not differ from the accepted reference value (ARV) of the standard by 

more than 0.94ppm sulfur; and
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(iii) In applying the tests of paragraphs (c)(2)(i) and (c)(2)(ii) of this section, individual test 

results shall be compensated for any known chemical interferences using good laboratory

practices.

(3) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(4) Samples used for precision and accuracy determination must be retained for 90 days.

(5) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (c)(1) through (4) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(6) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (c)(1) through (4) 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.

(7) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(d) Precision criteria for approval of the method defined fuel parameter of olefins in 

gasoline?

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline and gasoline fuel 

additives subject to the gasoline standards of Part 80, the maximum allowable standard 

deviation computed from the results of a minimum of 20 tests made over 20 days (7 or 

fewer tests per week and 2 or fewer tests per day) 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 D1319-10 (Example: A gasoline containing 9Vol% 

olefins: maximum allowable standard deviation of 20 

tests≤1.5*(0.972Vol%/2.77)=0.53Vol%). The 20 results must be a series of tests with a 

sequential record of analysis and no emissions. 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (d)(1) through (3) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (d)(1) through (3) 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.
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(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(e) Precision criteria for approval of the method defined fuel parameter of aromatics in 

gasoline.

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline and gasoline fuel 

additives subject to the gasoline standards at Part 80, the maximum allowable standard 

deviation computed from the results of a minimum of 20 tests made over 20 days (7 or 

fewer tests per week and 2 or fewer tests per day) 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 D1319-10 (Example: A gasoline containing 32Vol% 

aromatics: maximum allowable standard deviation of 20 

tests≤1.5*(1.3Vol%/2.77)=0.70Vol%). The 20 results must be a series of tests with a 

sequential record of analysis and no emissions. 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (e)(1) through (4) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (e)(1) through (4) 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.

(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(f) Precision criteria for approval of the method defined fuel parameter of oxygen and 

oxygenate content in gasoline.

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline and gasoline fuel 

additives subject to the gasoline standards at Part 80, the maximum allowable standard 

deviation computed from the results of a minimum of 20 tests made over 20 days (7 or 

fewer tests per week and 2 or fewer tests per day) 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 5599-00(2010) (Example: A gasoline containing 3Mass% 

total oxygen: maximum allowable standard deviation of 20 

tests≤1.5*(0.083Mass%/2.77)=0.045Mass%). The 20 results must be a series of tests 

with a sequential record of analysis and no emissions. A laboratory facility may exclude 
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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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (f)(1) through (3) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (f)(1) through (3) 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.

(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(g) Precision criteria for approval of the method defined fuel parameter of Reid Vapor 

Pressure (RVP) in gasoline.

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline and gasoline fuel 

additives subject to the gasoline standards of Part 80, and the volatility standards at 

§80.27, the maximum allowable standard deviation computed from the results of a 

minimum of 20 tests made over 20 days (7 or fewer tests per week and 2 or fewer tests 

per day) 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 5191-10b 

(Example: A gasoline having a RVP of 6.8psi: maximum allowable standard deviation of 

20 tests≤1.5*(0.21psi/2.77)=0.11psi). The 20 results must be a series of tests with a 

sequential record of analysis and no emissions. 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (g)(1) through (3) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (g)(1) through (3) 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.
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(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(h) Precision criteria for approval of the method defined fuel parameter of gasoline 

distillation.

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline and gasoline fuel 

additives subject to the gasoline standards of Part 80, the maximum allowable standard 

deviation computed from the results of a minimum of 20 tests made over 20 days (7 or 

fewer tests per week and 2 or fewer tests per day) 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 D86-11a for the initial boiling point, E10, E50, E90 and 

final boiling point. (Example: A gasoline having an initial boiling point of 200C and a 

final boiling point of 1100C: maximum allowable standard deviation of 20 tests for initial 

boiling point≤1.5*(2.840C/2.77)=1.540C, maximum allowable standard deviation of 20 

tests for E10≤1.5*(1.330C/2.77)=0.720C, maximum allowable standard deviation of 20 

tests for E50≤1.5*(0.740C/2.77)=0.400C, maximum allowable standard deviation of 20 

tests for E90t≤1.5*(1.790C/2.77)=0.970C, and maximum allowable standard deviation of 

20 tests for final boiling point≤1.5*(3.330C/2.77)=1.800C ). The 20 results must be a 

series of tests with a sequential record of analysis and no emissions. 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (h)(1) through (3) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (h)(1) through (3) 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.

