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§53.1 Definitions.
Terms used but not defined in this part shall have the meaning given them by the Act.
Act means the Clean Air Act (42 U.S.C. 1857-1857l), as amended.
Additive and multiplicative bias means the linear regression intercept and slope of a linear plot fitted to corresponding candidate and reference method mean measurement data pairs.
Administrator means the Administrator of the Environmental Protection Agency (EPA) or his or her authorized representative.
Agency means the Environmental Protection Agency.
Applicant means a person or entity who submits an application for a Federal reference method or Federal equivalent method determination under §53.4, or a person or entity who assumes the rights and obligations of an applicant under §53.7. Applicant may include a manufacturer, distributor, supplier, or vendor.
Automated method or analyzer means a method for measuring concentrations of an ambient air pollutant in which sample collection (if necessary), analysis, and measurement are performed automatically by an instrument.
Candidate method means a method for measuring the concentration of an air pollutant in the ambient air for which an application for a Federal reference method determination or a Federal equivalent method determination is submitted in accordance with §53.4, or a method tested at the initiative of the Administrator in accordance with §53.7.
Class I equivalent method means an equivalent method for PM 2.5 or PM 10-2.5 which is based on a sampler that is very similar to the sampler specified for reference methods in appendix L or appendix O (as applicable) of part 50 of this chapter, with only minor deviations or modifications, as determined by EPA.
Class II equivalent method means an equivalent method for PM 2.5 or PM 10-2.5 that utilizes a PM 2.5 sampler or PM 10-2.5 sampler in which integrated PM 2.5 samples or PM 10-2.5 samples are obtained from the atmosphere by filtration and subjected to a subsequent filter conditioning process followed by a gravimetric mass determination, but which is not a Class I equivalent method because of substantial deviations from the design specifications of the sampler specified for reference methods in appendix L or appendix O (as applicable) of part 50 of this chapter, as determined by EPA.
Class III equivalent method means an equivalent method for PM 2.5 or PM 10-2.5 that is an analyzer capable of providing PM 2.5 or PM 10-2.5 ambient air measurements representative of one-hour or less integrated PM 2.5 or PM 10-2.5 concentrations as well as 24-hour measurements determined as, or equivalent to, the mean of 24 one-hour consecutive measurements.
CO means carbon monoxide.
Collocated means two or more air samplers, analyzers, or other instruments that are operated simultaneously while located side by side, separated by a distance that is large enough to preclude the air sampled by any of the devices from being affected by any of the other devices, but small enough so that all devices obtain identical or uniform ambient air samples that are equally representative of the general area in which the group of devices is located.
Federal equivalent method (FEM) means a method for measuring the concentration of an air pollutant in the ambient air that has been designated as an equivalent method in accordance with this part; it does not include a method for which an equivalent method designation has been canceled in accordance with §53.11 or §53.16.
Federal reference method (FRM) means a method of sampling and analyzing the ambient air for an air pollutant that is specified as a reference method in an appendix to part 50 of this chapter, or a method that has been designated as a reference method in accordance with this part; it does not include a method for which a reference method designation has been canceled in accordance with §53.11 or §53.16.
ISO 9001-registered facility means a manufacturing facility that is either:
(1) An International Organization for Standardization (ISO) 9001-registered manufacturing facility, registered to the ISO 9001 standard (by the Registrar Accreditation Board (RAB) of the American Society for Quality Control (ASQC) in the United States), with registration maintained continuously; or
(2) A facility that can be demonstrated, on the basis of information submitted to the EPA, to be operated according to an EPA-approved and periodically audited quality system which meets, to the extent appropriate, the same general requirements as an ISO 9001-registered facility for the design and manufacture of designated Federal reference method and Federal equivalent method samplers and monitors.
ISO-certified auditor means an auditor who is either certified by the Registrar Accreditation Board (in the United States) as being qualified to audit quality systems using the requirements of recognized standards such as ISO 9001, or who, based on information submitted to the EPA, meets the same general requirements as provided for ISO-certified auditors.
Manual method means a method for measuring concentrations of an ambient air pollutant in which sample collection, analysis, or measurement, or some combination thereof, is performed manually. A method for PM 10 or PM 2.5 which utilizes a sampler that requires manual preparation, loading, and weighing of filter samples is considered a manual method even though the sampler may be capable of automatically collecting a series of sequential samples.
NO means nitrogen oxide.
NO2 means nitrogen dioxide.
NOX means oxides of nitrogen and is defined as the sum of the concentrations of NO2 and NO.
O3 means ozone.
Operated simultaneously means that two or more collocated samplers or analyzers are operated concurrently with no significant difference in the start time, stop time, and duration of the sampling or measurement period.
Pb means lead.
PM means PM 10, PM 10C, PM 2.5, PM 10-2.5, or particulate matter of unspecified size range.
PM2.5 means particulate matter with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers as measured by a reference method based on appendix L of part 50 of this chapter and designated in accordance with part 53 of this chapter, by an equivalent method designated in accordance with part 53 of this chapter, or by an approved regional method designated in accordance with appendix C to this part.
PM10 means particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers as measured by a reference method based on appendix J of part 50 of this chapter and designated in accordance with this part or by an equivalent method designated in accordance with this part.
PM10C means particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers as measured by a reference method based on appendix O of part 50 of this chapter and designated in accordance with this part or by an equivalent method designated in accordance with this part.
PM10-2.5 means particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers and greater than a nominal 2.5 micrometers as measured by a reference method based on appendix O to part 50 of this chapter and designated in accordance with this part or by an equivalent method designated in accordance with this part.
PM2.5sampler means a device, associated with a manual method for measuring PM 2.5, designed to collect PM 2.5 from an ambient air sample, but lacking the ability to automatically analyze or measure the collected sample to determine the mass concentrations of PM 2.5 in the sampled air.
PM10sampler means a device, associated with a manual method for measuring PM 10, designed to collect PM 10 from an ambient air sample, but lacking the ability to automatically analyze or measure the collected sample to determine the mass concentrations of PM 10 in the sampled air.
