97-18579. Revised Requirements for Designation of Reference and Equivalent Methods for PMINF2.5/INF and Ambient Air Quality Surveillance for Particulate Matter  

  • [Federal Register Volume 62, Number 138 (Friday, July 18, 1997)]
    [Rules and Regulations]
    [Pages 38764-38854]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-18579]
    
    
    
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    Part IV
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
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    40 CFR Parts 53 and 58
    
    
    
    Revised Requirements for Designation of Reference and Equivalent 
    Methods for PM2.5 and Ambient Air Quality Surveillance for 
    Particulate Matter; Final Rule
    
    Federal Register / Vol. 62, No. 138 / Friday, July 18, 1997 / Rules 
    and Regulations
    
    [[Page 38764]]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Parts 53 and 58
    
    [AD-FRL-5725-6]
    RIN 2060-AE66
    
    
    Revised Requirements for Designation of Reference and Equivalent 
    Methods for PM2.5 and Ambient Air Quality Surveillance for 
    Particulate Matter
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This final rule revises the 40 CFR part 58 ambient air quality 
    surveillance regulations to include provisions for PM2.5 
    (particulate matter with an aerodynamic diameter less than or equal to 
    a nominal 2.5 micrometers), as measured by a new reference method being 
    published in 40 CFR part 50, Appendix L, elsewhere in this issue of the 
    Federal Register or by an equivalent method designed in accordance with 
    requirements being promulgated in 40 CFR part 53. In addition, this 
    rule also revises existing ambient air quality monitoring requirements 
    for PM10 (particles with an aerodynamic diameter less than 
    or equal to 10 micrometers). These revisions address network design and 
    siting, quality assurance (QA) and quality control (QC), operating 
    schedule, network completion, system modifications, data reporting, and 
    other monitoring subjects.
    
    EFFECTIVE DATE: This regulation is effective September 16, 1997.
    
    ADDRESSES: All comments received relative to this rule have been placed 
    in Docket A-96-51, located in the Air Docket (LE-131), Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. The docket may 
    be inspected between 8 a.m. and 5:30 p.m., Monday through Friday, 
    excluding legal holidays. A reasonable fee may be charged for copying.
    
    FOR FURTHER INFORMATION CONTACT: For general information, contact 
    Brenda Millar (MD-14), Monitoring and Quality Assurance Group, 
    Emissions Monitoring, and Analysis Division, Environmental Protection 
    Agency, Research Triangle Park, North Carolina 27711, Telephone: (919) 
    541-5651, e-mail: millar.brenda@email.epa.gov. For technical 
    information, contact Neil Frank (MD-14), Monitoring and Quality 
    Assurance Group, Emissions, Monitoring, and Analysis Division, 
    Environmental Protection Agency, Research Triangle Park, North Carolina 
    27711, Telephone: (919) 541-5560.
    
    SUPPLEMENTARY INFORMATION:
    Table of Contents
    I. Authority
    II. Introduction
        A. Revision to the Particulate Matter NAAQS
        B. Air Quality Monitoring Requirements
    III. Discussion of Regulatory Revisions and Major Comments on 40 CFR 
    Part 53
        A. Designation of Reference and Equivalent Methods for 
    PM2.5
        B. Reference Method Designation Requirements
        C. Equivalent Method Designation Requirements
        D. Proposed Reference and Equivalent Method Requirements
        E. Changes to the Proposed Method Designation Requirements
    IV. Discussion of Regulatory Revisions and Major Comments on 40 CFR 
    Part 58
        A. Overview of Part 58 Regulatory Requirements
        B. Section 58.1 - Definitions
        C. Section 58.13 - Operating schedule
        D. Section 58.14 - Special purpose monitors
        E. Section 58.15 - Designation of monitoring sites
        F. Section 58.20 - Air quality surveillance: plan content
        G. Section 58.23 - Monitoring network completion
        H. Section 58.25 - System modification
        I. Section 58.26 - Annual State monitoring report
        J. Section 58.30 - NAMS network establishment
        K. Section 58.31 - NAMS network description
        L. Section 58.34 - NAMS network completion
        M. Section 58.35 - NAMS data submittal
        N. Appendix A - Quality Assurance Requirements for State and 
    Local Air Monitoring Stations (SLAMS)
        O. Appendix C - Ambient Air Quality Monitoring Methodology
        P. Appendix D - Network Design for State and Local Air 
    Monitoring Stations (SLAMS), National Air Monitoring Stations (NAMS) 
    and Photochemical Assessment Monitoring Stations (PAMS)
        Q. Appendix E - Probe and Monitoring Path Siting Criteria for 
    Ambient Air Quality Monitoring
        R. Appendix F - Annual Summary Statistics
        S. Review of Network Design and Siting Requirements for PM
        T. Resources and Cost Estimates for New PM Networks
    V. Reference
    VI. Regulatory Assessment Requirements
        A. Regulatory Impact Analysis
        B. Paperwork Reduction Act
        C. Impact on Small Entities
        D. Unfunded Mandates Reform Act of 1995
    
    I. Authority
    
        Section 110, 301(a), 313, and 319 of the Clean Air Act (Act) as 
    amended 42 U.S.C. 7410, 7601(a), 7613, 7619.
    
    II. Introduction
    
    A. Revision to the Particulate Matter NAAQS
    
        Elsewhere in this issue of the Federal Register, EPA announced 
    revisions to the national ambient air quality standards (NAAQS) for 
    particulate matter (PM). In that document EPA amends the current suite 
    of PM standards by adding PM2.5 standards and by revising 
    the form of the current 24-hour PM10 standard. Specifically, 
    EPA is adding two primary PM2.5 standards set at 15 
    g/m3, annual mean, and 65 g/m3, 
    24-hour average. The annual PM2.5 standard would be met when 
    the 3-year average of the annual arithmetic mean PM2.5 
    concentrations is less than or equal to 15 g/m3 
    from single or multiple community-oriented monitors in accordance with 
    40 CFR part 50, Appendix K and requirements set forth in this final 
    rule. The 24-hour PM2.5 standard would be met when the 3-
    year average of the 98th percentile of 24-hour PM2.5 
    concentrations at each population-oriented monitor within an area is 
    less than or equal to 65 g/m3.
        EPA also retained the current annual PM10 standard at 
    the level of 50 g/m3 which would be met when the 3-
    year average of the annual arithmetic PM10 concentrations at 
    each monitor within an area is less than or equal to 50 g/
    m3. Further, EPA retained the current 24-hour 
    PM10 standard at the level of 150 g/m3, 
    but revised the form such that the standard would be met when the 3-
    year average of the 99th percentile of the monitored concentrations at 
    the highest monitor in an area is less than or equal to 150 g/
    m3.
        In the part 50 final rule published elsewhere in this issue of the 
    Federal Register, EPA is also revising the current secondary standards 
    for PM by making them identical to the suite of primary standards. The 
    suite of PM2.5 and PM10 standards, in conjunction 
    with the establishment of a regional haze program under section 169A of 
    the Clean Air Act (the Act), are intended to protect against PM-related 
    welfare effects including soiling and materials damage and visibility 
    impairment.
        As discussed in the part 50 final rule for the PM NAAQS, the 
    PM2.5 standards are intended to protect against exposures to 
    fine particulate pollution, while the PM10 standards are 
    intended to protect against coarse fraction particles as measured by 
    PM10.
        For PM2.5, the annual standard is intended to protect 
    against both long- and short-term exposures to fine particle pollution. 
    Under this approach, the PM2.5 24-hour standard would serve 
    as a supplement to PM2.5 annual standard
    
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    to provide additional protection against days with high 
    PM2.5 concentrations, localized ``hot spots,'' and risks 
    arising from seasonal emissions that would not be well controlled by a 
    national annual standard.
        In specifying that the calculation of the annual arithmetic mean 
    for an area (for purposes of comparison to level of PM2.5 
    annual standard) should be accomplished by comparing the annual mean 
    from a community-oriented monitor that is representative of average 
    community-wide exposure, or averaging the annual arithmetic means 
    derived from multiple, community-oriented monitoring sites, EPA took 
    into account several factors. As discussed in the part 50 final rule, 
    many of the community-oriented epidemiologic studies examined in this 
    review used spatial averages, when multiple monitoring sites were 
    available, to characterize area-wide PM exposure levels and associated 
    public health risk. In those studies that used only one monitoring 
    location, the selected site was chosen to represent community-wide 
    exposures, not the highest value likely to be experienced within the 
    community. Because the annual PM2.5 standard is intended to 
    reduce aggregate population risk from both long- and short-term 
    exposures by lowering the broad distribution of PM concentrations 
    across the community, an annual standard based on monitoring data 
    reflecting average community wide exposure would better reflect area-
    wide PM2.5 exposure levels and associated health risks than 
    would a standard based on concentrations from a single monitor with the 
    highest measured values in the area. The concept of average community 
    exposures is not appropriate for PM10 because the spatial 
    distribution of coarse particles is different and tends to be more 
    localized in its behavior.
        Finally, under the policy approach presented in the part 50 final 
    rule, the 24-hour PM2.5 standard is intended to supplement 
    an annual PM2.5 standard by providing protection against 
    peak 24-hour concentrations arising from situations that would not be 
    well-controlled by an annual standard. Accordingly, the 24-hour 
    PM2.5 standard will be based on the single population-
    oriented monitoring site within a monitoring planning area with the 
    highest measured values.
        In EPA's judgment, an annual PM2.5 standard based on 
    monitoring data representative of community average air quality, 
    established in conjunction with a 24-hour standard based on the 
    population-oriented monitoring site with the highest measured values, 
    will provide the most appropriate target for reducing area-wide 
    population exposure to fine particle pollution and will be most 
    consistent with the underlying epidemiological data base.
    
    B. Air Quality Monitoring Requirements
    
        A new Federal Reference Method (FRM) for PM2.5 is 
    promulgated in a new Appendix L to 40 CFR part 50. Section 319 of the 
    Act requires that uniform criteria be followed when measuring ambient 
    air quality. To satisfy these requirements, EPA established procedures 
    on February 10, 1975, in 40 CFR part 53 for the determination and 
    designation of reference or equivalent monitoring methods (40 FR 7049). 
    Accordingly, new provisions are added to 40 CFR part 53 so that each 
    reference method for PM2.5, based on a particular sampler, 
    will be formally designed as such by EPA. Similarly, samplers 
    demonstrated as equivalent to the FRM can also be designated. 
    Furthermore, section 110(a)(2)(C) of the Act requires ambient air 
    quality monitoring for purposes of the State Implementation Plans 
    (SIPs) and for reporting data quality to EPA. Uniform criteria to be 
    followed when measuring air quality and provisions for daily air 
    pollution index reporting are required by section 319 of the Act.1 
    To satisfy these requirements, on May 10, 1979 (44 FR 27558), EPA 
    established 40 CFR part 58 which provided detailed requirements for air 
    quality monitoring, data reporting, and surveillance for all of the 
    pollutants for which national ambient air quality standards have been 
    established (criteria pollutants). Provisions were promulgated 
    subsequently for PM measured as PM10 on July 1, 1987 (52 FR 
    24740); provisions for PM2.5 are published in this final 
    rule.
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        1EPA intends to develop and propose for public comment a revised 
    Pollutant Standards Index that will address PM2.5 as well 
    as PM10, at a later date.
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        On December 13, 1996, these rules were proposed in the Federal 
    Register as amendments to 40 CFR parts 53 and 58. The intent of the 
    monitoring method designations and air quality surveillance 
    requirements being promulgated today are to establish a revised 
    particulate matter monitoring network that will produce air quality 
    data utilizing uniform criteria for the purpose of comparison to the 
    revised primary and secondary PM NAAQS and to facilitate implementation 
    of a forthcoming regional haze program. The effective date of today's 
    monitoring regulation is September 16, 1997.
    