(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(i) Precision criteria for approval of the method defined fuel parameter of benzene in 

gasoline.

(1) Precision. Beginning November 30, 2014, for motor vehicle gasoline and gasoline fuel 

additives subject to the gasoline standards of Part 80 and theMSAT2 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 (7 or fewer tests per week and 2 or 

fewer tests per day) on samples using good laboratory practices taken from a single 
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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 

D3606-10 (Example: A gasoline having a 1Vol% benzene: maximum allowable standard 

deviation of 20 tests≤1.5*(0.04Vol%/2.77)=0.02Vol%). The 20 results must be a series 

of tests with a sequential record of analysis and no emissions. 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (i)(1) through (3) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (i)(1) through (3) 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.

(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(j) Precision criteria for approval of the method defined fuel parameter of aromatics in 

diesel.

(1) Precision. Beginning November 30, 2014, for motor vehicle diesel and diesel fuel 

additives 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 (7 or fewer tests per week and 2 or fewer tests per day) 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 D1319-10 (Example: A diesel fuel 

containing 35Vol% aromatics: maximum allowable standard deviation of 20 

tests≤1.5*(1.3Vol%/2.77)=0.70Vol%). The 20 results must be a series of tests with a 

sequential record of analysis and no emissions. 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(3) Samples used for precision and accuracy determination must be retained for 90 days.

(4) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (j)(1) through (3) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(5) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (j)(1) through (3) of this section, the 
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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.

(6) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(k) Criterion for designated test method reference installations used to qualify the accuracy

of other method-defined parameter instruments.

(1) Beginning November 30, 2014, the reference installation of the method-defined fuel 

parameter for the applicable designated test method must have precision equal to 1.5 

times the repeatability “r” of the method-defined fuel parameter’s designated test method, 

where “r” is the repeatability of the designated test method.

(i) Olefins in gasoline see §80.47(d)(1).

(ii) Aromatics in gasoline see §80.47(e)(1).

(iii) Oxygen and Oxygenate content of gasoline see §80.47(f)(1).

(iv) Reid Vapor Pressure (RVP) of gasoline see §80.47(g)(1).

(v) Gasoline Distillation see §80.47(h)(1).

(vi) Benzene in Gasoline see §80.47(i)(1)

(vii) Aromatics in Diesel see §80.47(j)(1).

(2) The reference installation of the method-defined fuel parameter for the applicable 

designated test method must be shown to be near the middle distribution of an industry

monthly inter-laboratory crosscheck program for at least a period of five months. 

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 robust mean for that fuel obtained by all of the 

non-outlier labs in the monthly inter-laboratory crosscheck program. Standardize this 

difference by expressing it in robust standard deviation units. These standardized interlaboratory crosscheck differences should be placed in a moving average with a minimum 

span of five months. The instrument’s moving average in robust 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 International D6299 (incorporated by reference, see paragraph (r) of this section) 

for a minimum period of five months.

(4) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(5) Samples used for precision and accuracy determination must be retained for 90 days.

(6) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (k)(1) through (5) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(7) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (k)(1) through (5) of this section, the 

Administrator will notify the applicant of the reasons for not approving the method. If 
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the Administrator does not notify the applicant within 90 days of receipt of the 

application, then the test method shall be deemed approved.

(8) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(l) Qualification criteria for Voluntary Consensus Standard Based (VCSB) Method-Defined 

Parameter Test Methods.

(1) Beginning November 30, 2014, 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.

(2) 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.

(3) Include information reported in the test method that demonstrates the test method has 

been evaluated using ASTM International D6708 (incorporated by reference, see 

paragraph (r) of this section) 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) Any additional information requested by the Administrator and necessary to render a 

decision as to approval of the test method.

(5) Samples used for precision and accuracy determination must be retained for 90 days.

(6) EPA approval. Within 90 days of the receipt of materials required to be submitted under 

paragraphs (l)(1) through (5) of this section, the Administrator shall determine whether 

the test method is approved under this section.

(7) If the Administrator denies approval of the test method, within 90 days of receipt of all 

materials required to be submitted in paragraphs (l)(1) through (5) 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.