PM10Csampler means a PM 10 sampler that meets the special requirements for a PM 10C sampler that is part of a PM 10-2.5 reference method sampler, as specified in appendix O to part 50 of this chapter, or a PM 10 sampler that is part of a PM 10-2.5 sampler that has been designated as an equivalent method for PM 10-2.5.
PM10-2.5sampler means a sampler, or a collocated pair of samplers, associated with a manual method for measuring PM 10-2.5 and designed to collect either PM 10-2.5 directly or PM 10C and PM 2.5 separately and simultaneously from concurrent ambient air samples, but lacking the ability to automatically analyze or measure the collected sample(s) to determine the mass concentrations of PM 10-2.5 in the sampled air.
Sequential samples for PM samplers means two or more PM samples for sequential (but not necessarily contiguous) time periods that are collected automatically by the same sampler without the need for intervening operator service.
SO2 means sulfur dioxide.
Test analyzer means an analyzer subjected to testing as part of a candidate method in accordance with subparts B, C, D, E, or F of this part, as applicable.
Test sampler means a PM 10 sampler, PM 2.5 sampler, or PM 10-2.5 sampler subjected to testing as part of a candidate method in accordance with subparts C, D, E, or F of this part.
Ultimate purchaser means the first person or entity who purchases a Federal reference method or a Federal equivalent method for purposes other than resale.
[71 FR 61271, Oct. 17, 2006]
§53.2 General requirements for a reference method determination.
The following general requirements for a Federal reference method (FRM) determination are summarized in table A-1 of this subpart.
(a) Manual methods - (1) Sulfur dioxide (SO2) and Lead. For measuring SO2 and lead, appendixes A-2 and G of part 50 of this chapter specify unique manual FRM for measuring those pollutants. Except as provided in §53.16, other manual methods for lead will not be considered for a reference method determination under this part.
(2) PM10. A FRM for measuring PM 10 must be a manual method that meets all rcequirements specified in appendix J of part 50 of this chapter and must include a PM 10 sampler that has been shown in accordance with this part to meet all requirements specified in this Subpart A and Subpart D of this part.
(3) PM2.5. A FRM for measuring PM 2.5 must be a manual method that meets all requirements specified in appendix L of part 50 of this chapter and must include a PM 2.5 sampler that has been shown in accordance with this part to meet the applicable requirements specified in this Subpart A and Subpart E of this part. Further, FRM samplers must be manufactured in an ISO 9001-registered facility, as defined in §53.1 and as set forth in §53.51.
(4) PM10-2.5. A FRM for measuring PM 10-2.5 must be a manual method that meets all requirements specified in appendix O of part 50 of this chapter and must include PM 10C and PM 2.5 samplers that have been shown in accordance with this part to meet the applicable requirements specified in this Subpart A and Subpart E of this part. Further, PM 10-2.5 FRM samplers must be manufactured in an ISO 9001-registered facility, as defined in §53.1 and as set forth in §53.51.
(b) Automated methods. An automated FRM for measuring SO2, CO, O3, or NO2 must utilize the measurement principle and calibration procedure specified in the appropriate appendix to part 50 of this chapter (appendix A-1 only for SO2 methods) and must have been shown in accordance with this part to meet the requirements specified in this subpart A and subpart B of this part.
[71 FR 61271, Oct. 17, 2006, as amended at 75 FR 35597, June 22, 2010]
§53.3 General requirements for an equivalent method determination.
(a) Manual methods. A manual Federal equivalent method (FEM) must have been shown in accordance with this part to satisfy the applicable requirements specified in this Subpart A and Subpart C of this part. In addition, a PM sampler associated with a manual method for PM 10, PM 2.5, or PM 10-2.5 must have been shown in accordance with this part to satisfy the following additional requirements, as applicable:
(1) PM10. A PM 10 sampler associated with a manual method for PM 10 must satisfy the requirements of Subpart D of this part.
(2) PM2.5Class I. A PM 2.5 Class I FEM sampler must also satisfy all requirements of Subpart E of this part, which shall include appropriate demonstration that each and every deviation or modification from the FRM sampler specifications does not significantly alter the performance of the sampler.
(3) PM2.5Class II. (i) A PM 2.5 Class II FEM sampler must also satisfy the applicable requirements of subparts E and F of this part or the alternative requirements in paragraph (a)(3)(ii) of this section.
(ii) In lieu of the applicable requirements specified for Class II PM 2.5 methods in subparts C and F of this part, a Class II PM 2.5 FEM sampler may alternatively meet the applicable requirements in paragraphs (b)(3)(i) through (iii) of this section and the testing, performance, and comparability requirements specified for Class III equivalent methods for PM 2.5 in Subpart C of this part.
(4) PM10-2.5Class I. A PM 10-2.5 Class I FEM sampler must also satisfy the applicable requirements of Subpart E of this part (there are no additional requirements specifically for Class I PM 10-2.5 methods in Subpart C of this part).
(5) PM10-2.5Class II. (i) A PM 10-2.5 Class II FEM sampler must also satisfy the applicable requirements of Subpart C of this part and also the applicable requirements and provisions of paragraphs (b)(3)(i) through (iii) of this section, or the alternative requirements in paragraph (a)(5)(ii) of this section.
(ii) In lieu of the applicable requirements specified for Class II PM 10-2.5 methods in Subpart C of this part and in paragraph (b)(3)(iii) of this section, a Class II PM 10-2.5 FEM sampler may alternatively meet the applicable requirements in paragraphs (b)(3)(i) and (ii) of this section and the testing, performance, and comparability requirements specified for Class III FEMs for PM 10-2.5 in Subpart C of this part.
(6) ISO 9001. All designated FEMs for PM 2.5 or PM 10-2.5 must be manufactured in an ISO 9001-registered facility, as defined in §53.1 and as set forth in §53.51.
(b) Automated methods. All types of automated FEMs must have been shown in accordance with this part to satisfy the applicable requirements specified in this Subpart A and Subpart C of this part. In addition, an automated FEM must have been shown in accordance with this part to satisfy the following additional requirements, as applicable:
(1) An automated FEM for pollutants other than PM must be shown in accordance with this part to satisfy the applicable requirements specified in Subpart B of this part.