    III. Discussion of Regulatory Revisions and Major Comments on 40 
    CFR Part 53
    
    A. Designation of Reference and Equivalent Methods for PM2.5
    
        Provisions for EPA designation of reference and equivalent methods 
    for PM10 and gaseous criteria pollutants have been 
    previously established and are set forth in 40 CFR part 53. On December 
    13, 1996, EPA proposed to amend part 53 to add new provisions to govern 
    designation of reference and equivalent method for PM2.5. 
    The December 13th notice proposed new, detailed sampler testing and 
    other requirements that would apply to candidate reference and 
    equivalent PM2.5 methods and describes how EPA proposed to 
    determine whether a candidate method should be designated as either a 
    reference or equivalent method. The notice further solicited public 
    comments on the proposed new provisions. Those provisions, modified 
    somewhat based on the public comments received, are being promulgated 
    today as amended part 53.
        As for the other criteria air pollutants, reference methods for 
    PM2.5 are intended to provide for uniform, reproduceable 
    measurements of PM2.5 concentrations in ambient air to serve 
    as a measurement standard for the primary purpose of making comparisons 
    to the NAAQS. Equivalent methods for PM2.5 allow for the 
    consideration and introduction of new and innovative PM2.5 
    measurement technologies for this same purpose, provided such new 
    technologies can be shown to provide PM2.5 measurements 
    comparable to reference measurements under a variety of typical 
    monitoring conditions.
    
    B. Reference Method Designation Requirements
    
        The new reference method for PM2.5, described in 40 CFR 
    part 50, Appendix L contains a combination of design and performance 
    specifications to define the reference method PM2.5 sampler. 
    The performance-based specifications for the reference method sampler 
    allow manufacturers to design and fabricate different samplers that 
    would meet all reference method requirements. Accordingly, multiple 
    PM2.5 reference methods are expected to become available 
    from several manufacturers, as is the case for reference methods for 
    PM10 and most gaseous criteria pollutants. Each reference 
    method for PM2.5, based on a particular sampler, will be 
    formally designated as such by EPA under the new provisions added to 40 
    CFR part 53.
    
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        The requirements for designation of PM2.5 reference 
    methods are set forth in subparts A and E of 40 CFR part 53. These 
    requirements include specific tests to show conformance with all design 
    and performance specifications, an operational field precision test, a 
    comprehensive operation/instruction manual, and documentation of an 
    adequate manufacturing and testing quality system. Subpart A, which has 
    been amended to add provisions for PM2.5 methods, sets forth 
    the general requirements for both reference and equivalent methods and 
    for the process under which applications are submitted and reference 
    and equivalent method are designated. New subpart E, which is devoted 
    exclusively to PM2.5 methods, describes the test procedures 
    and related requirements for candidate reference methods.
    
    C. Equivalent Method Designation Requirements
    
        The requirements for designation of equivalent methods for 
    PM2.5 are also set forth in amended part 53. The general 
    requirements are set forth in subpart A. All candidate equivalent 
    methods are subject to the field tests for operational precision and 
    comparability to reference method measurements, which are specified in 
    subpart C. Both subparts A and C have been amended to include the 
    provisions for PM2.5 methods.
        To minimize the number and extent of performance tests to which 
    candidate equivalent methods must be subjected, three classes of 
    equivalent methods are defined.
        Class I equivalent methods are based on samplers that have 
    relatively small deviations from the specifications for reference 
    method samplers. Therefore, in addition to the tests and other 
    requirements applicable reference method samplers, candidate Class I 
    equivalent samplers must be tested only to make sure that the 
    modifications do not significantly compromise sampler performance. The 
    additional test requirements for most Class I candidate equivalent 
    methods are a test for possible loss of PM2.5 in any new or 
    modified components in the sampler inlet upstream of the sample filter, 
    and the field testing for comparability to reference method samplers. 
    These additional tests are described in subparts E and C, respectively.
        Class II equivalent methods include all other PM2.5 
    methods that are based on a 24-hour integrated filter sample that is 
    subjected to subsequent moisture equilibration and gravimetric mass 
    analysis. A sampler associated with a Class II equivalent method will 
    generally have one or more substantial deviations from the design or 
    performance specifications of the reference method, such that it cannot 
    qualify as a Class I equivalent method. These samplers may have a 
    different inlet, a different particle size separator, a different 
    volumetric flow rate, a different filter or filter face velocity, or 
    other significant differences. More extensive performance testing is 
    required for designation of Class II candidate equivalent methods, with 
    the specific tests required depending on the nature and extent of the 
    differences between the candidate sampler and the specifications for 
    reference method samplers. These tests may include a full wind tunnel 
    evaluation, a wind tunnel inlet aspiration test, a static fractionator 
    test, a fractionator loading test, a volatility test, and field testing 
    against reference method samplers. The tests and their specific 
    applicability to various types of candidate Class II equivalent method 
    samplers are set forth in the new subpart F.
        Finally, Class III equivalent methods include any candidate 
    PM2.5 methods that cannot qualify as either Class I or Class 
    II. This class includes any filter-based integrated sampling method 
    having other than a 24-hour PM2.5 sample collection interval 
    followed by moisture equilibration and gravimetric mass. More 
    importantly, Class III also includes filter-based continuous or semi-
    continuous methods, such as beta attenuation instruments, harmonic 
    oscillating element instruments, and other complete in situ monitor 
    types. Non-filter-based methods such as nephelometry or other optical 
    instruments will also fall into the Class III category.
        The testing requirements for designation of Class III candidate 
    methods are the most stringent, because quantitative comparability to 
    the reference method will have to be shown under various potential 
    particle size distributions and aerosol composition. However, because 
    of the variety of measurement principles and types of methods possible 
    for Class III candidate equivalent methods, the test requirements must 
    be individually selected or specifically designed or adapted for each 
    such type of method. Therefore, EPA has determined that it is not 
    practical to attempt to develop and explicitly describe the test 
    procedures and performance requirements for all of these potential 
    Class III methods a priori. Rather, the specific test procedures and 
    performance requirements applicable to each Class III candidate method 
    will be determined by EPA on a case-by-case basis upon request, in 
    connection with each proposed or anticipated application for a Class 
    III equivalent method determination.
    
    D. Proposed Reference and Equivalent Method Requirements
    
        The proposed changes to 40 CFR part 53 to provide for designation 
    of reference and equivalent methods for PM2.5 consisted of 
    revisions to subparts A and C, and new subparts E and F. The proposed 
    revisions to subpart A included new definitions applicable to 
    PM2.5 methods and clarifications of existing definitions, 
    clarifications of the reference and equivalent method designation 
    requirements for all pollutants including the new classes of equivalent 
    methods for PM2.5, and requirements for PM2.5 
    samplers to be manufactured in an International Organization for 
    Standardization (ISO) 9001-registered facility (or equivalent). 
    Additional proposed changes included clarifications of the test data 
    and other information required to be submitted in applications for a 
    reference or equivalent method determination, clarification of 
    requirements for product warranty and content of operation or 
    instruction manuals, an increased time limit for processing 
    applications; and provisions for providing EPA with a candidate test 
    PM2.5 sampler or analyzer to evaluate in connection with an 
    application for reference or equivalent method determination.
        Revisions to subpart C included new procedures and specifications 
    for comparing candidate equivalent methods for PM2.5 to 
    reference method samplers. The entirely new subpart E described the 
    technical procedures for testing the physical (design) and performance 
    characteristics of reference methods and Class I equivalent candidate 
    methods for PM2.5. The new subpart F described the 
    procedures for testing the performance characteristics of Class II 
    equivalent methods for PM2.5.
    
    E. Changes to the Proposed Method Designation Requirements
    
        The tests of the design and performance characteristics of 
    candidate samplers for designating reference methods as well as 
    equivalent methods are intimately related to the specifications for 
    reference methods in 40 CFR part 50, Appendix L. Many of the concerns 
    expressed by commenters regarding the reference method for 
    PM2.5 in 40 CFR part 50, Appendix L also apply to some of 
    the provisions of part 53. Other comments were more directly concerned 
    with the provisions of 40 CFR part 53, and these comments are 
    summarized in this unit.
    
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        Several commenters addressed the responsibilities of EPA and 
    manufacturers in the method designation process. Specific comments 
    included the suggestions that: (1) It would be more appropriate for EPA 
    to conduct the necessary testing of a candidate method before 
    designating a reference method; (2) that EPA should clarify how it will 
    respond to possible poor sampler performance under extreme 
    environmental conditions encountered in some areas of the United 
    States, since the samplers are not required to meet such extreme 
    conditions; (3) that EPA should clarify that specifications for 
    completing sampler modifications or retrofits to work in nonstandard 
    environments should be included as part of a sampler purchase contract; 
    and (4) that EPA should clarify that the required method specifications 
    must be met throughout the warranty period and that the applicant 
    accepts responsibility and liability for ensuring conformance or 
    resolving nonconformities, including all necessary components of the 
    system, regardless of the original manufacturer.
        The new provisions contained in the modified 40 CFR part 53 require 
    the applicant to submit information and documentation to demonstrate 
    that the applicant's candidate reference method sampler meets all 
    design specifications set forth in 40 CFR part 50, Appendix L. The 
    provisions also require the applicant to carry out specific tests to 
    demonstrate that the candidate reference or equivalent method meets all 
    performance specifications. The nature of these tests and the 
    requirement that they be carried out by the applicant rather than by 
    EPA is consistent with the previously established requirements in 40 
    CFR part 53 for designating reference or equivalent methods for other 
    criteria pollutants. Section 53.9 clearly states that a sampler sold as 
    part of a designated method must meet the applicable performance 
    specifications for at least 1 year after delivery. Section 53.9 further 
    requires that ISO 9001 registration of the manufacturing facility be 
    maintained and that a Product Manufacturing Checklist signed by a 
    certified ISO auditor be submitted annually to verify manufacturing 
    quality control.
        In response to concerns about the performance of the sampler under 
    extreme weather conditions, EPA has established sampler specifications 
    that are intended to cover reasonably normal environmental conditions 
    at about 95 percent of expected monitoring sites. The performance tests 
    in subpart E address essentially all of these operational requirements. 
    Specification of the sampler performance for sites with extreme 
    environmental conditions would substantially raise the cost of the 
    sampler for users, most of whom do not require the extra capability. 
    EPA strongly recommends that users requiring operation of samplers 
    under extreme environmental conditions develop supplemental 
    specifications for modified samplers to cover those specific 
    conditions. Sampler manufacturers have indicated a commitment to 
    respond to such special operational needs.
        Documentation is required to demonstrate that samplers to be sold 
    as reference or equivalent methods for PM2.5 will be 
    manufactured under an effective quality control system. Although some 
    commenters supported the general quality assurance concepts contained 
    in the proposed method, several questioned the inclusion of the ISO 
    9001-registration requirement. EPA believes that the ISO 9001-
    registration requirement and related provisions are the most cost-
    effective way to ensure that samplers are manufactured in a facility 
    conforming to internationally recognized quality system standards.
        Several comments questioned the proposed requirement that each 
    PM2.5 sampler model be subjected to a specific annual 
    evaluation of performance and meet certain operating performance 
    specifications. In response to these comments, this requirement has 
    been deleted. However, EPA will review the performance of each 
    PM2.5 sampler model on an annual basis, and if compelling 
    evidence indicates a significant bias or other operational problem, the 
    EPA Administrator may make a preliminary finding to cancel a reference 
    or equivalent method designation in accordance with the provisions of 
    Sec. 53.11 in subpart A.
        Otherwise, the provisions of 40 CFR part 53 have been retained to 
    conform with the requirements described in 40 CFR part 50, Appendix L. 
    The proposed revisions to subparts A and C have been retained with no 
    substantive changes. However, minor technical and editorial changes 
    have been made to subparts A and C to clarify or simplify proposed 
    provisions. Subpart E has undergone extensive revision and 
    reorganization. Although these changes do not affect the objectives and 
    nature of the tests, they are intended to make the test requirements 
    easier to understand and the tests easier to perform. The changes were 
    based on EPA's own experience in performing tests of prototype 
    candidate samplers and on comments from prospective sampler 
    manufacturers. Subpart F has also been revised to some extent. The 
    changes to subpart F are not substantive in nature, but numerous 
    technical and editorial changes were made to clarify the test 
    requirements and make the tests, particularly the volatility test, more 
    straightforward to carry out.
        All testing related to an application for a PM2.5 
    reference or equivalent method determination under 40 CFR part 53 must 
    be carried out in accordance with American National Standards 
    Institute/American Society for Quality Control (ANSI/ASQC) E4 
    standards. These requirements are necessary to ensure that all samplers 
    or analyzers sold as reference or equivalent methods are manufactured 
    and tested to the high standards required to achieve the needed data 
    quality. These procedures are in keeping with the developing 
    international standards for manufacturing and testing in this and other 
    industries.
    
