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40 C.F.R. §§ 1090.1360–1090.1375

4 sections in range

§1090.1360. Performance-based Measurement System.

40 C.F.R. § 1090.1360

(a)
The Performance-based Measurement System (PBMS) is an approach that allows for laboratory testing with any procedure that meets specified performance criteria. This subpart specifies the performance criteria for measuring certain fuel parameters to demonstrate compliance with the standards and other specifications of this part. These provisions do not apply to process stream analyzers used with in-line blending.
(b)
Different requirements apply for absolute fuel parameters and method-defined fuel parameters.
(1)
Absolute fuel parameters are those for which it is possible to evaluate measurement accuracy by comparing measured values of a test sample to a reference sample with a known value for the measured parameter. The following are absolute fuel parameters:
(i)
Sulfur.
(ii)
[Reserved]
(2)
Method-defined fuel parameters are all those that are not absolute fuel parameters. Additional test provisions apply for method-defined fuel parameters under this section because there is no reference sample for evaluating measurement accuracy.
(c)
The performance criteria of this section apply as follows—
(1)
Section 1090.1365 specifies the initial qualifying criteria for all measurement procedures. You may use an alternative procedure only if testing shows that you meet the initial qualifying criteria.
(2)
Section 1090.1375 specifies ongoing quality testing requirements that apply for a laboratory that uses either referee procedures or alternative procedures.
(3)
Streamlined requirements for alternative procedures apply for procedures adopted by a voluntary consensus standards body (VCSB). Certification testing with non-VCSB procedures requires advance approval by EPA. Procedures are considered non-VCSB testing as follows:
(i)
Procedures developed by individual companies or other parties are considered non-VCSB procedures.
(ii)
Draft procedures under development by a VCSB organization are considered non-VCSB procedures until they are approved for publication.
(iii)
A published procedure is considered non-VCSB for testing with fuel parameters that fall outside the range of values covered in the research report of the ASTM D6708 (incorporated by reference in § 1090.95) assessment comparing candidate alternative procedures to the referee procedure specified in paragraph (d) of this section.
(4)
You may use updated versions of the referee procedures as alternative procedures subject to the limitations of § 1090.1365(a)(2). You may ask EPA for approval to use an updated version of the referee procedure for qualifying other alternative procedures if the updated referee procedure has the same or better repeatability and reproducibility compared to the version specified in § 1090.95. If the updated procedure has worse repeatability or reproducibility compared to the earlier version, you must complete the required testing specified in § 1090.1365 using the older, referenced version of the referee procedure.
(5)
Any laboratory may use the specified referee procedure without qualification testing. To use alternative procedures at a given laboratory, you must perform the specified testing to demonstrate compliance with precision and accuracy requirements, with the following exceptions:
(i)
Testing you performed to qualify alternative procedures under 40 CFR part 80 continues to be valid for making the demonstrations required in this part.
(ii)
Qualification testing is not required for a laboratory that measures the benzene content of gasoline using Procedure B of ASTM D3606 (incorporated by reference in § 1090.95). However, qualification testing may be necessary for updated versions of this procedure as specified in § 1090.1365(a)(2).
(d)
Referee procedures are presumed to meet the initial qualifying criteria in this section. You may use alternative procedures if you qualify them using the referee procedures as a benchmark as specified in § 1090.1365. The following are the referee procedures:
Notes, amendments, and revision history

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4361, Jan. 15, 2025]

Authority

Authority: 42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.

Source

Source: 85 FR 78469, Dec. 4, 2020, unless otherwise noted.

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4361, Jan. 15, 2025]

§1090.1365. Qualifying criteria for alternative measurement procedures.