(2) An automated FEM for PM 10 must be shown in accordance with this part to satisfy the applicable requirements of Subpart D of this part.
(3) A Class III automated FEM for PM 2.5 or PM 10-2.5 must be shown in accordance with this part to satisfy the requirements in paragraphs (b)(3)(i) through (iii) of this section, as applicable.
(i) All pertinent requirements of 40 CFR part 50, appendix L, including sampling height, range of operational conditions, ambient temperature and pressure sensors, outdoor enclosure, electrical power supply, control devices and operator interfaces, data output port, operation/instruction manual, data output and reporting requirements, and any other requirements that would be reasonably applicable to the method, unless adequate (as determined by the Administrator) rationale can be provided to support the contention that a particular requirement does not or should not be applicable to the particular candidate method.
(ii) All pertinent tests and requirements of Subpart E of this part, such as instrument manufacturing quality control; final assembly and inspection; manufacturer's audit checklists; leak checks; flow rate accuracy, measurement accuracy, and flow rate cut-off; operation following power interruptions; effect of variations in power line voltage, ambient temperature and ambient pressure; and aerosol transport; unless adequate (as determined by the Administrator) rationale can be provided to support the contention that a particular test or requirement does not or should not be applicable to the particular candidate method.
(iii) Candidate methods shall be tested for and meet any performance requirements, such as inlet aspiration, particle size separation or selection characteristics, change in particle separation or selection characteristics due to loading or other operational conditions, or effects of surface exposure and particle volatility, determined by the Administrator to be necessary based on the nature, design, and specifics of the candidate method and the extent to which it deviates from the design and performance characteristics of the reference method. These performance requirements and the specific test(s) for them will be determined by Administrator for each specific candidate method or type of candidate method and may be similar to or based on corresponding tests and requirements set forth in Subpart F of this part or may be special requirements and tests tailored by the Administrator to the specific nature, design, and operational characteristics of the candidate method. For example, a candidate method with an inlet design deviating substantially from the design of the reference method inlet would likely be subject to an inlet aspiration test similar to that set forth in §53.63. Similarly, a candidate method having an inertial fractionation system substantially different from that of the reference method would likely be subject to a static fractionation test and a loading test similar to those set forth in §§53.64 and 53.65, respectively. A candidate method with more extensive or profound deviations from the design and function of the reference method may be subject to other tests, full wind-tunnel tests similar to those described in §53.62, or to special tests adapted or developed individually to accommodate the specific type of measurement or operation of the candidate method.
(4) All designated FEM for PM 2.5 or PM 10-2.5 must be manufactured in an ISO 9001-registered facility, as defined in §53.1 and as set forth in §53.51.
[71 FR 61271, Oct. 17, 2006]
§53.4 Applications for reference or equivalent method determinations.
(a) Applications for FRM or FEM determinations and modification requests of existing designated instruments shall be submitted to: U.S. Environmental Protection Agency, Director, Center for Environmental Measurement and Modeling, Reference and Equivalent Methods Designation Program (MD–D205–03), 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711 (commercial delivery address: 4930 Old Page Road, Durham, North Carolina 27703).
(b) Each application shall be signed by an authorized representative of the applicant, shall be marked in accordance with §53.15 (if applicable), and shall contain the following:
(1) A clear identification of the candidate method, which will distinguish it from all other methods such that the method may be referred to unambiguously. This identification must consist of a unique series of descriptors such as title, identification number, analyte, measurement principle, manufacturer, brand, model, etc., as necessary to distinguish the method from all other methods or method variations, both within and outside the applicant's organization.
(2) A detailed description of the candidate method, including but not limited to the following: The measurement principle, manufacturer, name, model number and other forms of identification, a list of the significant components, schematic diagrams, design drawings, and a detailed description of the apparatus and measurement procedures. Drawings and descriptions pertaining to candidate methods or samplers for PM 2.5 or PM 10-2.5 must meet all applicable requirements in reference 1 of appendix A of this subpart, using appropriate graphical, nomenclature, and mathematical conventions such as those specified in references 3 and 4 of appendix A of this subpart.
(3) A copy of a comprehensive operation or instruction manual providing a complete and detailed description of the operational, maintenance, and calibration procedures prescribed for field use of the candidate method and all instruments utilized as part of that method (under §53.9(a)).
(i) As a minimum this manual shall include:
(A) Description of the method and associated instruments.
(B) Explanation of all indicators, information displays, and controls.
(C) Complete setup and installation instructions, including any additional materials or supplies required.
(D) Details of all initial or startup checks or acceptance tests and any auxiliary equipment required.
(E) Complete operational instructions.
(F) Calibration procedures and descriptions of required calibration equipment and standards.
(G) Instructions for verification of correct or proper operation.
(H) Trouble-shooting guidance and suggested corrective actions for abnormal operation.
(I) Required or recommended routine, periodic, and preventative maintenance and maintenance schedules.
(J) Any calculations required to derive final concentration measurements.
(K) Appropriate references to any applicable appendix of part 50 of this chapter; reference 6 of appendix A of this subpart; and any other pertinent guidelines.
(ii) The manual shall also include adequate warning of potential safety hazards that may result from normal use and/or malfunction of the method and a description of necessary safety precautions. (See §53.9(b).) However, the previous requirement shall not be interpreted to constitute or imply any warranty of safety of the method by EPA. For samplers and automated methods, the manual shall include a clear description of all procedures pertaining to installation, operation, preventive maintenance, and troubleshooting and shall also include parts identification diagrams. The manual may be used to satisfy the requirements of paragraphs (b)(1) and (2) of this section to the extent that it includes information necessary to meet those requirements.
(4) A statement that the candidate method has been tested in accordance with the procedures described in subparts B, C, D, E, and/or F of this part, as applicable.