    IV. Discussion of Regulatory Revisions and Major Comments on Part 
    58
    
        The following discussion presents an overview of the final part 58 
    monitoring regulation. This is followed by a detailed discussion of the 
    basic concepts outlined in the December 13, 1996 monitoring proposal 
    and addresses those comments received on the proposed part 58 
    regulations that EPA considered to be most relevant to the changes and 
    additions adopted in the final rule. Comments not addressed in this 
    preamble are found in a Summary and Response to Comment document that 
    has been placed in Docket A-96-51. Those parts of the proposed 
    regulations which were not commented on have not been changed. The 
    items are discussed in the order in which they appear in the 
    regulation.
    
    A. Overview of Part 58 Regulatory Requirements
    
        The requirements set forth in this rule simultaneously preserve the 
    underlying intent of the revised NAAQS and respond positively to the 
    very substantial and reasoned comments received on the proposal. 
    Specifically, the major monitoring requirements and principles set 
    forth by the revised part 58 regulation include:
        1. PM2.5 network design. Community-oriented (core) 
    monitors that represent community-wide average exposure, form the basis 
    of PM2.5 network design. This approach is consistent with 
    the data bases used to develop the NAAQS. While all population-oriented 
    monitoring locations are eligible for comparison to the 24-hour 
    PM2.5 NAAQS, only locations representative of neighborhood 
    or larger spatial scales
    
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    are eligible for comparison to the annual NAAQS. Community monitoring 
    zones with constrained criteria may be also used to define monitors 
    acceptable for spatial averaging for comparison to the annual NAAQS. 
    Monitoring for regional transport and regional background is required 
    to assist with implementation of the air quality management program. 
    The combination of emphasis on well-sited community-oriented monitors 
    and the feasibility by the States to select the preferred community 
    monitoring approach reduces complexity associated with network design 
    and planning. The number of required core PM2.5 State and 
    Local Air Monitoring Stations (SLAMS), and other PM2.5 SLAMS 
    results in a minimum national requirement of approximately 850 
    PM2.5 sites (compared to 629 proposed); the total 
    PM2.5 network is projected to approach 1,500 
    PM2.5 sites. Exceptions to the minimum number of required 
    samplers may be approved by the EPA Regional Administrator. As 
    proposed, the mature network of 1,500 PM2.5 sites would be 
    in place within 3 years. The phase-in of the required network has been 
    reduced from 3 to 2 years.
        2. PM10 monitoring networks. Requirements for 
    PM10 network design and siting are unchanged. Reductions in 
    PM10 networks are encouraged in areas of low concentrations 
    where the PM10 NAAQS are not expected to be violated.
        3. Sampling frequencies. The sampling frequencies stipulated in 40 
    CFR 58.13 for both PM2.5 and PM10, have been 
    modified to reflect a one in 3-day minimum requirement. Required every 
    day sampling at certain core sites may be reduced to one in 3-day 
    sampling after at least 3 complete years of data collection with a 
    reference or equivalent method or when collocated with a correlated 
    acceptable continuous (CAC) fine particulate monitor; background and 
    regional transport may also sample once every third day. Exceptions to 
    the minimum requirement may be approved by the EPA Regional 
    Administrator for seasonal or year-round sampling.
        4. Chemical speciation. A modest chemical speciation network of 50 
    PM2.5 sites that provides a first order characterization of 
    the metals, ions, and carbon constituents of PM2.5 is a 
    requirement of this rule. These sites will be part of the National Air 
    Monitoring Stations (NAMS) network and will provide national 
    consistency for trends purposes and serve as a model for other chemical 
    speciation efforts. This required network represents a small fraction 
    of all the chemical speciation work that EPA expects to support with 
    Federal funds. Additional efforts may be used to enhance the required 
    network and tailor the collection and analysis of speciated data to the 
    needs of individual areas.
        5. Quality assurance. The QA program is collectively based on a 
    variety of QA tools resulting in a program which is more efficient, 
    less costly, and relaxes the burden on State and local agencies. The 
    key program requirements include:
        a. Independent field audits with a PM2.5 FRM are used to 
    evaluate the bias of PM2.5 measurements. The number of 
    PM2.5 audited sites compared to the proposal are reduced 
    from all non-collocated sites to 25 percent of all SLAMS sites 
    (including NAMS) and the audit frequency per site is reduced from 6 to 
    4 visits per year.
        b. Flow checks will also be used to evaluate bias of 
    PM2.5 and PM10 measurements and are conducted on 
    a quarterly basis as proposed.
        c. Collocation with PM2.5 FRM and Federal Equivalent 
    Methods (FEM) samplers at SLAMS sites is used to judge precision. The 
    number of collocated sites per reporting organization is 25 percent of 
    all PM2.5 SLAMS sites (20 percent were proposed) and 
    approximately 20 percent of all PM10 SLAMS sites (which is 
    current practice).
        d. Systems audits are used to evaluate an agency's QA system and 
    will be performed by EPA every 3 years as originally proposed.
        In an effort to assist the State and local agencies in achieving 
    the data quality objectives of the PM2.5 monitoring program, 
    an incentive program has been established that is based on network 
    performance and maturity that can reduce these QA requirements.
        6. Moratorium on the use of special purpose monitor (SPM) data. The 
    moratorium on the use of PM2.5 data (Sec. 58.14) collected 
    by SPMs, has been changed from the first 3 calendar years following the 
    effective date of this rule to the first 2 complete calendar years of 
    operation of a new SPM. If such monitors produce valid data for more 
    than 2 years, then all historical data for that site may be used for 
    regulatory purposes.
        7. Monitoring methodology. Appendix C has been revised to allow the 
    use of Interagency Monitoring of Protected Visual Environments 
    (IMPROVE) samplers at regional transport and regional background sites 
    to satisfy the SLAMS requirements.
        8. PM monitoring network description. The State shall submit a PM 
    monitoring network description to the EPA Regional Administrator by 
    July 1, 1998, which describes the PM monitoring network, its intended 
    community monitoring approach for comparison to the annual 
    PM2.5 standard, use of non-population-oriented special 
    purpose PM2.5 monitors or alternative samplers, and proposed 
    exceptions to EPA's requirements for minimum number of monitors or 
    sampling frequency. The description shall be available for pubic 
    inspection and EPA shall review and approve/disapprove the document 
    within 60 days. A State air monitoring report with proposed network 
    revisions, if any, shall be submitted annually.
        EPA believes that the aforesaid revisions to the rule, as proposed, 
    provide a firm basis for the uniform implementation of a national 
    particulate monitoring network which is responsive to a revised NAAQS 
    expressed as PM2.5. The following is a section-by-section 
    discussion of comments received and any resulting modifications to the 
    proposal.
    
    B. Section 58.1 - Definitions
    
        EPA proposed to add several definitions applicable to PM 
    monitoring. This consisted of revising the definition of the term 
    traceable and definitions of the terms Consolidated Metropolitan 
    Statistical Area (CMSA), core SLAMS, equivalent methods, Metropolitan 
    Statistical Area (MSA), monitoring planning area (MPA), monitoring 
    plan, PM2.5, Primary Metropolitan Statistical Area (PMSA), 
    population-oriented, reference method, spatial averaging zone (SAZ), 
    SPM fine monitors, and Annual State Monitoring Report. In response to 
    comments, EPA is modifying the proposed approach and is introducing new 
    terminology and definitions. First, EPA is changing the definition of 
    core SLAMS monitors to describe community-oriented monitors that are 
    representative of neighborhood or larger spatial scales and will be key 
    monitoring entities in the new PM2.5 SLAMS network. As 
    discussed later, a subset of these monitors will be required to sample 
    everyday in the most populated metropolitan areas with the stated 
    emphasis on community-oriented monitoring. Although very important, the 
    background and regional transport monitors in the SLAMS network are no 
    longer called core sites. Secondly, EPA is replacing the definition of 
    spatial averaging zone with a definition of community monitoring zone 
    (CMZ). This is consistent with the intent of the annual 
    PM2.5 standard, that is to be judged at monitoring stations 
    that are representative of community-wide air quality. EPA is also 
    renaming the PM monitoring plan as the PM monitoring network 
    description. EPA's rationale for
    
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    these changes, together with a more complete description of community 
    monitoring zones, are discussed in 40 CFR part 58, Appendix D.
        In addition, several commenters addressed the definition of 
    population-oriented monitoring, objecting to the narrowness of the 
    definition with respect to industrial areas, and noting that if people 
    are present in an area, the site should be considered population-
    oriented.
        EPA assessed these comments and concluded that the definition of 
    population-oriented monitoring or sites proposed in Sec. 58.1 is 
    essentially appropriate and as such will provide monitoring agencies 
    with the flexibility to design networks that are consistent with the 
    population-oriented approach described by the PM2.5 
    standards. Therefore EPA is retaining this definition in the final rule 
    with a minor simplifying change as follows: population-oriented 
    monitoring (or sites) applies to residential areas, commercial areas, 
    recreational areas, industrial areas and other areas where a 
    substantial number of people may spend a significant fraction of their 
    day. The definition of population-oriented monitoring will be further 
    deliniated in future EPA guidance. As proposed, the final rule states 
    that all population-oriented PM2.5 monitoring locations 
    shall be eligible for comparison to both the 24-hour PM10 
    and PM2.5 standards. In order to make these concepts clearer 
    for the final rule, however, several changes to the proposed language 
    were made in the final rule regarding eligibility of monitoring sites 
    for comparisons to the PM2.5 NAAQS. First, the new 
    PM2.5 network will place emphasis on community-oriented 
    monitoring for making comparisons to both the annual and 24-hour 
    PM2.5 NAAQS. Secondly, as proposed, unique population-
    oriented microscale and middle-scale monitoring sites shall only be 
    used for comparisons to the 24-hour NAAQS. Furthermore, violations 
    detected at rural background and regional transport sites are more 
    appropriately addressed by the implementation program which EPA is 
    developing.
    
