40 CFR § 1065.12 - Approval of alternate procedures.

§ 1065.12 Approval of alternate procedures.

(a) To get approval for an alternate procedure under § 1065.10(c), send the EPA Program Officer an initial written request describing the alternate procedure and why you believe it is equivalent to the specified procedure. Anyone may request alternate procedure approval. This means that an individual engine manufacturer may request to use an alternate procedure. This also means that an instrument manufacturer may request to have an instrument, equipment, or procedure approved as an alternate procedure to those specified in this part. We may approve your request based on this information alone, whether or not it includes all the information specified in this section. Where we determine that your original submission does not include enough information for us to determine that the alternate procedure is equivalent to the specified procedure, we may ask you to submit supplemental information showing that your alternate procedure is consistently and reliably at least as accurate and repeatable as the specified procedure.

(b) We may make our approval under this section conditional upon meeting other requirements or specifications. We may limit our approval, for example, to certain time frames, specific duty cycles, or specific emission standards. Based upon any supplemental information we receive after our initial approval, we may amend a previously approved alternate procedure to extend, limit, or discontinue its use. We intend to publicly announce alternate procedures that we approve.

(c) Although we will make every effort to approve only alternate procedures that completely meet our requirements, we may revoke our approval of an alternate procedure if new information shows that it is significantly not equivalent to the specified procedure.

If we do this, we will grant time to switch to testing using an allowed procedure, considering the following factors:

(1) The cost, difficulty, and availability to switch to a procedure that we allow.

(2) The degree to which the alternate procedure affects your ability to show that your engines comply with all applicable emission standards.

(3) Any relevant factors considered in our initial approval.

(d) If we do not approve your proposed alternate procedure based on the information in your initial request, we may ask you to send additional information to fully evaluate your request. While we consider the information specified in this paragraph (d) and the statistical criteria of paragraph (e) of this section to be sufficient to demonstrate equivalence, it may not be necessary to include all the information or meet the specified statistical criteria. For example, systems that do not meet the statistical criteria in paragraph (e) of this section because they have a small bias toward high emission results could be approved since they would not adversely affect your ability to demonstrate compliance with applicable standards.

(1) Theoretical basis. Give a brief technical description explaining why you believe the proposed alternate procedure should result in emission measurements equivalent to those using the specified procedure. You may include equations, figures, and references. You should consider the full range of parameters that may affect equivalence. For example, for a request to use a different NOX measurement procedure, you should theoretically relate the alternate detection principle to the specified detection principle over the expected concentration ranges for NO, NO2, and interference species. For a request to use a different PM measurement procedure, you should explain the principles by which the alternate procedure quantifies particulate mass similarly to the specified procedures.

(2) Technical description. Describe briefly any hardware or software needed to perform the alternate procedure. You may include dimensioned drawings, flowcharts, schematics, and component specifications. Explain any necessary calculations or other data manipulation.

(3) Procedure execution. Describe briefly how to perform the alternate procedure and recommend a level of training an operator should have to achieve acceptable results.

Summarize the installation, calibration, operation, and maintenance procedures in a step-by-step format. Describe how any calibration is performed using NIST-traceable standards or other similar standards we approve. Calibration must be specified by using known quantities and must not be specified as a comparison with other allowed procedures.

(4) Data-collection techniques. Compare measured emission results using the proposed alternate procedure and the specified procedure, as follows:

(i) Both procedures must be calibrated independently to NIST-traceable standards or to other similar standards we approve.

(ii) Include measured emission results from all applicable duty cycles. Measured emission results should show that the test engine meets all applicable emission standards according to specified procedures.

(iii) Use statistical methods to evaluate the emission measurements, such as those described in paragraph (e) of this section.

(e) Absent any other directions from us, use a t-test and an F-test calculated according to § 1065.602 to evaluate whether your proposed alternate procedure is equivalent to the specified procedure. We may give you specific directions regarding methods for statistical analysis, or we may approve other methods that you propose. Such alternate methods may be more or less stringent than those specified in this paragraph (e). In determining the appropriate statistical criteria, we will consider the repeatability of measurements made with the reference procedure. For example, less stringent statistical criteria may be appropriate for measuring emission levels being so low that they adversely affect the repeatability of reference measurements. We recommend that you consult a statistician if you are unfamiliar with these statistical tests. Perform the tests as follows:

(1) Repeat measurements for all applicable duty cycles at least seven times for each procedure. You may use laboratory duty cycles to evaluate field-testing procedures.

Be sure to include all available results to evaluate the precision and accuracy of the proposed alternate procedure, as described in § 1065.2.

(2) Demonstrate the accuracy of the proposed alternate procedure by showing that it passes a two-sided t-test. Use an unpaired t-test, unless you show that a paired t-test is appropriate under both of the following provisions:

(i) For paired data, the population of the paired differences from which you sampled paired differences must be independent. That is, the probability of any given value of one paired difference is unchanged by knowledge of the value of another paired difference. For example, your paired data would violate this requirement if your series of paired differences showed a distinct increase or decrease that was dependent on the time at which they were sampled.

(ii) For paired data, the population of paired differences from which you sampled the paired differences must have a normal (i.e., Gaussian) distribution. If the population of paired difference is not normally distributed, consult a statistician for a more appropriate statistical test, which may include transforming the data with a mathematical function or using some kind of non-parametric test.

(3) Show that t is less than the critical t value, tcrit, tabulated in § 1065.602, for the following confidence intervals:

(i) 90% for a proposed alternate procedure for laboratory testing.

(ii) 95% for a proposed alternate procedure for field testing.

(4) Demonstrate the precision of the proposed alternate procedure by showing that it passes an F-test. Use a set of at least seven samples from the reference procedure and a set of at least seven samples from the alternate procedure to perform an F-test. The sets must meet the following requirements:

(i) Within each set, the values must be independent. That is, the probability of any given value in a set must be unchanged by knowledge of another value in that set. For example, your data would violate this requirement if a set showed a distinct increase or decrease that was dependent upon the time at which they were sampled.

(ii) For each set, the population of values from which you sampled must have a normal (i.e., Gaussian) distribution. If the population of values is not normally distributed, consult a statistician for a more appropriate statistical test, which may include transforming the data with a mathematical function or using some kind of non-parametric test.

(iii) The two sets must be independent of each other. That is, the probability of any given value in one set must be unchanged by knowledge of another value in the other set. For example, your data would violate this requirement if one value in a set showed a distinct increase or decrease that was dependent upon a value in the other set. Note that a trend of emission changes from an engine would not violate this requirement.

(iv) If you collect paired data for the paired t-test in paragraph (e)(2) in this section, use caution when selecting sets from paired data for the F-test. If you do this, select sets that do not mask the precision of the measurement procedure. We recommend selecting such sets only from data collected using the same engine, measurement instruments, and test cycle.

(5) Show that F is less than the critical F value, Fcrit, tabulated in § 1065.602. If you have several F-test results from several sets of data, show that the mean F-test value is less than the mean critical F value for all the sets. Evaluate Fcrit, based on the following confidence intervals:

(i) 90% for a proposed alternate procedure for laboratory testing.

(ii) 95% for a proposed alternate procedure for field testing.

[70 FR 40516, July 13, 2005, as amended at 73 FR 37290, June 30, 2008; 79 FR 23752, Apr. 28, 2014; 88 FR 4670, Jan. 24, 2023; 89 FR 29794, Apr. 22, 2024]