(5) Descriptions of test facilities and test configurations, test data, records, calculations, and test results as specified in subparts B, C, D, E, and/or F of this part, as applicable. Data must be sufficiently detailed to meet appropriate principles described in part B, sections 3.3.1 (paragraph 1) and 3.5.1 and part C, section 4.6 of reference 2 of appendix A of this subpart; and in paragraphs 1 through 3 of section 4.8 (Records) of reference 5 of appendix A of this subpart. Salient requirements from these references include the following:
(i) The applicant shall maintain and include records of all relevant measuring equipment, including the make, type, and serial number or other identification, and most recent calibration with identification of the measurement standard or standards used and their National Institute of Standards and Technology (NIST) traceability. These records shall demonstrate the measurement capability of each item of measuring equipment used for the application and include a description and justification (if needed) of the measurement setup or configuration in which it was used for the tests. The calibration results shall be recorded and identified in sufficient detail so that the traceability of all measurements can be determined and any measurement could be reproduced under conditions close to the original conditions, if necessary, to resolve any anomalies.
(ii) Test data shall be collected according to the standards of good practice and by qualified personnel. Test anomalies or irregularities shall be documented and explained or justified. The impact and significance of the deviation on test results and conclusions shall be determined. Data collected shall correspond directly to the specified test requirement and be labeled and identified clearly so that results can be verified and evaluated against the test requirement. Calculations or data manipulations must be explained in detail so that they can be verified.
(6) A statement that the method, analyzer, or sampler tested in accordance with this part is representative of the candidate method described in the application.
(7) All written materials for new FRM and FEM applications and modification requests must be submitted in English in MS Word format. For any calibration certificates originally written in a non-English language, the original non-English version of the certificate must be submitted to EPA along with a version of the certificate translated to English. All laboratory and field data associated with new FRM and FEM applications and modification requests must be submitted in MS Excel format. All worksheets in MS Excel must be unprotected to enable full inspection as part of the application review process.
(c) For candidate automated methods and candidate manual methods for PM 10, PM 2.5, and PM 10-2.5 the application shall also contain the following:
(1) A detailed description of the quality system that will be utilized, if the candidate method is designated as a reference or equivalent method, to ensure that all analyzers or samplers offered for sale under that designation will have essentially the same performance characteristics as the analyzer(s) or samplers tested in accordance with this part. In addition, the quality system requirements for candidate methods for PM 2.5 and PM 10-2.5 must be described in sufficient detail, based on the elements described in section 4 of reference 1 (Quality System Requirements) of appendix A of this subpart. Further clarification is provided in the following sections of reference 2 of appendix A of this subpart: part A (Management Systems), sections 2.2 (Quality System and Description), 2.3 (Personnel Qualification and Training), 2.4 (Procurement of Items and Services), 2.5 (Documents and Records), and 2.7 (Planning); part B (Collection and Evaluation of Environmental Data), sections 3.1 (Planning and Scoping), 3.2 (Design of Data Collection Operations), and 3.5 (Assessment and Verification of Data Usability); and part C (Operation of Environmental Technology), sections 4.1 (Planning), 4.2 (Design of Systems), and 4.4 (Operation of Systems).
(2) A description of the durability characteristics of such analyzers or samplers (see §53.9(c)). For methods for PM 2.5 and PM 10-2.5 the warranty program must ensure that the required specifications (see Table A-1 to this subpart) will be met throughout the warranty period and that the applicant accepts responsibility and liability for ensuring this conformance or for resolving any nonconformities, including all necessary components of the system, regardless of the original manufacturer. The warranty program must be described in sufficient detail to meet appropriate provisions of the ANSI/ASQC and ISO 9001 standards (references 1 and 2 in appendix A of this subpart) for controlling conformance and resolving nonconformance, particularly sections 4.12, 4.13, and 4.14 of reference 1 in appendix A of this subpart.
(i) Section 4.12 in reference 1 of appendix A of this subpart requires the manufacturer to establish and maintain a system of procedures for identifying and maintaining the identification of inspection and test status throughout all phases of manufacturing to ensure that only instruments that have passed the required inspections and tests are released for sale.
(ii) Section 4.13 in reference 1 of appendix A of this subpart requires documented procedures for control of nonconforming product, including review and acceptable alternatives for disposition; section 4.14 in reference 1 of appendix A of this subpart requires documented procedures for implementing corrective (4.14.2) and preventive (4.14.3) action to eliminate the causes of actual or potential nonconformities. In particular, section 4.14.3 requires that potential causes of nonconformities be eliminated by using information such as service reports and customer complaints to eliminate potential causes of nonconformities.
(d) For candidate reference or equivalent methods or for designated instruments that are the subject of a modification request, the applicant, if requested by EPA, shall provide to EPA a representative sampler or analyzer for test purposes. The sampler or analyzer shall be shipped free on board (FOB) destination to Director, Center for Environmental Measurements and Modeling, Reference and Equivalent Methods Designation Program (MD D205–03), U.S. Environmental Protection Agency, 4930 Old Page Road, Durham, North Carolina 27703, scheduled to arrive concurrently with or within 30 days of the arrival of the other application materials. This sampler or analyzer may be subjected to various tests that EPA determines to be necessary or appropriate under §53.5(f), and such tests may include special tests not described in this part. If the instrument submitted under this paragraph (d) malfunctions, becomes inoperative, or fails to perform as represented in the application before the necessary EPA testing is completed, the applicant shall be afforded the opportunity to repair or replace the device at no cost to the EPA. Upon completion of EPA testing, the sampler or analyzer submitted under this paragraph (d) shall be repacked by EPA for return shipment to the applicant, using the same packing materials used for shipping the instrument to EPA unless alternative packing is provided by the applicant. Arrangements for, and the cost of, return shipment shall be the responsibility of the applicant. The EPA does not warrant or assume any liability for the condition of the sampler or analyzer upon return to the applicant.
[71 FR 61271, Oct. 17, 2006; 89 FR 16382, March 6, 2024]
§53.5 Processing of applications.
After receiving an application for a FRM or FEM determination, the Administrator will, within 120 calendar days after receipt of the application, take one or more of the following actions:
(a) Send notice to the applicant, in accordance with §53.8, that the candidate method has been determined to be a reference or equivalent method.
(b) Send notice to the applicant that the application has been rejected, including a statement of reasons for rejection.