    C. Section 58.13 - Operating Schedule
    
        EPA proposed that core PM2.5 SLAMS (including NAMS and 
    core SLAMS collocated at Photochemical Assessment Monitoring Stations 
    (PAMS) sites) would be required to sample every day, unless an 
    exception is approved by EPA during established seasons of low PM 
    pollution during which time a minimum of one in 6-day sampling would be 
    permitted. The proposal stated that non-core SLAMS sites would 
    generally be required to sample a minimum of once every sixth day, 
    although episodic or seasonal sampling could also be possible (e.g., in 
    areas where significant violations of the 24-hour NAAQS are expected or 
    at sites heavily influenced by regional transport or episodic 
    conditions). The proposed and final rule state that special purpose 
    monitors may sample on any sampling schedule. The proposal also 
    recognized that although daily sampling with manual methods is labor 
    intensive due to site visits and filter equilibration and weighing, 
    semi-automatic sequential samplers are anticipated to be approvable as 
    FRMs or Class I equivalent samplers (under the provisions of part 53) 
    that will simplify the data collection process. Finally, EPA proposed 
    that alternative PM2.5 operating schedules that combine 
    intermittent sampling with the use of acceptable continuous fine 
    particulate samplers are approvable at some core sites. This 
    alternative was intended to give the States additional flexibility in 
    designing their PM2.5 monitoring networks and to permit data 
    from continuous instruments to be telemetered. This would facilitate 
    public reporting of fine particulate concentrations, and allow air 
    pollution alerts to be issued, and allow episodic controls to be 
    implemented (as currently done in woodburning areas for 
    PM10). Furthermore, this alternative would permit monitoring 
    agencies to take advantage of new and improved monitoring technologies 
    that should become available during the first few years following the 
    promulgation of this rule. As proposed, applicability does not apply to 
    areas with population greater than 1 million during the first 2 years 
    of required sampling.
        Many commenters supported daily PM2.5 sampling, citing 
    the need to target sources, aid enforcement, and provide exposure 
    measurements for future community health studies. Additionally, 
    commenters supported daily PM2.5 sampling to cover the most 
    polluted and most populated areas and to capture all violations. Other 
    commenters supported daily sampling but suggested limiting it to key 
    locations or seasons (e.g., only the largest metropolitan areas or 
    those areas with the highest PM2.5 concentrations, only 
    during seasons when high values are likely). Other commenters suggested 
    allowing a reduction in sampling frequency to one in 6 days under 
    certain conditions; for example, at sites that have demonstrated 
    attainment, at sites with CAC analyzers, following the third year of 
    data collection, and during the portion of the year with low 
    PM2.5 concentrations at a site with a district seasonal 
    pattern.
        In addition, a number of commenters suggested a delay of everyday 
    sampling until the Class I equivalent samplers are available. It was 
    noted that over the short-term, only designated manual samplers capable 
    of collecting single 24-hour samples, could be available. Consequently, 
    to meet an everyday sampling schedule, several samplers would need to 
    be installed at each everyday sampling site to satisfy the daily 
    schedule, and cover weekend and holiday sampling periods.
        Based on its review of these comments, EPA is retaining its 
    everyday sampling schedule for certain community-oriented (core) SLAMS 
    (i.e., two monitoring sites in each MSA greater than 500,000 population 
    and SLAMS collocated at PAMS for a total of 313 nationwide). The 
    remaining SLAMS including NAMS and other core SLAMS are required to 
    sample every third day.
        Because of concerns over the potential unavailability of Class I 
    sequential samplers, EPA is allowing a waiver of the everyday or every 
    third day sampling schedule, when appropriate, in those situations 
    where such sampling is not needed. This waiver would expire 1 calendar 
    year from the time a sequential sampler has been approved by EPA. When 
    the waiver is granted for every day sampling, one in 3-day sampling 
    would be required. As proposed, EPA encourages the use of a 
    supplemental CAC analyzer as a means of facilitating a reduction of the 
    reference or equivalent method everyday sampling schedule to once in 3 
    days. The CAC monitoring option, however, will not be allowed in areas 
    greater than 1 million population that have high PM2.5 
    concentrations during the first 2 years of daily data collection. A 
    minimum frequency of one in 6-day sampling is still required during 
    periods for which exemptions to everyday or every third day sampling 
    are allowed for PM2.5 SLAMS.
        For PM10, the EPA Administrator proposed that one in 6-
    day sampling should be sufficient to support the proposed 
    PM10 NAAQS and a less dense monitoring network would also be 
    needed.
        A number of commenters supported the typical one in 6-day sampling 
    frequency for PM10. On the other hand, a number of 
    commenters opposed the proposed reduction in PM10 sampling 
    frequency to one in 6 days, stating that one in 6-day sampling is 
    inadequate to evaluate impacts on the 24-hour PM10
    
    [[Page 38770]]
    
    standard, especially in areas with episodic events or localized hot 
    spots, and that extreme pollutant conditions could be missed.
        In response to the general concerns that sampling for 
    PM10 is not sufficient and in accordance with the choice of 
    the 99th percentile as the form of the 24-hour PM10 
    standards as discussed in 40 CFR part 50, EPA has changed the minimum 
    required sampling frequency from one sample every 6 days to one sample 
    in every 3 days.
        The specified minimum sampling frequency of one in 3 days for 
    PM2.5 and PM10 will provide for a more 
    statistically stable representation of actual air quality at each 
    monitor as discussed in 40 CFR part 50. Further, increasing the 
    sampling frequency from one in 6- to one in 3-days will ensure that the 
    24-hour NAAQS comparisons are not based on the highest measured values 
    per year, and thus will significantly reduce the chances of incorrectly 
    classifying a ``clean'' area as nonattainment, and at the same time 
    provide enough information to confidently classify ``dirty'' areas as 
    nonattainment without requiring those areas to sample every day.
        EPA believes that once in 6-day sampling is sufficient to estimate 
    an annual mean concentration for PM2.5 or PM10. 
    Furthermore, every day or every third day sampling is not generally 
    needed during periods of the lowest ambient PM concentrations. 
    Therefore, EPA is allowing exemptions to the every day or the one in 3-
    day sampling requirement to individual areas with the approval of the 
    EPA Regional Administrator, in accordance with forthcoming EPA 
    guidance. In general, exemptions to the minimum one in 3-day sampling 
    frequency will be approvable when existing information suggests that 
    maximum 24-hour measurements are less than the level of the standard. 
    In these cases, a minimum of one in 6-day sampling will be required to 
    ensure that sufficient data are available to calculate an annual 
    average concentration. Areas adopting less frequent sampling would be 
    advised of the risks involved in such a choice; namely, that a single 
    high value in 1 year could end up causing the area to be declared in 
    violation of the 24-hour NAAQS. The guidance will also recommend that 
    more frequent sampling be considered for those areas that are 
    relatively close to the level of the standard. For example, areas whose 
    PM2.5 or PM10 data indicate that they meet the 
    annual PM NAAQS, but have the potential to not meet the 24-hour PM 
    NAAQS will be encouraged to sample everyday for PM2.5 or 
    PM10, as appropriate, during the high PM seasons in order to 
    better assess their status to the standards. While such an option may 
    be more costly for individual areas, the risk of inaccurately declaring 
    an attainment area to be nonattainment would be reduced.
    
    D. Section 58.14 - Special Purpose Monitors
    
        EPA proposed that special purpose monitoring (SPM) is needed in a 
    new PM2.5 monitoring program to help identify potential 
    problems, to help define boundaries of problem areas, to better define 
    temporal (e.g., diurnal) patterns, to determine the spatial scale of 
    high concentration areas, and to help characterize the chemical 
    composition of PM (using alternative samplers and supplemental 
    analyzers), especially on high concentration days or during special 
    studies. It was proposed, however, that data from SPMs would not be 
    used for attainment/nonattainment designations if the monitor is 
    located in an unpopulated area, if the monitoring method is not a 
    reference or equivalent method or does not meet the requirements of 
    section 2.4 of 40 CFR part 58, Appendix C. Moreover, in order to 
    encourage the deployment of SPMs, EPA proposed that nonattainment 
    designations will not be based on data produced at an SPM site with any 
    monitoring method for a period of 3 years following the promulgation 
    date of the NAAQS.
        Numerous commenters opposed the proposed 3-year exclusion of SPM 
    data as a basis for NAAQS violations, noting that all measured 
    violations from all monitors should be used for nonattainment 
    designations. Other commenters supported the exclusion, suggesting that 
    SPM data should always be considered exploratory in nature and should 
    remain exempt from inclusion in regulatory data bases.
        EPA has revisited its position on SPMs in light of these comments. 
    In order to encourage the deployment of SPMs, EPA has decided to 
    continue to provide States with the flexibility to exempt SPM data from 
    regulatory use, but limit the period of the moratorium to the first 2 
    complete calendar years of operation of a new SPM. Given the currently 
    limited amount of PM2.5 data and the complexity of the 
    PM2.5 air quality problem, the Agency feels that this 
    approach still provides a significant incentive for States to engage in 
    additional monitoring and thereby collect data that would supplement 
    the data collected at SLAMS sites. This can be very helpful for 
    establishing an optimum network design, for a better understanding of 
    the impacts of specific emission sources, and for other planning 
    purposes. If a monitoring site satisfies all applicable part 58 
    requirements including use of reference or equivalent methods, meeting 
    siting criteria, and other requirements as explained in Sec. 58.14 and 
    it continues to collect data beyond the first 2 complete calendar years 
    of its operation, the data from such SPM sites would then be generally 
    eligible for comparisons to the NAAQS. One exception is when a 
    monitoring agency intends to evaluate a special situation which is not 
    representative of population-oriented monitoring. In this case, the 
    data from the special purpose monitor would not be used for comparison 
    to the PM2.5 standards. A second exception is when the 
    agency intends to evaluate a unique impact area that represents a small 
    spatial scale (micro or middle). In this case, the site would only be 
    eligible for comparison to the 24-hour NAAQS. Although SPM data will be 
    exempt from regulatory use during the 2-year moratorium, EPA emphasizes 
    that SPM data should nevertheless be considered in the State's PM 
    monitoring network description and in the design of its overall SLAMS 
    network. Moreover, SPM sites reporting values greater than the level of 
    a NAAQS should be considered during the annual network review in 
    accordance with Sec. 58.25, and summary data from SPM sites must be 
    included in the annual State Air Monitoring report described in 
    Sec. 58.26.
    
    E. Section 58.15 - Designation of Monitoring Sites
    
        The proposed monitoring regulations defined categories of sites 
    that would be eligible for comparisons to the annual or 24-hour NAAQS. 
    This included certain sites that could be used for comparison to both 
    standards (B sites), to only the daily standard (D sites) and certain 
    special purpose monitors (O sites) that potentially would not be used 
    for comparison to any standard. Due to significant concern regarding 
    the complexity of implementing those concepts to handle a small number 
    of unique monitoring situations, the final rule has eliminated the 
    coding of sites as type B, D, and O sites. Therefore, Sec. 58.15 has 
    been deleted in its entirety. The principal reasons also include the 
    emphasis on community-oriented monitors, the new terminology and 
    modified approach associated with CMZs, and more precise descriptions 
    of SLAMS and SPMs. The final rule provides a more streamlined and 
    simplified monitoring approach that retains the basic community average 
    air quality exposure tenets of the PM2.5 annual NAAQS and, 
    as proposed,
    
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    recognizes that population-oriented hot spot monitoring may be more 
    reflective of situations applicable to the purposes of the 24-hour 
    PM2.5 standard.
        The changes to community monitoring and site categorization are 
    well integrated. EPA agrees with public comment that the proposed 
    spatial averaging approach may not have been properly communicated by 
    suggesting that it allowed averaging of monitors across widely 
    disparate areas not reflective of average community-oriented exposure 
    and a homogeneous emission source mix. EPA believes that by clarifying 
    the criteria that determine which monitors can be averaged together 
    (i.e., monitors in areas affected by similar emission sources), along 
    with emphasizing that well sited community-oriented monitors should be 
    used, environmental equity concerns and related issues are effectively 
    addressed. First, a single SLAMS or SPM that adequately represents a 
    local area can reflect its own community monitoring area. If its annual 
    average concentrations are more than 20 percent higher than the 
    surrounding average PM2.5 air quality, it would not be 
    eligible to be averaged in with the surrounding sites of the larger 
    geographic domain. In addition, unique population-oriented hot spot 
    impact sites are not eligible for comparison to the annual 
    PM2.5 NAAQS and are only eligible for comparison to the 24-
    hour NAAQS. Additional details about CMZs are provided later.
    
    F. Section 58.20 - Air Quality Surveillance: Plan Content
    
        Although no comments were received on proposed changes to this 
    section, the title was inadvertently stated as Plan Control; this title 
    has been changed to Plan Content. In addition, the first sentence of 
    paragraph (d) has been changed by deleting the words ``section 2.8 of'' 
    and the words ``as well as the minimum requirements for networks of 
    SLAMS stations for PM2.5 described in section 2.8.2 of 40 
    CFR part 58, Appendix D.'' Since Sec. 58.20 requires an annual review 
    of the air quality surveillance system for all SLAMS, these changes 
    were instituted for clarity. The reference to PM2.5 in the 
    third sentence of Sec. 58.20 was retained to ensure that the review 
    includes the unique requirements of the PM2.5 monitoring 
    network.
        The proposal indicated that a detailed Particulate Matter 
    Monitoring Plan (see Sec. 58.1, as proposed) must be prepared by the 
    affected air pollution control agency and submitted to EPA for 
    approval. This plan was designed to comprehensively describe the 
    Agency's PM2.5 and PM10 air quality surveillance 
    networks. Comments received noted that the term PM monitoring plan 
    could be confused with the network description required by Sec. 58.20. 
    Accordingly, EPA has replaced references to the ``PM Monitoring Plan or 
    monitoring plan'' in this final rule with references to the 
    ``particulate matter monitoring network description or PM monitoring 
    network description.'' The Agency notes, however, that the rule 
    published today requires a more expanded and comprehensive network 
    description for PM than has previously been required for other 
    networks. Therefore, a new paragraph (f) has been added to Sec. 58.20 
    to delineate the requirements for PM monitoring network descriptions. 
    According to Sec. 58.20(e), as amended, this network description must 
    be submitted to the EPA Regional Administrator for approval.
        To ensure opportunities for public review and inspection of the 
    monitoring network, States must maintain information and records on 
    such items as the station location, monitoring objectives, spatial 
    scale of representativeness, optional CMZs, and schedule for completion 
    of the network. Such information and records are included in a State's 
    PM monitoring network description. The PM monitoring network 
    description prepared by States and submitted to EPA for approval should 
    be viewed as a long-term network of SLAMS and NAMS sites that meet the 
    variety of monitoring objectives specified in 40 CFR part 58, Appendix 
    D of these regulations. These objectives include determining compliance 
    with air quality standards, developing appropriate control strategies 
    as required, and preparing short- and long-term air quality trends. 
    However, modifications to the network can be made without a formal SIP 
    revision thus encouraging States to make any needed yearly (or 
    alternate schedule as determined by the EPA Regional Administrator) 
    changes to the SLAMS network to make it more responsive to data needs 
    and resource constraints. In order to avoid making major modifications 
    to the PM monitoring network description during the annual review, the 
    detailed network, including monitoring planning areas and CMZs, should 
    be carefully planned and designed to provide a stable base of air 
    quality data. Since no formal SIP revision (that entails Federal 
    Register proposal and public comment) is required for the PM monitoring 
    network description revisions, EPA encourages public involvement in the 
    review of a State's PM monitoring network description particularly when 
    the spatial averaging monitoring approach is selected for comparisons 
    to the annual standard.
    
