§53.4. Applications for reference or equivalent method determinations. — Inbound Citations

Terms used but not defined in this part shall have the meaning given them by the Act.

(c) An applicant who wishes the Administrator to consider revising an appendix to part 50 of this chapter on the ground that the applicant's candidate method is substantially superior to the existing reference method(s) shall submit an application for a reference or equivalent method determination in accordance with § 53.4 and shall indicate therein that such consideration is desired. The application shall include, in addition to the information required by § 53.4, data and any other information supporting the applicant's claim that the candidate method is substantially superior to the existing reference method(s).

(2) If approval of one or more proposed test sites is desired prior to conducting the tests, a written request for approval of the test site or sites must be submitted to the address given in § 53.4. The request should include information identifying the type of candidate method and one or more specific proposed test sites along with a justification for each proposed specific site as described in paragraph (b)(1) of this section. The EPA will evaluate each proposed site and approve the site, disapprove the site, or request more information about the site. Any such pre-test approval of a test site by the EPA shall indicate only that the site meets the applicable test site requirements for the candidate method type; it shall not indicate, suggest, or imply that test data obtained at the site will necessarily meet any of the applicable data acceptance requirements. The Administrator may exercise discretion in selecting a different site (or sites) for any additional tests the Administrator decides to conduct.

(a) A candidate method for PM 2.5 or PM 10-2.5 described in an application for a FRM or FEM determination submitted under § 53.4 shall be determined by the EPA to be a FRM or a Class I, II, or III FEM on the basis of the definitions for such methods given in § 53.1. This subpart sets forth the specific tests that must be carried out and the test results, evidence, documentation, and other materials that must be provided to EPA to demonstrate that a PM 2.5 or PM 10-2.5 sampler associated with a candidate reference method or Class I or Class II equivalent method meets all design and performance specifications set forth in appendix L or O, respectively, of part 50 of this chapter as well as additional requirements specified in this subpart E. Some or all of these tests may also be applicable to a candidate Class III equivalent method or analyzer, as may be determined under § 53.3(b)(3).

(b) A candidate method described in an application for a FRM or FEM determination submitted under § 53.4 shall be determined by the EPA to be a Class II candidate equivalent method on the basis of the definition of a Class II FEM in § 53.1.

(a) An applicant who offers a method for sale as a reference or equivalent method shall report to the EPA Administrator prior to implementation any intended modification of the method, including but not limited to modifications of design or construction or of operational and maintenance procedures specified in the operation manual (see § 53.9(g)). The report shall be signed by an authorized representative of the applicant, marked in accordance with § 53.15 (if applicable), and addressed as specified in § 53.4(a).

(f) Three audit samples must be obtained from the address given in § 53.4(a). For Pb in TSP collected by the high-volume sampling method, the audit samples are 3/4 × 8-inch glass fiber strips containing known amounts of Pb in micrograms per strip (µg/strip) equivalent to the following nominal percentages of the National Ambient Air Quality Standard (NAAQS): 30%, 100%, and 250%. For Pb in PM 10 collected by the low-volume sampling method, the audit samples are 46.2-mm polytetrafluorethylene (PTFE) filters containing known amounts of Pb in micrograms per filter (µg/filter) equivalent to the same percentages of the NAAQS: 30%, 100%, and 250%. The true amount of Pb (Tqi), in total µg/strip (for TSP) or total µg/filter (for PM 10), will be provided for each audit sample.

(1) Hypobaric chamber or other pressure-controlled environment or environments, capable of obtaining and maintaining pressures at 600 mm Hg and 800 mm Hg required for the test with an accuracy of 5 mm Hg. Henceforth, where the test procedures specify a test or environmental chamber, an alternative pressure-controlled environmental area or areas may be substituted, provided the test pressure requirements are met. Means for simulating ambient pressure using a closed-loop sample air system may also be approved for this test; such a proposed method for simulating the test pressure conditions may be described and submitted to EPA at the address given in § 53.4(a) prior to conducting the test for a specific individual determination of acceptability.

(a) of the test analyzer shall be in strict accordance with the operating instructions specified in the manual referred to in § 53.4(b)(3). Allow adequate warm-up or stabilization time as indicated in the operating instructions before beginning the tests. The test procedures assume that the test analyzer has a conventional analog measurement signal output that is connected to a suitable strip chart recorder of the servo, null-balance type. This recorder shall have a chart width of at least 25 centimeters, chart speeds up to 10 cm per hour, a response time of 1 second or less, a deadband of not more than 0.25 percent of full scale, and capability either of reading measurements at least 5 percent below zero or of offsetting the zero by at least 5 percent. If the test analyzer does not have an analog signal output, or if a digital or other type of measurement data output is used for the tests, an alternative measurement data recording device (or devices) may be used for recording the test data, provided that the device is reasonably suited to the nature and purposes of the tests, and an analog representation of the analyzer measurements for each test can be plotted or otherwise generated that is reasonably similar to the analog measurement recordings that would be produced by a conventional chart recorder connected to a conventional analog signal output.

(A) Service or perform the indicated maintenance on the scrubber or prefilter device, as if it were due for such maintenance, as directed in the manual referred to in § 53.4(b)(3).

(1) Once the test analyzer has been set up and calibrated and tests started, manual adjustment or normal periodic maintenance, as specified in the manual referred to in § 53.4(b)(3), is permitted only every 3 days. Automatic adjustments which the test analyzer performs by itself are permitted at any time. The submitted records shall show clearly when manual adjustments were made and describe the operations performed.