(c) Send notice to the applicant that additional information must be submitted before a determination can be made and specify the additional information that is needed (in such cases, the 120-day period shall commence upon receipt of the additional information).
(d) Send notice to the applicant that additional test data must be submitted and specify what tests are necessary and how the tests shall be interpreted (in such cases, the 120-day period shall commence upon receipt of the additional test data).
(e) Send notice to the applicant that the application has been found to be substantially deficient or incomplete and cannot be processed until additional information is submitted to complete the application and specify the general areas of substantial deficiency.
(f) Send notice to the applicant that additional tests will be conducted by the Administrator, specifying the nature of and reasons for the additional tests and the estimated time required (in such cases, the 120-day period shall commence 1 calendar day after the additional tests have been completed).
[71 FR 61271, Oct. 17, 2006]
§53.6 Right to witness conduct of tests.
(a) Submission of an application for a reference or equivalent method determination shall constitute consent for the Administrator or the Administrator's authorized representative, upon presentation of appropriate credentials, to witness or observe any tests required by this part in connection with the application or in connection with any modification or intended modification of the method by the applicant.
(b) The applicant shall have the right to witness or observe any test conducted by the Administrator in connection with the application or in connection with any modification or intended modification of the method by the applicant.
(c) Any tests by either party that are to be witnessed or observed by the other party shall be conducted at a time and place mutually agreeable to both parties.
§53.7 Testing of methods at the initiative of the Administrator.
(a) In the absence of an application for a reference or equivalent method determination, the Administrator may conduct the tests required by this part for such a determination, may compile such other information as may be necessary in the judgment of the Administrator to make such a determination, and on the basis of the tests and information may determine that a method satisfies applicable requirements of this part.
(b) In the absence of an application requesting the Administrator to consider revising an appendix to part 50 of this chapter in accordance with §53.16, the Administrator may conduct such tests and compile such information as may be necessary in the Administrator's judgment to make a determination under §53.16(d) and on the basis of the tests and information make such a determination.
(c) If a method tested in accordance with this section is designated as a reference or equivalent method in accordance with §53.8 or is specified or designated as a reference method in accordance with §53.16, any person or entity who offers the method for sale as a reference or equivalent method thereafter shall assume the rights and obligations of an applicant for purposes of this part, with the exception of those pertaining to submission and processing of applications.
§53.8 Designation of reference and equivalent methods.
(a) A candidate method determined by the Administrator to satisfy the applicable requirements of this part shall be designated as an FRM or FEM (as applicable) by and upon publication of the designation in the Federal Register . Applicants shall not publicly announce, market, or sell the candidate sampler and analyzer as an approved FRM or FEM (as applicable) until the designation is published in the Federal Register.
(b) Upon designation, a notice indicating that the method has been designated as a FRM or FEM shall be sent to the applicant.
(c) The Administrator will maintain a current list of methods designated as FRM or FEM in accordance with this part and will send a copy of the list to any person or group upon request. A copy of the list will be available via the Internet and may be available from other sources.
[71 FR 61276, Oct. 17, 2006, as amended at 75 FR 35597, June 22, 2010; 89 FR 16382, March 6, 2024]
§53.9 Conditions of designation.
Designation of a candidate method as a FRM or FEM shall be conditioned to the applicant's compliance with the following requirements. Failure to comply with any of the requirements shall constitute a ground for cancellation of the designation in accordance with §53.11.
(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.
(b) Any method offered for sale as a FRM or FEM shall generate no unreasonable hazard to operators or to the environment during normal use or when malfunctioning.
(c) Any analyzer, PM 10 sampler, PM 2.5 sampler, or PM 10-2.5 sampler offered for sale as part of an FRM or FEM shall function within the limits of the performance specifications referred to in §53.20(a), §53.30(a), §53.35, §53.50, or §53.60, as applicable, for at least 1 year after delivery and acceptance when maintained and operated in accordance with the manual referred to in §53.4(b)(3).
(d) Any analyzer, PM 10 sampler, PM 2.5 sampler, or PM 10-2.5 sampler offered for sale as a FRM or FEM shall bear a prominent, permanently affixed label or sticker indicating that the analyzer or sampler has been designated by EPA as a FRM or FEM (as applicable) in accordance with this part and displaying any designated method identification number that may be assigned by EPA.
(e) If an analyzer is offered for sale as a FRM or FEM and has one or more selectable ranges, the label or sticker required by paragraph (d) of this section shall be placed in close proximity to the range selector and shall indicate clearly which range or ranges have been designated as parts of the FRM or FEM.
(f) An applicant who offers analyzers, PM 10 samplers, PM 2.5 samplers, or PM 10-2.5 samplers for sale as FRM or FEMs shall maintain an accurate and current list of the names and mailing addresses of all ultimate purchasers of such analyzers or samplers. For a period of 7 years after publication of the FRM or FEM designation applicable to such an analyzer or sampler, the applicant shall notify all ultimate purchasers of the analyzer or sampler within 30 days if the designation has been canceled in accordance with §53.11 or §53.16 or if adjustment of the analyzer or sampler is necessary under §53.11(b).
(g) If an applicant modifies an analyzer, PM 10 sampler, PM 2.5 sampler, or PM 10-2.5 sampler that has been designated as a FRM or FEM, the applicant shall not sell the modified analyzer or sampler as a reference or equivalent method nor attach a label or sticker to the modified analyzer or sampler under paragraph (d) or (e) of this section until the applicant has received notice under §53.14(c) that the existing designation or a new designation will apply to the modified analyzer or sampler or has applied for and received notice under §53.8(b) of a new FRM or FEM determination for the modified analyzer or sampler.
(h) An applicant who has offered PM 2.5 or PM 10-2.5 samplers or analyzers for sale as part of a FRM or FEM may continue to do so only so long as the facility in which the samplers or analyzers are manufactured continues to be an ISO 9001-registered facility, as set forth in Subpart E of this part. In the event that the ISO 9001 registration for the facility is withdrawn, suspended, or otherwise becomes inapplicable, either permanently or for some specified time interval, such that the facility is no longer an ISO 9001-registered facility, the applicant shall notify EPA within 30 days of the date the facility becomes other than an ISO 9001-registered facility, and upon such notification, EPA shall issue a preliminary finding and notification of possible cancellation of the FRM or FEM designation under §53.11.