    G. Section 58.23 - Monitoring Network Completion
    
        EPA proposed that the PM networks would be expected to be completed 
    within 3 years of the effective date of promulgation. While new 
    PM2.5 networks are developed, reductions in existing 
    PM10 networks would be considered. The proposal stated that 
    during the first year, a minimum of one monitoring planning area per 
    State would be required to have core PM2.5 SLAMS. This area 
    would be selected by the State according to the likelihood of observing 
    high PM2.5 concentrations and according to the size of the 
    affected population. In addition, one PM2.5 site was 
    proposed to be collocated at one PAMS site in each of the PAMS areas. 
    During the second year, all other core population-oriented 
    PM2.5 SLAMS, and all core background and transport sites, 
    were proposed to be fully operational. During the third year, any 
    additional required PM2.5 (non-core) SLAMS was proposed to 
    be fully deployed and all NAMS sites would be selected from core SLAMS 
    and proposed to EPA for approval.
        Several commenters discussed the proposed phase-in schedule. One 
    commenter supported an accelerated phase-in schedule, while other 
    commenters supported a longer phase-in period. Several State commenters 
    expressed reservations about their ability to meet the proposed phase-
    in schedule, due to limited resources and the unavailability of 
    monitoring equipment. One commenter felt that the phase-in should 
    require one core monitor in each of a few geographically diverse areas 
    per State, as this would provide more valuable information than only 
    one per MPA.
        As noted in the comments on 40 CFR part 58, Appendix D, a large 
    number of commenters cited the immediate need for an expansive 
    PM2.5 monitoring network to provide adequate monitoring data 
    to satisfy the monitoring objectives of the SLAMS network, in 
    particular, to provide 3 years of PM2.5 data in order to 
    make comparisons with the NAAQS. As noted in the discussion below on 
    resources and costs, the Agency's grant allocations for fiscal years 
    1997-1998 include significant resources to accelerate the 
    implementation schedule and increase the number of monitoring sites 
    included in today's final rule. In view of these actions, the Agency is 
    accelerating the SLAMS monitoring
    
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    network completion schedule to require at least one core monitor in 
    each MSA greater than 500,000 population plus one PM2.5 site 
    to be collocated with a PAMS site in each PAMS area and at least 2 
    additional SLAMS per State to be in operation by 1998; to require all 
    other required SLAMS including required regional transport and regional 
    background sites to be in operation by 1999; and to encourage all 
    additional sites (to complete the network) to be in operation by 2000. 
    In addition, the States should have at least one core SLAMS to be 
    deployed in all areas expected to have the potential for high 
    PM2.5 concentrations, in accordance with EPA guidance, to be 
    in operation by 1998 which will be supported with funding from EPA's 
    section 105 grant program.
    
    H. Section 58.25 - System Modification
    
        The preamble to the proposal noted that although no changes to the 
    regulatory language were proposed for this section, the annual 
    monitoring system modifications review must include changes to 
    PM2.5 site designations (e.g., NAAQS comparison sites), and 
    the number or boundaries of monitoring planning areas and/or spatial 
    averaging zones, now referred to as community monitoring zones. This 
    information is included for explanatory purposes only and does not 
    necessitate changes to the regulatory language.
    
    I. Section 58.26 - Annual State Monitoring Report
    
        Under the current regulations, States are required to submit an 
    annual SLAMS data summary report. EPA proposed that this report shall 
    be expanded to: (1) Describe the proposed changes to the State's PM 
    Monitoring Network Description, as defined in Sec. 58.20; (2) include a 
    new brief narrative report to describe the findings of the annual SLAMS 
    network review, reflecting within the year and proposed changes to the 
    State air quality surveillance system; and (3) provide information on 
    PM SPMs and other PM sites noted in the PM monitoring network 
    description regardless of whether data from the stations are submitted 
    to EPA (including number of monitoring stations, general locations, 
    monitoring objective, scale of measurement, and appropriate 
    concentration statistics to characterize PM air quality such as number 
    of measurements, averaging time, and maximum, minimum, and average 
    concentration). The latter is for EPA to ensure that a proper mix of 
    permanent and temporary monitoring locations are used and that 
    populated areas throughout the Nation are monitored, and to provide 
    needed flexibility in the State monitoring program.
        In addition, the proposed changes to the PM monitoring network 
    description included changes to existing PM networks. The proposed 
    changes to existing PM networks included modifications to the number, 
    size, or boundaries of MPAs or SAZ's, number and location of PM SLAMS; 
    number or location of core PM2.5 SLAMS; alternative sampling 
    frequencies proposed for PM2.5 SLAMS (including core 
    PM2.5 SLAMS and PM2.5 NAMS); core 
    PM2.5 SLAMS to be designated PM2.5 NAMS; and PM 
    SLAMS to be designated PM NAMS. SPM's with measured values greater than 
    the level of the NAAQS would become part of the SLAMS network. The 
    proposed changes would be developed in close consultation with the 
    appropriate EPA Regional Office and submitted to the appropriate 
    Regional Office for approval. The portion of the document pertaining to 
    NAMS would be submitted to the EPA Administrator (through the 
    appropriate Regional Office).
        Finally, as a continuation of current regulations, the States would 
    be required to submit the annual SLAMS summary report and to certify to 
    the EPA Administrator that the SLAMS data submitted are accurate and in 
    conformance with applicable part 58 requirements. Under the proposed 
    revisions, States would also be required to submit annual summaries of 
    SPM data to the EPA Regional Administrator for sites included in their 
    PM monitoring network description and to certify that such data are 
    similarly accurate and likewise in conformance with applicable part 58 
    requirements or other requirements approved by the EPA Regional 
    Administrator, if these data are intended to be used for SIP purposes. 
    All of the proposed changes described above did not receive substantive 
    comment and were retained in the final rule.
        During the first 3 years following promulgation, the proposal 
    stated that the State's PM monitoring description (changed to PM 
    monitoring network description) and any modifications of it would be 
    submitted to EPA by July 1 (starting on the year following 
    promulgation) or by alternate annual date to be negotiated between the 
    State and EPA Regional Administrator, with review and approval/
    disapproval by the EPA Regional Administrator was proposed to occur 
    within 45 days. After the initial 3-year period or once an SAZ (now 
    called CMZ) has been determined to be violating any PM2.5 
    NAAQS, then changes to a MPA would require public review and 
    notification to ensure that the appropriate monitoring locations and 
    site types are included.
        Several commenters addressed the requirements for the Annual State 
    Monitoring Report. Some commenters felt that the 45-day review was too 
    restrictive and should be extended to 60 days. Other commenters felt 
    that the annual review requirement was reasonable in the short-term, 
    but should be reconsidered after 3 years.
        In response to these comments, the Agency is extending the Regional 
    review period to 60 days. After the first 3 years, the required annual 
    review can be reconsidered and its schedule revised as determined by 
    the EPA Regional Administrator. As discussed earlier in this preamble, 
    EPA will entertain suggestions for modifications to the published 
    monitoring network requirements. States can request exemptions from 
    specific required elements of the network design (e.g., required number 
    of core SLAMS sites, other SLAMS sites, sampling frequency, etc.) 
    through the Annual Monitoring Report.
    
    J. Section 58.30 - NAMS Network Establishment
    
        The preamble to the proposal called for States to submit a NAMS 
    network description (which is to be derived from the core 
    PM2.5 SLAMS) of each State's SLAMS network to the EPA 
    Administrator (through the appropriate EPA Regional Office) within 6 
    months of the effective date of the final rule. At the same time, a 
    State's NAMS PM10 network must be reaffirmed if no changes 
    are made to the existing network and if changed must also be fully 
    described and documented in a submittal to the EPA Administrator 
    (through the appropriate EPA Regional Office). The proposed Sec. 58.34 
    stated that the NAMS Network completion shall be by 3 years after the 
    effective date of the final rule. This has not been changed in this 
    final rule. However, the proposed revisions to this section 
    inadvertently called for the PM2.5 network description to be 
    submitted 3 years after the effective date of promulgation. The final 
    rule has been changed to read July 1, 1998.
    
    K. Section 58.31 - NAMS Network Description
    
        The term spatial averaging zone was used in the proposed revisions 
    to this section. In the final rule, this term has been replaced by the 
    term community monitoring zone (CMZ).
    
    [[Page 38773]]
    
    L. Section 58.34 - NAMS Network Completion
    
        The preamble to the proposal called for changes to the NAMS 
    PM10 network to be completed by 1 year after the effective 
    date of the final rule and to the NAMS PM2.5 network to be 
    completed by 3 years after the effective date of the final rule. The 
    proposed rule incorrectly stated 6 months instead of 1 year for the 
    PM10 network to be completed. The final rule has been 
    changed to read 1 year after the effective date of these regulations 
    for PM10 and 3 years after the effective date of these 
    regulations for PM2.5.
    
    M. Section 58.35 - NAMS Data Submittal
    
        The proposed revision to this section added PM2.5 as an 
    additional indicator of PM to the list of pollutants that must submit 
    air quality data and associated information to the EPA Administrator as 
    specified in the AIRS Users Guide. This section is promulgated as 
    proposed.
    