(8) If the Administrator finds that an individual test facility has provide false or inaccurate 

information under this section, upon notice from the Administrator the approval shall be 

void ab initio.

(m) Qualification Criterion for Non-Voluntary Consensus Standard Based (non-VCSB) 

Method-Defined Parameter Test Methods. For such a method to be approved, the 

following information must be submitted to the Administrator by each test facility for 

each method that it wishes to have approved.

(1) Beginning November 30, 2014, 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 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 
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reference materials that are typical of those analyzed by the facility in practice and must 

meet the data requirements for variability as required in ASTM International D6708 

(incorporated by reference, see paragraph (r) of this section).

(4) The facility using the candidate method-defined non-VCSB test method must statistically

establish through application of ASTM D6708 (incorporated by reference, see paragraph 

(r) of this section) that the candidate method measures the same aspect of samples as 

applicable to its respective designated test method.

(5) If the use of ASTM D6708 (incorporated by reference, see paragraph (r) of this section) 

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 method-defined 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 International D6708 

(incorporated by reference, see paragraph (r) of this section) (see (m)(3)), 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 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 “cross-method reproducibility” (Rcm) of the candidate method 

and applicable designated test method as required in ASTM International D6708 

(incorporated by reference, see paragraph (r) of this section), where the Rcm must be 

equal to or less than 70 percent of the published reproducibility of the applicable 

designated test method.

(7) The applicant of the candidate method-defined non-VCSB test method must demonstrate 

through the use of ASTM D6708 (incorporated by reference, see paragraph (r) of this 

section) 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.

(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) EPA approval. 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

(12) The Administrator may revoke approval of a test method under this section for cause, 

including, but not 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 (m)(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 (m)(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 to be provided by an independent third 

party must be conducted by both a professional chemist and professional statistician as 

specified in paragraphs (m)(13)(i)(A) of this section. The verifying chemist and 

statistician must be:

(A) For a refiner, importer, oxygenate producer, and oxygenate blender, a 

chemist and statistician who has received at least a bachelor’s degree in science from an 

accredited college in the United States, with professional work experience in the 

petroleum or oxygenate field.

(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 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 third-party must provide to EPA documentation of his or her qualifications as 

part of the scientific review, including proof of appropriate college degree.

(14) If the Administrator finds that an individual test facility has provide 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 November 30, 2014, 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:
13

(1) Accuracy SQC. Every facility shall conduct tests of every instrument with a 

commercially available gravimetric reference material, or check standard as defined in 

the ASTM International standard practice D6299 (incorporated by reference, see 

paragraph (r) of this section) on at least a quarterly basis 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 reference material is 

greater than 0.75 times the published reproducibility of the test method 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 5 years.

(2) (i) Precision SQC. Each facility on every instrument tests a quality control material as 

defined in paragraph 3.2.3 in ASTM International D6299 (incorporated by reference, see 

paragraph (r) of this section) either once per week or once per every 20 productions tests, 

whichever is more frequent. The facility must construct and maintain an “I” chart as 

described in section 7 and section A1.5.1 and a “MR” chart as described in section 

A1.5.2. Any violations of control limit(s) should be investigated by personnel of the 

facility and records kept for a period of 5 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 follow the “QProcedure” in Annex 1.9 of ASTM International standard practice D6299 (incorporated 

by reference, see paragraph (r) of this section). In following the Q-Procedure if the plot 

of results from the old and new QC materials on its respective chart shows not specialcause signals, then the result of the new QC material will be considered valid. These 

records must be kept by the facility for a period of 5 years.

(o) Accuracy and Precision Statistical Quality Control (SQC) Requirements for the 

Voluntary Consensus Standard Based (VCSB) Method-Defined Fuel Parameters. 

Beginning November 30, 2014 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) Accuracy SQC. Every facility shall conduct tests of every instrument with a 

commercially available check standard as defined in the ASTM International standard

practice D6299 (incorporated by reference, see paragraph (r) of this section) on at least a 

quarterly basis 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. 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 International standard practice 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 
14

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. 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 5 years.