40 C.F.R. § 1090.1365

This section specifies how to qualify alternative procedures for measuring absolute and method-defined fuel parameters under the Performance-based Measurement System specified in § 1090.1360.
(a)
The following general provisions apply for qualifying alternative procedures—
(1)
Alternative procedures must have appropriate precision to allow for reporting to the number of decimal places specified in § 1090.1350(c).
(2)
Testing to qualify an alternative procedure applies for the specified version of the procedure you use for making the necessary measurements. For referee procedures and for alternative procedures for method-defined fuel parameters that you have qualified for your laboratory, updated versions of those same procedures are qualified without further testing, as long as the specified reproducibility is the same as or better than the values specified in the earlier version. For absolute fuel parameters, updated versions are qualified without testing if both repeatability and reproducibility are the same as or better than the values specified in the earlier version.
(3)
Except as specified in paragraph (d) of this section, testing to demonstrate compliance with the precision and accuracy specifications in this section apply only for the laboratory where the testing occurred. At a given laboratory, qualifying a test method applies for all associated instruments used for testing to certify fuel.
(4)
If a procedure for measuring benzene or sulfur in gasoline has no published PLOQ and no published scope with a lower bound, you must establish a LLOQ.
(5)
Testing for method-defined fuel parameters must take place at a reference installation as specified in § 1090.1370.
(b)
All alternative procedures must meet precision criteria based on a calculated maximum allowable standard deviation for a given fuel parameter as specified in this paragraph (b). The precision criteria apply for measuring the parameters and fuels specified in paragraph (b)(4) of this section. Take the following steps to qualify the measurement procedure for measuring a given fuel parameter:
(1)
The fuel must meet the parameter specifications in table 1 to paragraph (b)(4) of this section. This may require that you modify the fuel you typically produce to be within the specified range. Absent a specification (maximum or minimum), select a fuel representing values that are typical for your testing. Store and mix the fuel to maintain a homogenous mixture throughout the measurement period to ensure that each fuel sample drawn from the batch has the same properties.
(2)
Measure the fuel parameter from a homogeneous fuel batch at least 20 times. Record each result in sequence. Do not omit any valid results unless you use good engineering judgment to determine that the omission is necessary and you document those results and the reason for excluding them. Perform this analysis over a 20-day period. You may make up to 4 separate measurements in a 24-hour period, as long as the interval between measurements is at least 4 hours. Do not measure RVP more than once from a single sample.
(3)
An alternative procedure for measuring oxygenate in gasoline must account for every type of oxygenate covered by the referee method.
(4)
Calculate the maximum allowable standard deviation as follows—
(c)
Alternative VCSB procedures for measuring absolute fuel parameters (sulfur) must meet accuracy criteria based on the following measurement procedure:
(1)
Obtain gravimetric sulfur standards to serve as representative reference samples. The samples must have known sulfur content within the ranges specified in paragraph (c)(3) of this section. The known sulfur content is the accepted reference value (ARV) for the fuel sample.
(2)
Measure the sulfur content of the fuel sample at your laboratory at least 10 times, without interruption. Use good laboratory practice to compensate for any known chemical interferences; however, you must apply that same compensation for all tests to measure the sulfur content of a test fuel. Calculate the arithmetic average of all the measured values, including any compensation.
(3)
The measurement procedure meets the accuracy requirement as follows—
(i)
Demonstrate accuracy for measuring sulfur in gasoline and butane using samples to represent sulfur values from 1 to 10 ppm, 11 to 20 ppm, and 21 to 95 ppm. You may omit any of these ranges if you do not perform testing with fuel in that range. Calculate the maximum allowable difference between the average measured value and the ARV for each applicable range as follows:
(ii)
Demonstrate accuracy for measuring sulfur in diesel fuel using test fuels meeting the specifications in table 2 to this section. For testing diesel fuel-related blendstocks and additives, use representative test samples meeting the appropriate sulfur specification. Table 2 to this paragraph also identifies the maximum allowable difference between average measured value and the ARV corresponding to the ARV at the upper end of each specified range. These values are based on calculations with the equation in paragraph (c)(3)(i) of this section, with parameter values set equal to the standard.
(d)
Alternative VCSB procedures for measuring method-defined fuel parameters must meet accuracy criteria as follows:
(1)
You may use the alternative procedure only if you follow all the statistical protocols and meet all the criteria specified in Section 6 of ASTM D6708 (incorporated by reference in § 1090.95) when comparing your measurements using the alternative procedure to measurements at a reference installation using the appropriate referee procedure identified in § 1090.1360(d).
(2)
For qualifying alternative procedures, determine whether the alternative procedure needs a correlation equation to correct bias relative to the reference test method. Create such a correlation equation as specified in Section 7 of ASTM D6708. For all testing, apply the correlation equation to adjust measured values to be statistically consistent to measuring with the reference test method.
(3)
If an alternative VCSB procedure states that the procedure has a successful assessment relative to the referee procedures in this section under ASTM D6708, that finding applies for all laboratories using that procedure.
(e)
Alternative non-VCSB procedures for measuring absolute fuel parameters (sulfur) must meet accuracy criteria as follows:
(1)
Demonstrate whether the procedure meets statistical criteria and whether it needs a correlation equation as specified in paragraphs (d)(1) and (2) of this section. Apply the correlation equation for all testing with the alternative procedure.
(2)
Demonstrate at your laboratory that the alternative procedure meets the accuracy criteria specified in paragraph (c) of this section.
(3)
Send EPA a written request to use the alternative procedure. In your request, fully describe the procedure to show how it functions for achieving accurate measurements and include detailed information related to your assessment under paragraph (e)(1) and (2) of this section.
(f)
Alternative non-VCSB procedures for measuring method-defined fuel parameters must meet accuracy and precision criteria as follows:
(1)
Demonstrate whether the procedure meets statistical criteria and whether it needs a correlation equation as specified in paragraphs (e)(1) and (2) of this section. Apply the correlation equation for all testing with the alternative procedure.
(2)
Test with a range of fuels that are typical of those you will analyze at your laboratory. Use either consensus-named fuels or locally named reference materials. Consensus-named fuels are homogeneous fuel quantities sent around to different laboratories for analysis, which results in a “consensus name” representing the average value of the parameter for all participating laboratories. Locally named reference materials are fuel samples analyzed using the reference test method, either at your laboratory or at a reference installation, to establish an estimated value for the fuel parameter; locally named reference materials usually come from the fuel you produce.
(3)
You may qualify your procedure as meeting the requirements of paragraph (f)(1) of this section only for a narrower, defined range of fuels. If this is the case, identify the appropriate range of fuels in your request for approval and describe how you will screen fuel samples accordingly.
(4)
Qualify the precision of the alternative procedure by comparing results to testing with the referee procedure based on “between methods reproducibility,” Rxy, as specified in ASTM D6708. The Rxy must be at or below 75 percent of the reproducibility of the referee procedure in § 1090.1360(d).
(5)
Perform testing at your laboratory as specified in paragraph (b) of this section to establish the repeatability of the alternative procedure. The repeatability must be as good as or better than that specified in paragraph (b)(4) of this section.
(6)
Fully describe the procedure to show how it functions for achieving accurate measurements. Describe the technology, test instruments, and testing method so a competent person lacking experience with the procedure and test instruments would be able to replicate the results.
(7)
Engage a third-party auditor to review and verify your information as follows—
(i)
The auditor must qualify as an independent third party and meet the specifications for technical ability as specified in § 1090.55.
(ii)
The auditor must send you a report describing their inspection of your laboratories and their review of the information supporting your request to use the alternative procedure. The report must describe how the auditor performed the review, identify any errors or discrepancies, and state whether the information supports a conclusion that the alternative procedure should be approved.
(iii)
The auditor must keep records related to the review for at least 5 years after sending you the report and provide those records to EPA upon request.
(8)
Send EPA a written request to use the alternative procedure. Include the specified information and any additional information EPA needs to evaluate your request.
(g)
Keep fuel samples from any qualification testing under this section for at least 180 days after you have taken all steps to qualify an alternative procedure under this section. This applies for testing at your laboratory and at any reference installation you use for demonstrating the accuracy of an alternative procedure.
Notes, amendments, and revision history