    N. Appendix A - Quality Assurance Requirements for SLAMS
    
        1. Summary of proposal. The proposal addressed the fact that 
    enhanced QA and QC procedures were required in the areas of sampler 
    operation, filter handling, data quality assessment, and other 
    operator-related aspects of the PM2.5 measurement process. 
    These enhanced QA/QC procedures were necessary for meeting the data 
    quality objectives for ambient PM2.5 monitoring.
        Most operational QC aspects were specified in 40 CFR part 58, 
    Appendix A in general terms. However, for PM2.5, explicit, 
    more stringent, requirements were proposed for sample filter treatment-
    -including the moisture equilibration protocol, weighing procedures, 
    temperature limits for collected samples, and time limits for prompt 
    analysis of samples. Details concerning these operator-related 
    procedures were proposed to be published as a new section 2.12 of EPA's 
    Quality Assurance Handbook for Air Pollution Measurement Systems, 
    Volume II to assist monitoring personnel in maintaining high standards 
    of data quality.
        Procedures were proposed for assessing the resulting quality of the 
    monitoring data in 40 CFR part 58, Appendix A. Perhaps the most 
    significant new data quality assessment requirement proposed for 
    PM2.5 monitoring was the requirement that each 
    PM2.5 SLAMS monitor was to be audited at least six times per 
    year. This was the first time a requirement had been proposed to assess 
    the relative accuracy of the mass concentration measured by a PM SLAMS 
    monitor. Each of these six audits would have been performed by the 
    monitoring agency and would have consisted of concurrent operation of a 
    collocated reference method audit sampler along with the 
    PM2.5 SLAMS monitor. The data from these collocated audits 
    were proposed to have been used by EPA to assess the performance of the 
    PM2.5 SLAMS monitor and to identify reporting organizations 
    or individual sites that had abnormal bias or inadequate precision for 
    the year.
        Other data assessment requirements proposed for PM2.5 
    monitoring networks were patterned after the current requirements for 
    PM10 networks and were intended to supplement the audit 
    procedure. The proposal required PM2.5 network monitors to 
    be subject to precision and accuracy assessments for both manual and 
    automated methods, using procedures similar or identical to the current 
    procedures required for PM10 monitoring networks. Results of 
    the field tests performed by the monitoring agencies (including the 
    field tests) would have been sent to EPA. EPA then would have carried 
    out the specified calculations which would have become part of the 
    annual assessment of the quality of the monitoring data.
        Although the proposed QA requirements for PM2.5 would 
    have resulted in an increase in quality assessment requirement for PM 
    monitoring, the additional QA/QC checks would have incurred more cost 
    to the monitoring agency. Some of the proposed new QA/QC assessment 
    requirements would have somewhat overlapped the information provided by 
    other checks, such as the periodic flow rate checks and the use of 
    collocated samplers in monitoring networks.
        A revision to 40 CFR part 58, Appendix A, was also proposed to 
    provide for technical system audits to be performed by EPA at least 
    every 3 years rather than every year. This change to a less frequent 
    system audit schedule recognized the fact that for many well 
    established agencies, an extensive system audit and rigorous inspection 
    may not have been necessary every year. The determination of the extent 
    and frequency of system audits at an even lower frequency than the 
    proposed 3-year interval was being left up to the discretion of the 
    appropriate EPA Regional Office, based on an evaluation of the Agency's 
    data quality measures. This change would have afforded both EPA and the 
    air monitoring agencies flexibility to manage their air monitoring 
    resources to better address the most critical data quality issues.
        2. The PM2.5 QA system. Based upon public comments, the 
    Agency has reviewed 40 CFR part 58, Appendix A and re-evaluated several 
    aspects of the QA and QC quality control system used to assess the 
    particulate monitoring data. The requirements associated with the 
    PM10 QA system remained unchanged by these modifications. 
    Specifically for PM2.5, the major modifications include 
    focusing 80 percent of the QA resources to sites with concentrations of 
    greater than or equal to 90 percent of the annual PM2.5 
    NAAQS (or 24-hour NAAQS if that is affecting the area), increasing the 
    amount of collocated monitors to 25 percent of the total number of 
    SLAMS monitors within a reporting organization, and changing the FRM 
    audit procedures to an independent assessment of the bias of the 
    PM2.5 monitoring network. The FRM audits were reduced in 
    number to 25 percent of the SLAMS monitors at a frequency of 4 times 
    per year. All modifications are discussed in detail in the following 
    paragraphs.
        In response to comments that the proposed QA requirements were 
    inadequate, and in order to clarify the intent of the quality system, 
    EPA is incorporating the concept and definition of a quality system 
    into section 2, Quality System Requirements. EPA defines QA as an 
    integrated system of management activities involving planning, 
    implementation, assessment, reporting, and quality improvement to 
    ensure that a process, item, or service is of the type and quality 
    needed and expected by the customer. QC is defined as the overall 
    system of technical activities that measures the attributes and 
    performance of a process, item, or service against defined standards to 
    verify that they meet the stated requirements established by the 
    customer. A quality system is defined as a structured and documented 
    management system describing the policies, objectives, principles, 
    organizational authority, responsibilities, accountability, and 
    implementation plan of an organization for ensuring quality in its work 
    processes, products (items), and services. The quality system provides 
    the framework for planning, implementing, and assessing work performed 
    by the organization and for carrying out required QA and QC.
        The Agency used the data quality objective (DQO) process to 
    specifically develop the QA system for the new PM2.5 
    program. The DQO process is a systematic strategic planning tool based
    
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    on the scientific method that identifies and defines the type, quality, 
    and quantity of data needed to satisfy a specific use. Meeting the new 
    data quality objectives for ambient PM2.5 monitoring 
    requires a combination of QA and QC procedures to evaluate and control 
    data measurement uncertainty. For this reason, EPA has developed a 
    quality system specifically for PM2.5 which incorporates 
    procedures to quantify total measurement uncertainty, as it relates to 
    total precision and total bias, within the PM2.5 monitoring 
    network. In order to clarify the tools used in the QA system, the 
    Agency has included definitions in 40 CFR part 58, Appendix A. Total 
    bias is defined as the systematic or persistent distortion of a 
    measurement process which causes errors in one direction (i.e., the 
    expected sample measurement is different from the sample's true value). 
    Total precision is defined as a measure of mutual agreement among 
    individual measurements of the same property, usually under prescribed 
    similar conditions, expressed generally in terms of the standard 
    deviation. Accuracy is defined as the degree of agreement between an 
    observed value and an accepted reference value, accuracy includes a 
    combination of random error (precision) and systematic error (bias) 
    components which are due to sampling and analytical operations. The 
    Agency will use various QA tools to quantify this measurement 
    uncertainty; this includes collocation of monitors at various 
    PM2.5 sites, use of operational flow checks, and 
    implementation of an independent FRM audit.
        The measurement system represents the entire data collection 
    activity. This activity includes the initial equilibration, weighing, 
    and transportation of the filters to the sampler; calibration, 
    maintenance, and proper operation of the instrument; handling/placement 
    of the filters; proper operation of the instrument (sample collection); 
    removal/handling/transportation of the filter from the sampler to the 
    laboratory; weighing, storage, and archival of the sampled filter; and 
    finally, data analysis and reporting. Additional or supplemental 
    detailed quality assurance procedures and guidance for all operator-
    related aspects of the PM2.5 monitoring process will be 
    published as a new section 2.12 of EPA's Quality Assurance Handbook for 
    Air Pollution Measurement Systems, Volume II, Ambient Air Specific 
    Methods to assist monitoring personnel in maintaining high standards of 
    data quality.
        To clarify the requirements and guidance concerning the SLAMS 
    ambient air network, the Agency has developed Quality Assurance 
    Division (QAD) requirements documents, which are referenced in section 
    2.2. For simplification, the Agency has removed the list of pertinent 
    operational procedures from this section and has replaced the list with 
    the updated reference. In response to comments about potential 
    difficulties in following the requirements in ANSI E-4, EPA has instead 
    required quality assurance and control programs to follow the 
    requirements for quality assurance project plans contained in EPA 
    requirements for quality assurance project plans for environmental data 
    operations, EPA QA/R-5 an EPA QAD document.
        EPA received many comments on the proposed bimonthly audits for 
    each PM2.5 site as proposed in section 6.0 of Appendix A. 
    Commenters expressed concerns about the excessive burden the 
    requirement would put on State and local air pollution control 
    agencies, the length of time involved with the process, and the quality 
    control, reliability, and logistical aspects of a portable audit 
    device.
        Based upon these comments, the Agency re-assessed its position 
    concerning the number of sites and the frequency of audits that the 
    State and local agencies perform. The Agency feels that independent FRM 
    audits are essential to reaching the goal of the data quality 
    objectives for PM2.5 because these audits evaluate the total 
    bias for each designated PM2.5 Federal Reference and 
    Equivalent monitoring method within the monitoring network. Therefore, 
    the Agency has modified the proposed audit program to make it 
    independent and also to reduce the burden on State and local agencies. 
    Section 6.0 as proposed has been deleted, with remaining data quality 
    assessment requirements for PM2.5 included in section 3.5 of 
    40 CFR part 58, Appendix A. The resulting data will be assessed at 
    three distinct levels--single monitor level, reporting organization 
    level, and at a national level. Details of the assessment process will 
    be published in EPA's Quality Assurance Handbook for Air Pollution 
    Measurement Systems, Volume II, Ambient Air Specific Methods.
        Commenters endorsed the reduction in the frequency of systems 
    audits from every year to every 3 years as proposed in section 2.5. 
    Therefore, the requirement for a 3-year schedule for system audits 
    remains unchanged.
        3. Evaluation of measurement uncertainty. EPA received several 
    comments on the procedures used to address the quality assurance of the 
    data as proposed in section 3 of the Appendix. Commenters were 
    concerned about the limited resources available to properly comply with 
    all aspects of the proposed quality system. In the initial deployment 
    of the SLAMS PM2.5 network, special QA emphasis should be 
    placed on those sites likely to be involved in possible nonattainment 
    decisions. Once the initial attainment/nonattainment designations have 
    been made, the Agency recommends focusing 80 percent of the QA activity 
    (collocated monitors and FRM audits) at sites with concentrations 
    greater than or equal to 90 percent of the mean annual PM2.5 
    NAAQS (or 24-hour NAAQS if that is affecting the area); this percentage 
    will be 100 percent if all sites have concentrations above either 
    NAAQS. The remaining 20 percent of the QA activity would be at sites 
    with concentrations less than 90 percent of the PM2.5 NAAQS. 
    If an organization has no sites at concentration ranges greater than or 
    equal to 90 percent of the PM2.5 NAAQS, the Agency 
    recommends 60 percent of the QA activity be at sites among the highest 
    25 percent for all PM2.5 sites in the network. The Agency 
    understands the initial selection of sites will likely be subjective 
    and based upon the experience of State and local organizations.
        Other data assessment requirements for PM2.5 monitoring 
    networks are patterned after the current requirements for 
    PM10 networks and are intended to quantify the monitoring 
    network's total precision and bias. PM2.5 network monitors 
    will be subject to performance assessments for both manual and 
    automated methods, using procedures similar or identical to the current 
    procedures required for PM10 monitoring networks. The Agency 
    received several comments describing incentives for acceptable 
    performance in the QA field. In response to these concerns, EPA intends 
    to reduce the QA burden in accordance with network monitoring and 
    acceptable performance of the QA program. Based upon EPA's yearly data 
    quality assessment, acceptable performance could result in a reduction 
    in the frequencies of QA/QC requirements. Additional details for the 
    incentive program will be provided in the Quality Assurance Handbook 
    for Air Pollution Measurement Systems, Volume II, Ambient Air Specific 
    Methods.
        The Agency believes that to develop a national, consistent 
    monitoring network with quantifiable data quality, a quality system 
    must be developed that permits maximum flexibility yet ensures that the 
    measurement uncertainty is known and under control. For this
    