[71 FR 61276, Oct. 17, 2006, as amended at 78 FR 3281, Jan. 15, 2013; 80 FR 65460, Oct. 26, 2015]
§53.10 Appeal from rejection of application.
Any applicant whose application for a reference or equivalent method determination has been rejected may appeal the Administrator's decision by taking one or more of the following actions:
(a) The applicant may submit new or additional information in support of the application.
(b) The applicant may request that the Administrator reconsider the data and information already submitted.
(c) The applicant may request that any test conducted by the Administrator that was a material factor in the decision to reject the application be repeated.
§53.11 Cancellation of reference or equivalent method designation.
(a) Preliminary finding. If the Administrator makes a preliminary finding on the basis of any available information that a representative sample of a method designated as a reference or equivalent method and offered for sale as such does not fully satisfy the requirements of this part or that there is any violation of the requirements set forth in §53.9, the Administrator may initiate proceedings to cancel the designation in accordance with the following procedures.
(b) Notification and opportunity to demonstrate or achieve compliance. (1) After making a preliminary finding in accordance with paragraph (a) of this section, the Administrator will send notice of the preliminary finding to the applicant, together with a statement of the facts and reasons on which the preliminary finding is based, and will publish notice of the preliminary finding in the Federal Register.
(2) The applicant will be afforded an opportunity to demonstrate or to achieve compliance with the requirements of this part within 60 days after publication of notice in accordance with paragraph (b)(1) of this section or within such further period as the Administrator may allow, by demonstrating to the satisfaction of the Administrator that the method in question satisfies the requirements of this part, by commencing a program to make any adjustments that are necessary to bring the method into compliance, or by taking such action as may be necessary to cure any violation of the requirements of §53.9. If adjustments are necessary to bring the method into compliance, all such adjustments shall be made within a reasonable time as determined by the Administrator. If the applicant demonstrates or achieves compliance in accordance with this paragraph (b)(2), the Administrator will publish notice of such demonstration or achievement in the Federal Register.
(c) Request for hearing. Within 60 days after publication of a notice in accordance with paragraph (b)(1) of this section, the applicant or any interested person may request a hearing as provided in §53.12.
(d) Notice of cancellation. If, at the end of the period referred to in paragraph (b)(2) of this section, the Administrator determines that the reference or equivalent method designation should be canceled, a notice of cancellation will be published in the Federal Register and the designation will be deleted from the list maintained under §53.8(c). If a hearing has been requested and granted in accordance with §53.12, action under this paragraph (d) will be taken only after completion of proceedings (including any administrative review) conducted in accordance with §53.13 and only if the decision of the Administrator reached in such proceedings is that the designation in question should be canceled.
§53.12 Request for hearing on cancellation.
Within 60 days after publication of a notice in accordance with §53.11(b)(1), the applicant or any interested person may request a hearing on the Administrator's action. If, after reviewing the request and supporting data, the Administrator finds that the request raises a substantial issue of fact, a hearing will be granted in accordance with §53.13 with respect to such issue. The request shall be in writing, signed by an authorized representative of the applicant or interested person, and shall include a statement specifying:
(a) Any objections to the Administrator's action.
(b) Data or other information in support of such objections.
§53.13 Hearings.
(a)(1) After granting a request for a hearing under §53.12, the Administrator will designate a presiding officer for the hearing.
(2) If a time and place for the hearing have not been fixed by the Administrator, the hearing will be held as soon as practicable at a time and place fixed by the presiding officer, except that the hearing shall in no case be held sooner than 30 days after publication of a notice of hearing in the Federal Register.
(3) For purposes of the hearing, the parties shall include EPA, the applicant or interested person(s) who requested the hearing, and any person permitted to intervene in accordance with paragraph (c) of this section.
(4) The Deputy General Counsel or the Deputy General Counsel's representative will represent EPA in any hearing under this section.
(5) Each party other than EPA may be represented by counsel or by any other duly authorized representative.
(b)(1) Upon appointment, the presiding officer will establish a hearing file. The file shall contain copies of the notices issued by the Administrator pursuant to §53.11(b)(1), together with any accompanying material, the request for a hearing and supporting data submitted therewith, the notice of hearing published in accordance with paragraph (a)(2) of this section, and correspondence and other material data relevant to the hearing.
(2) The hearing file shall be available for inspection by the parties or their representatives at the office of the presiding officer, except to the extent that it contains information identified in accordance with §53.15.
(c) The presiding officer may permit any interested person to intervene in the hearing upon such a showing of interest as the presiding officer may require; provided that permission to intervene may be denied in the interest of expediting the hearing where it appears that the interests of the person seeking to intervene will be adequately represented by another party (or by other parties), including EPA.
(d)(1) The presiding officer, upon the request of any party or at the officer's discretion, may arrange for a prehearing conference at a time and place specified by the officer to consider the following:
(i) Simplification of the issues.
(ii) Stipulations, admissions of fact, and the introduction of documents.
(iii) Limitation of the number of expert witnesses.
(iv) Possibility of agreement on disposing of all or any of the issues in dispute.
(v) Such other matters as may aid in the disposition of the hearing, including such additional tests as may be agreed upon by the parties.
(2) The results of the conference shall be reduced to writing by the presiding officer and made part of the record.
(e)(1) Hearings shall be conducted by the presiding officer in an informal but orderly and expeditious manner. The parties may offer oral or written evidence, subject to exclusion by the presiding officer of irrelevant, immaterial, or repetitious evidence.
(2) Witnesses shall be placed under oath.
(3) Any witness may be examined or cross-examined by the presiding officer, the parties, or their representatives. The presiding officer may, at his/her discretion, limit cross-examination to relevant and material issues.
(4) Hearings shall be reported verbatim. Copies of transcripts of proceedings may be purchased from the reporter.