(2) (i) Precision SQC. Every facility shall conduct tests of every instrument with a quality

control material as defined in paragraph 3.2.3 in ASTM International D6299 

(incorporated by reference, see paragraph (r) of this section) either once per week or once 

per every 20 productions tests, whichever is more frequent using good laboratory

practices. The facility must construct and maintain an “I” chart as described in section 7 

and section A1.5.1 and a “MR” chart as described in section A1.5.2. Any violations of 

control limit(s) should be investigated by personnel of the facility and records kept for a 

period of 5 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 follow the “QProcedure” in Annex 1.9 of ASTM International standard practice D6299 (incorporated 

by reference, see paragraph (r) of this section). In following the Q-Procedure if the plot 

of results from the old and new” QC materials on its respective chart shows no specialcause signals, then the result of the new QC material will be considered valid. These 

records must be kept by the facility for a period of 5 years.

(p) Accuracy and Precision Statistical Quality Control (SQC) Requirements for the NonVoluntary Consensus Standard Based (Non-VCSB) Method-Defined Fuel Parameters. 

Beginning November 30, 2014, 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) Accuracy SQC for Non-VCSB Method-Defined test methods with minimal matrix 

effects. Every facility shall conduct test of every instrument with a commercially

available check standard as defined in the ASTM International standard practice D6299 

(incorporated by reference, see paragraph (r) of this section) on at least a quarterly basis

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. 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 International standard practice 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. 

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 5 years.
15

(2) (i) Accuracy SQC for Non-VCSB Method-Defined test methods with high sensitivity to 

matrix effects. Every facility shall conduct tests of 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 International standard practice D6299 (incorporated 

by reference, see paragraph (r) of this section). 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 “method-defined” alternative test method. 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 5 years.

(ii) Each facility is required to send every 20th production batch of gasoline or diesel fuel to 

EPA’s laboratory, along with the facility’s measurement result used to certify the batch 

using the respective method-defined non-VCSB test method. The EPA retains the right 

to return such sample on a blind basis for a required reanalysis on the respective methoddefined non-VCSB test method within 180 days upon receipt of such sample. 

(3) Precision SQC. Every facility shall conduct tests of every instrument with a quality

control material as defined in paragraph 3.2.3 in ASTM International D6299 

(incorporated by reference, see paragraph (r) of this section) either once per week or once 

per every 20 productions tests, whichever is more frequent using good laboratory

practices. The facility must construct and maintain an “I” chart as described in section 7 

and section A1.5.1 and a “MR” chart as described in section A1.5.2. Any violations of 

control limit(s) should be investigated by personnel of the facility and records kept for a 

period of 5 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 follow the “QProcedure” in Annex 1.9 of ASTM International standard practice D6299 (incorporated 

by reference, see paragraph (r) of this section). In following the Q-Procedure if the plot 

of results from the old and new QC materials on its respective chart shows no specialcause signals, then the result of the new QC material will be considered valid. These 

records must be kept by the facility for a period of 5 years.

(q) Record retention requirements for the test methods approved under this subpart.

(1) Each individual test facility must retain records related to the establishment 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.

(2) [Reserved]
16

(r) Materials incorporated by reference. The Director of the Federal Register approved the 

incorporation by reference of the documents listed in this section as prescribed in 5 

U.S.C. 552(a) and 1 CFR 51. Anyone may inspect copies at the U.S. EPA, Air and 

Radiation Docket and Information Center, 1301 Constitution Ave., N.W., Room B102, 

EPA West Building, Washington, DC, 20460, under EPA docket ID Number EPA-HQOAR-2011-0135, or at the National Archives and Records Administration (NARA). The 

telephone number for the Air Docket Public Reading Room is (202) 566-1742. 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.htm

l. For further information on these test methods, please contact the Environmental 

Protection Agency at 734-214-4582.

(1) ASTM International material. Anyone may purchase copies of these materials from the 

ASTM International (ASTM), 100 Barr Harbor Dr., West Conshohocken, PA 19428-

2959, or by contacting ASTM International customer service at 10-832-9585, or by

contacting the email address of service@astm.org from the ASTM International Web site 

of http://www.astm.org.

(i) ASTM International standard practice D6708-08 (“ASTM International D6708”), 

“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 December 15, 2008.

(ii) ASTM International standard practice D6299-10ε1 (“ASTM International D6708”), 

“Standard Practice for Applying Statistical Quality Assurance and Control Charting 

Techniques to Evaluate Analytical Measurement System Performance”, approved March 

1, 2010.