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    reason, the Agency has removed the requirement in section 3.3.5 that 
    the paired monitors have the same FRM or equivalent sampler designation 
    number, but now formalizes the 6-day sampling schedule for collocated 
    monitors into the regulation; this was previously described in 
    guidance.
        With regard to the requirements for evaluating measurement 
    uncertainty, the estimates of bias within the monitoring network will 
    be evaluated with flow audits (section 3.5.1) and independent FRM 
    audits (see comments concerning section 3.5.3). An audit of the 
    operational flow rate determines bias as performed by the local 
    operators of manual methods for PM2.5 with each sampler each 
    calendar quarter. Using a flow rate transfer standard, each sampler 
    will be audited at its normal operating flow rate. The percent 
    differences between the standard and sampler flow rates will be used to 
    evaluate instrument-specific bias.
        Specifically, for Federal Reference and Equivalent automated 
    methods, an additional assessment of the precision will consist of a 
    one-point precision check performed at least once every 2 weeks on each 
    automated analyzer used to measure PM2.5. This precision 
    check is performed by checking the operational flow rate of the 
    analyzer, using a procedure similar to that currently used for 
    PM10 network assessments. In addition, an alternative 
    procedure may be used where, under certain specific conditions, it is 
    permissible to obtain the precision check flow rate data from the 
    analyzer's internal flow meter without the use of an external flow rate 
    transfer standard. This alternative procedure is also made applicable 
    to PM10 methods.
        With regard to the proposed requirements in section 3.5.2, 
    (Measurement of precision using collocated procedures for automated and 
    manual methods of PM2.5) several commenters felt that 
    invalid data or data of questionable quality should not be a part of 
    the data base, since the general public and many end-users of the data 
    such as consultants and modelers do not always make distinctions about 
    data. Data reporting requirements specify that all valid monitoring 
    data be reported to AIRS. EPA believes that the requirement contained 
    in section 4.1 to report all QA/QC measurements including results from 
    invalid tests is necessary to fully assess the performance of reporting 
    organizations and to allow EPA to recommend appropriate corrective 
    actions. Such data will be flagged so that it will not be utilized for 
    quantitative assessments of precision, bias, and accuracy. EPA also 
    received many comments on the use of collocated samplers to assess 
    precision. Most of these comments advocated an increase in the number 
    of collocated monitors as an alternative to reduce the burden of the 
    independent audit system. Based upon these comments, EPA has reassessed 
    its position on the number of collocated monitors and now requires 25 
    percent of the total number of monitors for each designated Federal 
    Rand Equivalent Method within a reporting organization to be 
    collocated. To further assess the total precision and bias of the 
    monitoring network, half of the collocated monitors for each designated 
    Federal Reference and Equivalent Method must be collocated with a 
    Federal Reference Method (FRM) designated monitor and half must be 
    collocated with a monitor of the same designated method type as the 
    primary monitor. An example is shown in Table A-2 in 40 CFR part 58, 
    Appendix A.
        The Agency received numerous comments concerning the burden of the 
    proposed FRM audit procedures for PM2.5 (section 3.5.3), 
    which consisted of having every site audited six times each year with a 
    portable FRM audit sampler. In response to these comments, EPA has 
    reduced the number of audits to 25 percent of the total number of SLAMS 
    PM2.5 sites to be audited 4 times each year. In addition, 
    EPA has reduced the burden of the State and local agencies 
    responsibility for implementing the audits by providing access to the 
    existing EPA National Performance Audit Program (NPAP) or other 
    comparable programs. The details concerning the assessment of the 
    resulting data will be published in EPA's Quality Assurance Handbook 
    for Air Pollution Measurement Systems, Volume II, Ambient Air Specific 
    Methods.
        4. Reporting requirements. EPA received several comments concerning 
    the adequacy of QA reporting requirements (section 4). The Agency has 
    addressed these comments by strongly encouraging earlier QA data 
    submittal in order to assist the State and local agencies in 
    controlling and evaluating the quality of the ambient air SLAMS data.
        5. Data quality assessment. In response to several comments 
    concerning the adequacy of the QA data assessment procedures for the 
    PM2.5 program, including parts of proposed section 6.0, EPA 
    developed a new section 5.5 to consolidate and simplify the procedures 
    and calculations for the precision, accuracy, and bias measurements 
    used to quantify PM2.5 data quality. The quality assurance 
    system has been nested in such a manner that will allow for the 
    assessment of total measurement bias and precision, as well as portions 
    of the measurement system (i.e. field operations, laboratory 
    operations, etc.). Four distinct quality control checks and audits are 
    implemented to evaluate total measurement uncertainty: (1) Determine 
    instrument accuracy and instrument bias from flow rate audits, (2) 
    determine precision from collocated monitors where the duplicate 
    monitor has the same method designation, (3) determine a portion of the 
    measurement bias from collocated monitors where the duplicate sampler 
    is an FRM device, and (4) determine total measurement bias from FRM 
    audits. This design will allow for early identification of data quality 
    issues in the measurement phases (field/laboratory operations) where 
    they may be occurring and therefore, effective implementation of 
    corrective actions.
        6. FRM audit requirements. The Agency received many comments 
    concerned with the burden the proposed FRM audit system (the deleted 
    Section 6: Annual Operational Evaluation of PM2.5 Methods) 
    would put upon the individual State and local air pollution agencies. 
    Based upon the numerous comments, the Agency has re-assessed its 
    position concerning the audit system. The Agency reduced this burden by 
    providing the State and local agencies the flexibility to access the 
    existing NPAP program or comparable program, additionally reducing the 
    burden to 25 percent of the total number of SLAMS PM2.5 
    sites each year, and reducing the frequency of the audits to 4 per 
    year. EPA has removed section 6.0 from the regulations and incorporated 
    the appropriate information into other sections within 40 CFR part 58, 
    Appendix A. Additional information will be provided in the Quality 
    Assurance Handbook for Air Pollution Measurement Systems, Volume II, 
    Ambient Air Specific Methods.
    
    O. Appendix C - Ambient Air Quality Monitoring Methodology
    
        EPA proposed that 40 CFR part 53, subpart C, be amended to allow 
    the use of certain PM10 monitors as surrogates for 
    PM2.5 monitors for purposes of demonstrating compliance with 
    the NAAQS. The proposal further stated however, following the 
    measurement of a PM10 concentration higher than the 24-hour 
    PM2.5 standard or an annual average concentration higher 
    than the annual average PM2.5 standard, the PM10 
    monitor would have to be replaced with a PM2.5 monitor. In 
    the proposal of Appendix C, EPA also discussed the use of several types 
    of PM2.5 samplers at a SLAMS that are not designated as a
    
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    reference or equivalent method under 40 CFR part 53. First, EPA 
    proposed the use of certain nonreference/nonequivalent PM2.5 
    methods that could be used at a particular SLAMS site to make 
    comparisons to the NAAQS if it met the basic requirements of the test 
    for comparability to a reference method sampler for PM2.5, 
    as specified of 40 CFR part 53, subpart C in each of the four seasons 
    of the year at the site at which it is intended to be used. A method 
    that meets this test would then be further subjected to the operating 
    precision and accuracy requirements specified in the proposed Appendix 
    A to 40 CFR part 53, at twice the normal evaluation interval. A method 
    that meets these proposed requirements would not become an equivalent 
    method, but the method could be used at that particular SLAMS site for 
    any regulatory purpose. Second, EPA discussed the use of CAC methods 
    described in Sec. 58.13(f) which are intended to supplement a reference 
    or equivalent manual method at certain SLAMS, so that the manual method 
    could reduce its sampling frequency from every day to once in 3 days. 
    In addition, the proposed Appendix C clarifies that the monitoring data 
    obtained with CAC methods would be restricted to use for the purposes 
    of the proposed Sec. 58.13(f) and would not be used for making 
    comparisons to the NAAQS. Finally, the proposal also described samplers 
    for fine particulate matter used in the IMPROVE network (hereafter 
    termed IMPROVED samplers) and clarified that IMPROVE samplers, although 
    not designated as equivalent methods, could be used in SLAMS for 
    monitoring regional background concentrations of fine particulate 
    matter.
        Some commenters questioned the proposed use of PM10 
    samplers as substitutes for PM2.5 samplers to satisfy 
    requirements for PM2.5 SLAMS monitoring. EPA reassessed the 
    logic behind this proposal and agreed with commenters that substitute 
    samplers should not be allowed. In order for a PM10 sampler 
    to be a substitute PM2.5 sampler, the annual average 
    PM10 would have to be less than 15 g/m3 
    and the annual maximum 24-hour PM10 would have to be less 
    than 65 g/m3. This situation would not be 
    representative of community-oriented monitoring, would only exist at a 
    few rural locations and would not even provide useful information about 
    PM2.5 background concentrations; therefore EPA has deleted 
    this provision from Appendix C.
        Appendix C is being amended to add a new section 2.4 continuing 
    provisions that allow the use of a PM2.5 method that had not 
    been designated as a reference or equivalent method under 40 CFR part 
    53 at a SLAMS under special conditions. Such a method will be allowed 
    to be used at a particular SLAMS site to make comparisons to the NAAQS 
    if it meets the basic requirements of the test for comparability to a 
    reference method sampler for PM2.5, as specified in 40 CFR 
    part 53, subpart C, in each of the four seasons of the year at the site 
    at which it is intended to be used. A method that meets this test will 
    then be further subjected to the operating precision and accuracy 
    requirements specified in 40 CFR part 53, Appendix A, at twice the 
    normal evaluation interval. A method that meets these requirements will 
    not become an equivalent method, but can be used at that particular 
    SLAMS site for any regulatory purpose. The method will be assigned a 
    special method code, and data obtained with the method will be accepted 
    into AIRS as if they had been obtained with a reference or equivalent 
    method. This provision will allow the use of non-conventional 
    PM2.5 methods, such as optical or open path measurement 
    methods, which would be difficult to test under the equivalent method 
    test procedures proposed for 40 CFR part 53.
        In addition, Appendix C is being amended to add a new section 2.5 
    to clarify that CAC methods for PM2.5 approved for use in a 
    SLAMS under new provisions in Sec. 58.13(f) will not become de facto 
    equivalent methods as proposed. This applies to methods that have not 
    been designated equivalent or do not satisfy the requirements of 
    section 2.4 previously described. In response to recommendations that 
    IMPROVE samplers be allowed for use at core background and core 
    transport sites, EPA is revising section 2.9 to define IMPROVE samplers 
    for fine particulate matter and clarify that IMPROVE samplers, although 
    not designated as equivalent methods, could be used in SLAMS for 
    monitoring regional background and regional transport concentrations of 
    fine particulate matter.
        Finally, minor changes are being made to section 2.7.1 to update 
    the address to which requests for approval for the use of methods under 
    the various provisions of Appendix C should be sent, and section 5 to 
    add additional references.
    
    P. Appendix D - Network Design For State and Local Air Monitoring 
    Stations (SLAMS), National Air Monitoring Stations (NAMS) and 
    Photochemical Assessment Monitoring Stations (PAMS)
    
        1. Section 2.8.1 - Specific design criteria for PM2.5. 
    The proposed regulation contained language regarding the implementation 
    of spatial averaging through the design of PM2.5 monitoring 
    networks. MPAs and SAZs were introduced to conform to the population-
    oriented, spatial averaging approach taken in the proposed 
    PM2.5 NAAQS under 40 CFR part 50. While this proposed 
    approach is more directly related to the epidemiological studies used 
    as the basis for the proposed revisions to the particulate matter 
    NAAQS, it recognized that the use of MPAs and SAZs introduced greater 
    complexity into the network design process and the comparison of 
    observed values to the level of the PM2.5 annual NAAQS.
        A great number of comments were received concerning the 
    communication and complexity of spatial averaging, the selection of 
    monitors, and the need for providing flexibility in specifying network 
    designs and spatial averaging given that the nature and sources of fine 
    particles vary from one area to another.
        In response to concerns about the implementation and communication 
    of spatial averaging, EPA is clarifying the requirement for SAZs by 
    changing some terminology. EPA is also making it clear that the annual 
    mean PM2.5 from a single properly sited monitor that is 
    representative of community-wide exposures or an average of annual mean 
    PM2.5 concentrations produced by one or more of such 
    monitors that meet siting requirements and other constraints as set 
    forth in this rulemaking can be compared to the PM2.5 annual 
    standard. Specifically, this rule indicates that comparisons to the 
    annual PM2.5 standard can be made through the use of 
    individual monitors or the annual average of monitors in specific CMZs. 
    Community-oriented monitors should be used for these comparisons. This 
    approach will provide State and local agencies with additional 
    flexibility in defining community-wide air quality and in designing 
    monitoring networks. The annual average PM2.5 concentration 
    from one or more monitoring sites within a CMZ may be averaged to 
    produce an alternative indicator of annual average community-wide air 
    quality. However, the criteria for establishing CMZs have been modified 
    (compared to the previous SAZs) so that initial monitors will be 
    located in those
    