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4361, Jan. 15, 2025]

Authority

Authority: 42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.

Source

Source: 85 FR 78469, Dec. 4, 2020, unless otherwise noted.

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4361, Jan. 15, 2025]

§1090.1370. Qualifying criteria for reference installations.

40 C.F.R. § 1090.1370

(a)
A reference installation refers to a laboratory that uses the referee procedure specified in § 1090.1360(d) to evaluate the accuracy of alternative procedures for method-defined parameters, by comparing measured values to companion tests using one of the referee procedures in § 1090.1360(d). This evaluation may result in an equation to correlate results between the two procedures. Once a laboratory qualifies as a reference installation, that qualification is valid for five years from the qualifying date, consistent with good laboratory practices.
(b)
You may qualify a reference installation for VCSB procedures by participating in an inter-laboratory crosscheck program with at least 16 separate measurements that are not identified as outliers. This presumes that the results for the candidate reference installation are not outliers.
(c)
You may qualify a reference installation for VCSB or non-VCSB procedures based on the following measurement protocol:
(1)
Use the precision testing procedure specified in § 1090.1365(b) to show that your standard deviation for tests using the reference test method is at or below 0.3 times the reproducibility for a given fuel parameter.
(2)
You must correlate your test results for a given fuel parameter against the accepted reference values from a monthly crosscheck program based on Section 6.2.2.1 and Note 7 of ASTM D6299 (incorporated by reference in § 1090.95) as follows:
(i)
If there are multiple fuels available from the crosscheck program, select the fuel that has the closest value to the standard. If there is no standard for a given fuel parameter, select the fuel with values for the fuel parameter that best represent typical values for fuels you test.
(ii)
Measure the fuel parameter for the crosscheck fuel at your laboratory using the appropriate referee procedure. Calculate a mean value that includes all your repeat measurements.
(iii)
Determine the mean value from the crosscheck program and calculate the difference between this value and the mean value from your testing. Express this difference as a certain number of standard deviations relative to the data set from the crosscheck program.
(iv)
The calculated monthly difference between the mean values from § 1090.1365(c)(3)(ii) for 5 consecutive months must fall within the central 50 percent of the distribution of data at least 3 times. The central 50 percent of the distribution corresponds to 0.68 standard deviations.
(v)
Calculate the mean value of the differences from § 1090.1365(c)(3)(ii) for all 5 months. This mean value must fall within the central 50 percent of the distribution of data from the crosscheck program. For example, if the difference was 0.5 standard deviations for two months, 0.6 for one month, and 0.7 for two months, the mean value of the difference is 0.6 standards deviations, and the reference installation meets the requirements of this paragraph.
(3)
You must demonstrate that the reference installation is in statistical quality control for at least 5 months with the designated procedure as specified in ASTM D6299. If at any point the reference installation is not in statistical quality control, you must make any necessary changes and restart testing toward meeting the requirement to achieve statistical quality control for at least 5 months, except as follows:
(i)
Do not consider measurements you perform as part of regular maintenance or recalibration for evaluating statistical quality control.
(ii)
If you find that the reference installation is not in statistical quality control during an initial 5-month period and you are able to identify the problem and make the necessary changes to again achieve statistical quality control before the end of the 5-month demonstration period, you may consider the reference installation as meeting the requirement to be in statistical quality control for at least 5 months.
Notes, amendments, and revision history

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4363, Jan. 15, 2025]

Authority

Authority: 42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.

Source

Source: 85 FR 78469, Dec. 4, 2020, unless otherwise noted.

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4363, Jan. 15, 2025]

§1090.1375. Quality control procedures.