(1) For each test campaign, three reference method samplers and three candidate method samplers or analyzers shall be installed and operated concurrently at each test site within each required season (if applicable), as specified in paragraph (b) of this section. All reference method samplers shall be of single-filter design (not multi-filter, sequential sample design). Each candidate method shall be setup and operated in accordance with its associated manual referred to in § 53.4(b)(3) and in accordance with applicable guidance in “Quality Assurance Document 2.12” (reference (2) in appendix A to this subpart). All samplers or analyzers shall be placed so that they sample or measure air representative of the surrounding area (within one kilometer) and are not unduly affected by adjacent buildings, air handling equipment, industrial operations, traffic, or other local influences. The ambient air inlet points of all samplers and analyzers shall be positioned at the same height above the ground level and between 2 meters (1 meter for instruments having sample inlet flow rates less than 200 L/min) and 4 meters apart.

(a) Set-up and start-up of all test samplers shall be in strict accordance with the operating instructions specified in the manual referred to in § 53.4(b)(3).

(i) Set up three identical test samplers at the test site in strict accordance with the instructions in the manual referred to in § 53.4(b)(3). Locate the test sampler inlet openings at the same height and between 2 and 4 meters apart. The samplers shall be oriented in a manner that will minimize spatial and wind directional effects on sample collection. Perform a flow calibration for each test sampler in accordance with the instructions given in the instruction manual and/or appendix J to part 50 of this chapter. Set the operating flow rate to the value prescribed in the sampler instruction manual.

(3) For the purposes of this section, the definitions of ISO 9001-registered facility and ISO-certified auditor are found in § 53.1. An exception to the reliance by EPA on ISO-certified auditors is the requirement for the submission of the operation or instruction manual associated with the candidate method to EPA as part of the application. This manual is required under § 53.4(b)(3). The EPA has determined that acceptable technical judgment for review of this manual may not be assured by ISO-certified auditors, and approval of this manual will therefore be performed by EPA.

(1) The test sampler shall be set up for testing as described in the sampler's operation or instruction manual referred to in § 53.4(b)(3). The sampler shall be installed upright and set up in its normal configuration for collecting PM samples, except that the sample air inlet shall be removed and the flow rate measurement adaptor shall be installed on the sampler's downtube.

(1) Setup of the sampler shall be as required in this paragraph (e) and otherwise as described in the sampler's operation or instruction manual referred to in § 53.4(b)(3). The sampler shall be installed upright and set up in its normal configuration for collecting PM samples. A sample filter and (or) the device for creating an additional 55 mm Hg pressure drop shall be installed for the duration of these tests. The sampler's ambient temperature, ambient pressure, and flow rate measurement systems shall all be calibrated per the sampler's operation or instruction manual within 7 days prior to this test.

(1) Setup of the sampler shall be performed as required in this paragraph (d) and otherwise as described in the sampler's operation or instruction manual referred to in § 53.4(b)(3). The sampler shall be installed upright and set up in its normal configuration for collecting PM samples. A sample filter and (or) the device for creating an additional 55 mm Hg pressure drop shall be installed for the duration of these tests. The sampler's ambient temperature, ambient pressure, and flow measurement systems shall all be calibrated per the sampler's operating manual within 7 days prior to this test.

(1) Setup of the sampler shall be performed as required in this paragraph (e) and otherwise as described in the sampler's operation or instruction manual referred to in § 53.4(b)(3). The sampler shall be installed upright and set up in the temperature-controlled chamber in its normal configuration for collecting PM samples. A sample filter and (or) the device for creating an additional 55 mm Hg pressure drop shall be installed for the duration of these tests. The sampler's ambient temperature, ambient pressure, and flow measurement systems shall all be calibrated per the sampler's operating manual within 7 days prior to this test.

(1) Setup of the sampler shall be performed as required in this paragraph (e) and otherwise as described in the sampler's operation or instruction manual referred to in § 53.4(b)(3). The sampler shall be installed upright and set up in the pressure-controlled chamber in its normal configuration for collecting PM samples. A sample filter and (or) the device for creating an additional 55 mm Hg pressure drop shall be installed for the duration of these tests. The sampler's ambient temperature, ambient pressure, and flow measurement systems shall all be calibrated per the sampler's operating manual within 7 days prior to this test.

(1) Setup of the sampler shall be performed as required in this paragraph (e) and otherwise as described in the sampler's operation or instruction manual referred to in § 53.4(b)(3). The sampler shall be installed upright and set up in the solar radiation environmental chamber in its normal configuration for collecting PM samples (with the inlet installed). The sampler's ambient and filter temperature measurement systems shall be calibrated per the sampler's operating manual within 7 days prior to this test. A sample filter shall be installed for the duration of this test. For sequential samplers, a sample filter shall also be installed in each available sequential channel or station intended for collection of a sequential sample (or at least five additional filters for magazine-type sequential samplers) as directed by the sampler's operation or instruction manual.

(1) Three identical test samplers shall be installed at the test site in their normal configuration for collecting PM samples in accordance with the instructions in the associated manual referred to in § 53.4(b)(3) and also in accordance with applicable supplemental guidance provided in reference 3 in appendix A of this subpart. The test samplers' inlet openings shall be located at the same height above ground and between 2 (1 for samplers with flow rates less than 200 L/min.) and 4 meters apart horizontally. The samplers shall be arranged or oriented in a manner that will minimize the spatial and wind directional effects on sample collection of one sampler on any other sampler.

(a) Any method offered for sale as a FRM or FEM shall be accompanied by a copy of the manual referred to in § 53.4(b)(3) when delivered to any ultimate purchaser, and an electronic copy of the manual suitable for incorporating into user-specific standard operating procedure documents shall be readily available to any users.