(5) All written statements, charts, tabulations, and data offered in evidence at the hearing shall, upon a showing satisfactory to the presiding officer of their authenticity, relevancy, and materiality, be received in evidence and shall constitute part of the record.
(6) Oral argument shall be permitted. The presiding officer may limit oral presentations to relevant and material issues and designate the amount of time allowed for oral argument.
(f)(1) The presiding officer shall make an initial decision which shall include written findings and conclusions and the reasons therefore on all the material issues of fact, law, or discretion presented on the record. The findings, conclusions, and written decision shall be provided to the parties and made part of the record. The initial decision shall become the decision of the Administrator without further proceedings unless there is an appeal to, or review on motion of, the Administrator within 30 calendar days after the initial decision is filed.
(2) On appeal from or review of the initial decision, the Administrator will have all the powers consistent with making the initial decision, including the discretion to require or allow briefs, oral argument, the taking of additional evidence or the remanding to the presiding officer for additional proceedings. The decision by the Administrator will include written findings and conclusions and the reasons or basis therefore on all the material issues of fact, law, or discretion presented on the appeal or considered in the review.
§53.14 Modification of a reference or equivalent method.
(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).
(b) A report submitted under paragraph (a) of this section shall include:
(1) A description, in such detail as may be appropriate, of the intended modification.
(2) A brief statement of the applicant's belief that the modification will, will not, or may affect the performance characteristics of the method.
(3) A brief statement of the probable effect if the applicant believes the modification will or may affect the performance characteristics of the method.
(4) Such further information, including test data, as may be necessary to explain and support any statement required by paragraphs (b)(2) and (b)(3) of this section.
(c) Within 90 calendar days after receiving a report under paragraph (a) of this section, the Administrator will take one or more of the following actions:
(1) Notify the applicant that the designation will continue to apply to the method if the modification is implemented.
(2) Send notice to the applicant that a new designation will apply to the method (as modified) if the modification is implemented, submit notice of the determination for publication in the Federal Register, and revise or supplement the list referred to in §53.8(c) to reflect the determination.
(3) Send notice to the applicant that the designation will not apply to the method (as modified) if the modification is implemented and submit notice of the determination for publication in the Federal Register.
(4) Send notice to the applicant that additional information must be submitted before a determination can be made and specify the additional information that is needed (in such cases, the 90-day period shall commence upon receipt of the additional information).
(5) Send notice to the applicant that additional tests are necessary and specify which tests are necessary and how they shall be interpreted (in such cases, the 90-day period shall commence upon receipt of the additional test data).
(6) Send notice to the applicant that additional tests will be conducted by the Administrator and specify the reasons for and the nature of the additional tests (in such cases, the 90-day period shall commence 1 calendar day after the additional tests are completed).
(d) An applicant who has received a notice under paragraph (c)(3) of this section may appeal the Administrator's action as follows:
(1) The applicant may submit new or additional information pertinent to the intended modification.
(2) The applicant may request the Administrator to reconsider data and information already submitted.
(3) The applicant may request that the Administrator repeat any test conducted that was a material factor in the Administrator's determination. A representative of the applicant may be present during the performance of any such retest.
[62 FR 38784, July 18, 1997, as amended at 80 FR 65460, Oct. 26, 2015; 89 FR 16382, March 6, 2024]
§53.15 Trade secrets and confidential or privileged information.
Any information submitted under this part that is claimed to be a trade secret or confidential or privileged information shall be marked or otherwise clearly identified as such in the submittal. Information so identified will be treated in accordance with part 2 of this chapter (concerning public information).
§53.16 Supersession of reference methods.
(a) This section prescribes procedures and criteria applicable to requests that the Administrator specify a new reference method, or a new measurement principle and calibration procedure on which reference methods shall be based, by revision of the appropriate appendix to part 50 of this chapter. Such action will ordinarily be taken only if the Administrator determines that a candidate method or a variation thereof is substantially superior to the existing reference method(s).
(b) In exercising discretion under this section, the Administrator will consider:
(1) The benefits, in terms of the requirements and purposes of the Act, that would result from specifying a new reference method or a new measurement principle and calibration procedure.
(2) The potential economic consequences of such action for State and local control agencies.
(3) Any disruption of State and local air quality monitoring programs that might result from such action.
(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).
(d) After receiving an application under paragraph (c) of this section, the Administrator will publish notice of its receipt in the Federal Register and, within 120 calendar days after receipt of the application, take one of the following actions:
(1) Determine that it is appropriate to propose a revision of the appendix to part 50 of this chapter in question and send notice of the determination to the applicant.
(2) Determine that it is inappropriate to propose a revision of the appendix to part 50 of this chapter in question, determine whether the candidate method is a reference or equivalent method, and send notice of the determinations, including a statement of reasons for the determination not to propose a revision, to the applicant.
(3) Send notice to the applicant that additional information must be submitted before a determination can be made and specify the additional information that is needed (in such cases, the 120-day period shall commence upon receipt of the additional information).
(4) Send notice to the applicant that additional tests are necessary, specifying what tests are necessary and how the test shall be interpreted (in such cases, the 120-day period shall commence upon receipt of the additional test data).
(5) Send notice to the applicant that additional tests will be conducted by the Administrator, specifying the nature of and reasons for the additional tests and the estimated time required (in such cases, the 120-day period shall commence 1 calendar day after the additional tests have been completed).
(e)(1)(i) After making a determination under paragraph (d)(1) of this section, the Administrator will publish a notice of proposed rulemaking in the Federal Register. The notice of proposed rulemaking will indicate that the Administrator proposes:
(A) To revise the appendix to part 50 of this chapter in question.
(B) Where the appendix specifies a measurement principle and calibration procedure, to cancel reference method designations based on the appendix.
(C) To cancel equivalent method designations based on the existing reference method(s).
(ii) The notice of proposed rulemaking will include the terms or substance of the proposed revision, will indicate what period(s) of time the Administrator proposes to allow for replacement of existing methods under section 2.3 of appendix C to part 58 of this chapter, and will solicit public comments on the proposal with particular reference to the considerations set forth in paragraphs (a) and (b) of this section.