40 C.F.R. § 1090.1375

This section specifies ongoing quality testing requirements as part of the Performance-based Measurement System specified in § 1090.1360.
(a)
General provisions. You must perform testing to show that your laboratory meets specified precision and accuracy criteria as follows:
(1)
The testing requirement applies for the referee procedures in § 1090.1360(d) and for alternate procedures that are qualified or approved under § 1090.1365. The testing requirements apply separately for each test instrument at each laboratory.
(2)
If you fail to conduct specified testing, your test instrument is not qualified for measuring fuel parameters to demonstrate compliance with the standards and other specifications of this part until you perform this testing. Similarly, if your test instrument fails to meet the specified criteria, it is not qualified for measuring fuel parameters to demonstrate compliance with the standards and other specifications of this part until you make the necessary changes to your test instrument and perform testing to show that the test instrument again meets the specified criteria.
(3)
If you perform major maintenance such as overhauling an instrument, confirm that the instrument still meets precision and accuracy criteria before you start testing again based on the procedures specified in ASTM D6299 (incorporated by reference in § 1090.95).
(4)
Keep records to document any test results excluded for being out of control under Section 8.5 and A1.5.4.1 of ASTM D6299. Identify the assignable cause and include any appropriate additional supporting justification.
(5)
Keep records to document your testing under this section for 5 years.
(b)
Precision demonstration. Show that you meet precision criteria as follows:
(1)
Meeting the precision criteria of this paragraph (b) qualifies your test instrument for performing up to 20 tests or 7 days, whichever is less. Include all tests except for testing to meet precision or accuracy requirements.
(2)
Perform precision testing using the control-chart procedures in ASTM D6299. If you opt to use procedure 2A (Q-Procedure) or 2B (dynamically updated exponentially weighted moving average), validate the first run on the new QC batch 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 ARV of the standard reference material.
(3)
Use I charts and MR charts as specified in ASTM D6299 to show that the standard deviation for the test instrument meets the precision criteria specified in § 1090.1365(b).
(c)
Accuracy demonstration. For absolute fuel parameters (VCSB and non-VCSB) and for method-defined fuel parameters using non-VCSB methods, you must show that you meet accuracy criteria as specified in this paragraph (c). For method-defined VCSB procedures, you may meet accuracy requirements as specified in this paragraph (c) or by comparing your results to the accepted reference value in an inter-laboratory crosscheck program as specified in paragraph (d) of this section.
(1)
Meeting the accuracy criteria of this paragraph (c) qualifies your test instrument for 130 days.
(2)
Except as specified in paragraph (c)(3) of this section, test every instrument using a check standard meeting the specifications of ASTM D6299. Select a fuel sample with an ARV representing fuel that is typical for your testing.
(3)
The following provisions apply for method-defined non-VCSB alternative procedures with high sensitivity to sample-specific bias:
(i)
Procedures have high sensitivity if the closeness sum of squares (CSS) statistic exceeds the 95th percentile value, as specified in ASTM D6708 (incorporated by reference in § 1090.95).
(ii)
Create a check standard from production fuel representing the fuel you will routinely analyze. Determine the ARV of your check standard using the protocol in ASTM D6299 at a reference installation as specified in § 1090.1370.
(iii)
You must send EPA a fuel sample from every twentieth batch of gasoline or diesel fuel and identify the procedures and corresponding test results from your testing. EPA may return one of your samples to you for further testing; if this occurs, you must repeat your measurement and report your results within 180 days of receiving the fuel sample.
(4)
You meet accuracy requirements under this section if the difference between your measured value for the check standard and the ARV is less than the value from the following equation:
(d)
Demonstrating accuracy by participating in crosscheck programs. You may meet accuracy requirements under paragraph (c) of this section by comparing your results to the accepted reference value in an inter-laboratory crosscheck program sponsored by ASTM International or another VCSB at least three times per year (two times per year for RVP), subject to the following provisions:
(1)
Your results from the crosscheck program are not valid for demonstrating compliance with accuracy requirements for a test instrument under this section if any of the following apply:
(i)
The crosscheck program does not have a robust ARV based on the check standard requirements in Section 6.2 of ASTM D6299.
(ii)
The difference between the test result and the ARV is greater than the maximum allowable difference in paragraph (c)(4) of this section.
(iii)
The measured value lies outside of the three-sigma range for the data from the relevant inter-laboratory crosscheck program.
(2)
If your results from the crosscheck program are not valid under paragraph (a)(1) of this section, perform a root cause analysis and document your findings and the steps you take to correct the problem. You continue to meet accuracy requirements under this section for the affected parameter only if you correct the problem and demonstrate compliance with the accuracy requirements of this section within 45 days after learning of a failure under paragraph (d)(1) of this section. The compliance demonstration may be based on in-house testing using a check standard qualified by a third party, on a non-VCSB correlation program administered by a third party, or on testing in the next crosscheck program.
(e)
Failure to meet precision or accuracy requirements. The presumed values specified in § 1090.1710(g) apply relative to certification for parameter measurements with test instruments failing to meet precision or accuracy requirements under this section. If you fail to meet the deadlines for resolving crosscheck-related issues under paragraph (d)(2) of this section, the presumed values apply relative to certification for parameter measurements with the test instruments failing to meet precision or accuracy requirements starting at the point of learning of a failure under paragraph (d)(1) of this section.
Notes, amendments, and revision history

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4363, Jan. 15, 2025]

Authority

Authority: 42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.

Source

Source: 85 FR 78469, Dec. 4, 2020, unless otherwise noted.

Amendments

[85 FR 78469, Dec. 4, 2020, as amended at 90 FR 4363, Jan. 15, 2025]