(2)(i) If, after consideration of comments received, the Administrator determines that the appendix to part 50 in question should be revised, the Administrator will, by publication in the Federal Register:
(A) Promulgate the proposed revision, with such modifications as may be appropriate in view of comments received.
(B) Where the appendix to part 50 (prior to revision) specifies a measurement principle and calibration procedure, cancel reference method designations based on the appendix.
(C) Cancel equivalent method designations based on the existing reference method(s).
(D) Specify the period(s) that will be allowed for replacement of existing methods under section 2.3 of appendix C to part 58 of this chapter, with such modifications from the proposed period(s) as may be appropriate in view of comments received.
(3) Canceled designations will be deleted from the list maintained under §53.8(c). The requirements and procedures for cancellation set forth in §53.11 shall be inapplicable to cancellation of reference or equivalent method designations under this section.
(4) If the appendix to part 50 of this chapter in question is revised to specify a new measurement principle and calibration procedure on which the applicant's candidate method is based, the Administrator will take appropriate action under §53.5 to determine whether the candidate method is a reference method.
(5) Upon taking action under paragraph (e)(2) of this section, the Administrator will send notice of the action to all applicants for whose methods reference and equivalent method designations are canceled by such action.
(f) An applicant who has received notice of a determination under paragraph (d)(2) of this section may appeal the determination by taking one or more of the following actions:
(1) The applicant may submit new or additional information in support of the application.
(2) The applicant may request that the Administrator reconsider the data and information already submitted.
(3) The applicant may request that any test conducted by the Administrator that was a material factor in making the determination be repeated.
Table A–1 to Subpart A of Part 53—Summary of Applicable Requirements for Reference and Equivalent Methods for Air Monitoring of Criteria Pollutants
| 1 Some requirements may apply, based on the nature of each particular candidate method, as determined by the Administrator. | |||||||||
| 2 Alternative Class III requirements may be substituted. | |||||||||
| Pollutant | Reference or equivalent | Manual or automated | Applicable appendix of part 50 of this chapter | Applicable subparts of this part | |||||
| A | B | C | D | E | F | ||||
| SO 2 | Reference | Manual | A–2 | ||||||
| Automated | A–1 | ✓ | ✓ | ||||||
| Equivalent | Manual | A–1 | ✓ | ✓ | |||||
| Automated | A–1 | ✓ | ✓ | ✓ | |||||
| CO | Reference | Automated | C | ✓ | ✓ | ||||
| Equivalent | Manual | C | ✓ | ✓ | |||||
| Automated | C | ✓ | ✓ | ✓ | |||||
| O 3 | Reference | Automated | D | ✓ | ✓ | ||||
| Equivalent | Manual | D | ✓ | ✓ | |||||
| Automated | D | ✓ | ✓ | ✓ | |||||
| NO 2 | Reference | Automated | F | ✓ | ✓ | ||||
| Equivalent | Manual | F | ✓ | ✓ | |||||
| Automated | F | ✓ | ✓ | ✓ | |||||
| Pb | Reference | Manual | G | ||||||
| Equivalent | Manual | G | ✓ | ✓ | |||||
| Automated | G | ✓ | ✓ | ||||||
| PM 10 -Pb | Reference | Manual | Q | ||||||
| Equivalent | Manual | Q | ✓ | ✓ | |||||
| Automated | Q | ✓ | ✓ | ||||||
| PM 10 | Reference | Manual | J | ✓ | ✓ | ||||
| Equivalent | Manual | J | ✓ | ✓ | ✓ | ||||
| Automated | J | ✓ | ✓ | ✓ | |||||
| PM 2.5 | Reference | Manual | L | ✓ | ✓ | ||||
| Equivalent Class I | Manual | L | ✓ | ✓ | ✓ | ||||
| Equivalent Class II | Manual | L 1 | ✓ | 2 ✓ | ✓ | ✓ | |||
| Equivalent Class III | Automated | L 1 | ✓ | ✓ | ✓ | 1 ✓ | |||
| PM 10–2.5 | Reference | Manual | L, 2 O | ✓ | ✓ | ||||
| Equivalent Class I | Manual | L, 2 O | ✓ | ✓ | ✓ | ||||
| Equivalent Class II | Manual | L, 2 O | ✓ | 2 ✓ | ✓ | 1,2 ✓ | |||
| Equivalent Class III | Automated | 1 L, O | ✓ | ✓ | ✓ | 1 ✓ | |||
[75 FR 35597, June 22, 2010; 89 FR 16382, March 6, 2024]
Appendix A to Subpart A of Part 53 - References
(1) American National Standard Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, ANSI/ISO/ASQC Q9001-1994. Available from American Society for Quality, P.O. Box 3005, Milwaukee, WI 53202 (http://qualitypress.asq.org).
(2) American National Standard Quality Systems for Environmental Data and Technology Programs - Requirements with guidance for use, ANSI/ASQC E4-2004. Available from American Society for Quality P.O. Box 3005, Milwaukee, WI 53202 (http://qualitypress.asq.org).
(3) Dimensioning and Tolerancing, ASME Y14.5M-1994. Available from the American Society of Mechanical Engineers, 345 East 47th Street, New York, NY 10017.
(4) Mathematical Definition of Dimensioning and Tolerancing Principles, ASME Y14.5.1M-1994. Available from the American Society of Mechanical Engineers, 345 East 47th Street, New York, NY 10017.
(5) ISO 10012, Quality Assurance Requirements for Measuring Equipment-Part 1: Meteorological confirmation system for measuring equipment):1992(E). Available from American Society for Quality Control, 611 East Wisconsin Avenue, Milwaukee, WI 53202.
(6) Quality Assurance Guidance Document 2.12. Monitoring PM 2.5 in Ambient Air Using Designated Reference or Class I Equivalent Methods. U.S. EPA, National Exposure Research Laboratory, Research Triangle Park, NC, November 1998 or later edition. Currently available at http://www.epa.gov/ttn/amtic/pmqainf.html.
[62 FR 38784, July 18, 1997, as amended at 71 FR 61278, Oct. 17, 2006]