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    areas expected to have the highest community-oriented concentrations. 
    It should be noted that many of the sites meeting the siting, 
    monitoring methodology, and other monitoring requirements in 40 CFR 
    part 58 include population-oriented SPMs and industrial monitors.
        The eligible core monitors in a CMZ still must be properly sited 
    and meet the constraints specified in section 2.8.1.6 of 40 CFR part 
    58, Appendix D. The term SAZ has been replaced with CMZ and zone 
    throughout Appendix D. If the State chooses to make comparisons to the 
    annual PM2.5 NAAQS directly with individual monitors that 
    use the siting requirements of section 2.8.1.6.3 of 40 CFR part 58, 
    Appendix D then it is not required to perform the analyses needed to 
    establish a CMZ. A State still would be expected to justify that the 
    site meets the specified siting requirements and is representative of 
    community-wide exposures. Then it would not be expected, apriori, to 
    define the boundaries of zones within which the monitoring data would 
    be averaged. This section, that was proposed as ``Monitoring Planning 
    Areas and Spatial Averaging Zones,'' has been retitled as ``Specific 
    Design Criteria for PM2.5.''
        2. Section 2.8.1.3 - Core monitoring stations for PM2.5. 
    The proposed regulations described requirements for the numbers of 
    SLAMS sites including core SLAMS. To provide a minimal PM2.5 
    network in all high population areas for protection of the annual and 
    24-hour PM NAAQS, each required MPA was proposed to have at least two 
    core monitors. The new core monitoring locations would be an important 
    part of the basic PM-fine SLAMS regulatory network. These sites are 
    intended to primarily reflect community-wide air pollution in 
    residential areas or where people spend a substantial part of the day. 
    In addition to the population-oriented monitoring sites, core monitors 
    would also be established for regional background and regional 
    transport monitoring.
        To permit interface with measurements of ozone precursors and 
    related emission sources that may contribute to PM2.5, an 
    additional core monitor collocated at a PAMS site was proposed to be 
    required in those MSAs where both PAMS and PM2.5 monitoring 
    are required. The core monitor to be collocated at a PAMS site would be 
    considered to be part of the MPA PM2.5 SLAMS network and 
    would not be considered to be a part of the PAMS network as described 
    in section 4 of 40 CFR part 58, Appendix D. Each SAZ in a required MPA 
    was proposed to have at least one core monitor; SAZs in optional MPAs 
    were proposed to have at least one core monitor; and SAZs were proposed 
    to have at least one core site for every four SLAMS.
        Several commenters addressed issues related to the number of core 
    SLAMS, population-oriented SLAMS, and other SLAMS. Numerous commenters 
    supported increasing the number of stations while few supported 
    decreasing the number of stations. In addition, some commenters 
    addressing the issue of spatial averaging also suggested that more 
    monitors might be needed to address less populated areas and areas near 
    hot spots. A few commenters suggested that large States or geographic 
    areas might require several regional background or regional transport 
    sites and that increased monitoring in rural or remote areas would be 
    needed to establish naturally occurring concentrations produced by 
    biogenic sources.
        EPA agrees with commenters that more monitors are needed to address 
    smaller communities, larger MSAs with several source categories of fine 
    particulate emissions, to address coverage for multiple sites in 
    optional CMZs, regional transport monitoring upwind of the major 
    population centers in the country, and additional sites near 
    population-oriented pollution hot spots. Accordingly, EPA has revised 
    the regulation to increase the number of required core SLAMS and other 
    SLAMS. These changes result in approximately 220 more required sampling 
    sites, nationally, as compared to the number proposed (850 versus 629). 
    At least one core SLAMS is now required in any MSA with a population 
    greater than 200,000. EPA is requiring additional sites in all MSAs 
    with population greater than 1 million in accordance with the following 
    table:
    
       Table 1.--Required Number of Core SLAMS According to MSA Population  
    ------------------------------------------------------------------------
                                                Minimum Required No. of Core
                  MSA Population                           Sitesa           
    ------------------------------------------------------------------------
    >1 M                                        3                           
    ------------------------------------------------------------------------
    >2 M                                        4                           
    ------------------------------------------------------------------------
    >4 M                                        6                           
    ------------------------------------------------------------------------
    >6 M                                        8                           
    ------------------------------------------------------------------------
    >8 M                                        10                          
    ------------------------------------------------------------------------
    aCore SLAMS at PAMS are in addition to these numbers.                   
    
    This section, which was proposed as section 2.8.2.1, has been 
    renumbered as section 2.8.1.3.
        As discussed in Sec. 58.13, Operating Schedule, all 
    PM2.5 SLAMS are required to have a minimum operating 
    schedule of once every 3 days, except for a subset of at least two core 
    PM2.5 sites per MSA with population greater than 500,000 and 
    one site in each PAMS area that is required to conduct daily sampling 
    as proposed.
        3. Section 2.8.1.4 - Other PM2.5 SLAMS locations. EPA is 
    retaining the requirement to have a minimum of one regional background 
    and one regional transport site per State and recognizing the need for 
    exceptions when appropriate, particularly in small States; however, 
    these sites are no longer designated as core SLAMS. EPA also is 
    requiring additional SLAMS monitors based upon the State population 
    less the population in all required MSA monitoring areas (i.e., MSAs 
    greater than 200,000), to provide population coverage throughout the 
    State, particularly in States with fewer urbanized areas. For this 
    remaining population there should be one additional SLAMS per 200,000 
    population. These additional sites may be used to satisfy any SLAMS 
    objective anywhere in the State including population areas (large 
    cities or small towns) or regional transport in rural areas. The 
    requirement for the additional SLAMS is over and above the requirement 
    for one regional background and regional transport site per State as 
    mentioned above. This section, which was proposed as section 2.8.2.2, 
    has been renumbered as section 2.8.1.4. For planning purposes, EPA 
    expects that the total number of sites in a mature, fully-developed 
    PM2.5 network will exceed these required minimums. The 
    projected total number is 1,500 sites, as compared to the proposed 
    1,200 sites. This is an increase of 25 percent compared to the number 
    proposed and is based on the recognized need for more monitoring in 
    smaller communities, more monitors in larger MSAs with several source 
    categories of fine particulate emissions, the possible need for 
    multiple sites in optional CMZs, the need to support regional transport 
    monitoring upwind of the major population centers in the country, and 
    the need for additional sites near pollution hot spots.
        4. Section 2.8.1.5 - Additional PM2.5 Analysis 
    Requirements. EPA recognizes the need for chemical speciation of 
    particulate matter. Such data are needed to characterize 
    PM2.5 composition and to better understand the sources and 
    processes leading to elevated PM2.5 concentrations. Because 
    of the costs associated with conducting filter analysis on a routine 
    basis, however the
    
    [[Page 38778]]
    
    proposal only required filters to be archived so they would be 
    available for subsequent chemical analysis on an as needed basis. EPA 
    recognizes that there is a need for speciation and other specialized 
    monitoring efforts that were not specifically required by the proposed 
    rule. Accordingly, EPA intended to give these PM monitoring efforts 
    high priority in its section 105 grants program.
        Many commenters supported the concept of chemical speciation, 
    noting that speciation was essential for identifying all of the 
    components of fine particles and developing control strategies. Some 
    commenters recommended that the program be conducted under national or 
    regional supervision to ensure consistency and reduce costs, and that 
    routine chemical analyses are conducted in a centralized laboratory. 
    EPA also received several comments on the proposed archival 
    requirements. Some commenters suggested that if chemical speciation was 
    required, the filter archival requirement could be eliminated. Other 
    commenters noted that the long-term archival requirements placed 
    additional resource burdens on agencies, and that possible filter 
    degradation and/or bias could result from archiving samples prior to 
    analysis.
        Based on these comments, the Agency reassessed its position 
    concerning chemical speciation as an optional part of the 
    PM2.5 monitoring program. Although speciation is resource 
    intensive, EPA believes that its overall value in satisfying control 
    strategy and other data needs justifies the added expense. Chemical 
    speciation is critically important for the implementation efforts 
    associated with air quality programs. Specific subject areas supported 
    by chemical speciation include source attribution analysis (i.e., 
    determining the likely mix of sources impacting a site) and emission 
    inventory and air quality model evaluation. Emission inventory and 
    modeling tools are used to develop sound emission reduction strategies. 
    Speciated data are especially critical for air quality model evaluation 
    since resolved chemical measurements provide greater assurance that 
    acceptable model behavior results from appropriate process 
    characterization rather than through the collective effect of 
    compensating errors. Speciated data provide greater ability to identify 
    the causes of poor model performance and implement corrective actions. 
    After strategies are developed and controls are implemented, chemically 
    resolved PM2.5 data provide a tracking and feedback 
    mechanism to assess the effectiveness of controls and, if necessary, 
    provide a basis for adjustment. Chemical speciation provides an 
    additional quality check on data consistency since a basis for 
    comparing the sum of individual components (i.e., speciated data) with 
    total mass measurement is available. Also, speciated data supports the 
    forthcoming regional haze program by providing a basis for developing 
    reliable estimates of seasonal and annual average visibility 
    conditions. Chemically resolved data should provide more complete data 
    for future health studies. EPA believes that speciation should be part 
    of the final PM2.5 monitoring program due to the collective 
    value of speciation. However, the Agency also believes that flexibility 
    must be provided to the States to tailor efforts to the needs of 
    specific areas. Based on public comments, a minimum chemical speciation 
    trends network will be required to address the needs discussed above.
        Based on this requirement to collect speciated data at NAMS sites, 
    EPA is eliminating the requirement to archive filters from NAMS. 
    However, all other SLAMS sites will still be required to archive 
    filters for a minimum of 1 year after collection. Access to these 
    archived filters for chemical speciation would be helpful in cases 
    where: (1) Exceedances or near exceedances of the standard have 
    occurred and additional information and data are needed to determine 
    more precisely possible sources contributing to the exceedances or high 
    concentrations, and (2) certain sites may have shown marked differences 
    in air quality trends at the local or national level for no apparent 
    reason and analysis of filters from more than one site might be 
    required to determine the reason(s) for the differences. EPA intends to 
    assign a high priority to this program through its section 105 grant 
    allocation program and will issue guidance describing the monitoring 
    methods and scenarios under which speciation should be performed. The 
    FRM described in 40 CFR part 50, Appendix L, is finalized as a single-
    filter based method. Therefore, supplementary monitoring equipment 
    that, for example, permits the use of additional filter media will be 
    needed to perform the appropriate speciation. Additional details on the 
    monitoring methodology for performing speciation and related 
    information on filter handling and/or storage will be addressed in 
    forthcoming EPA guidance.
        EPA is now instructing the States to initiate chemical speciation 
    in accordance with forthcoming EPA guidance at PM2.5 core 
    sites collocated at approximately 25 PAMS sites and at approximately 25 
    other core sites for a total of approximately 50 sites nationwide. 
    These sites would be selected as candidates for future NAMS 
    designation. Depending on available resources, chemical speciation 
    could be expanded to additional sites in the second and third years. 
    The requirement to collect speciated data will be reexamined after 5 
    years of data collection. Based on this review, the EPA Administrator 
    may exempt some sites from collecting speciated data. At a minimum, 
    chemical speciation will include analysis for metals and other 
    elemental constituents, selected anions and cations, and carbon.
        EPA recognizes that advantages related to consistency, quality 
    assurance and scales of economy would result from using centralized 
    laboratories for conducting chemical analyses. However, EPA is 
    concerned about the available laboratory capacity for meeting the needs 
    of a national PM2.5 speciation network. Several options are 
    under consideration that include developing new central and regional 
    laboratories and exploring the use of existing federal and State 
    facilities. This section, which was proposed as section 2.8.2.4, has 
    been renumbered as section 2.8.1.5.
        5. Section 3.7.6 - NAMS speciation. Consistent with the previous 
    discussion on speciation, the requirement to establish a subset of 
    approximately 50 NAMS sites for routine speciation is described in a 
    new section 3.7.6 of 40 CFR part 58, Appendix D. The approximately 50 
    sites will include the ones collocated at PAMS and approximately 25 
    other sites to be selected by the EPA Administrator, in consultation 
    with the Regional Administrators and the States. After 5 years of data 
    collection, the EPA Administrator may exempt some sites from collecting 
    speciated data. The number of NAMS sites at which speciation will be 
    performed each year and the number of samples per year will be 
    determined in accordance with EPA guidance. The subsequent sections of 
    section 3.7 have been renumbered accordingly.
    
    Q. Appendix E - Probe and Monitoring Path Siting Criteria for Ambient 
    Air Quality Monitoring
    
        The proposed revisions to this Appendix consisted of relatively 
    minor changes in the siting criteria to expand the requirements to 
    include PM2.5. Minor changes were made to the example 
    monitoring location in section 8.1 of the proposed revisions to 40 CFR 
    part 58, Appendix E, to replace ``mid-
    
    [[Page 38779]]
    
     town Manhattan in New York City'' with ``central business district of 
    a Metropolitan area.''
    
    R. Appendix F - Annual Summary Statistics
    
        A new section was proposed to be added to 40 CFR part 58, Appendix 
    F, to include annual summary statistics for PM2.5. No 
    changes were made to the proposed revisions.
    
    S. Review of Network Design and Siting Requirements for PM
    
        1. PM10. The network design and siting requirements for 
    the annual and 24-hour PM10 NAAQS will continue to emphasize 
    identification of locations at maximum concentrations. The 
    PM10 network itself, however, will be revised because the 
    new PM2.5 standards will likely be the controlling standards 
    in most situations.
        The new network for PM10 will be derived from the 
    existing network of SLAMS, NAMS, and other monitors generically 
    classified as SPMs which include industrial and special study monitors. 
    Population-oriented PM10 NAMS will generally be maintained 
    as will other key sampling locations in existing nonattainment areas, 
    and in areas whose concentrations are near the levels of the revised 
    PM10 NAAQS. Currently approved reference or equivalent 
    PM10 samplers can continue to be utilized. The revised 
    network will ensure that analysis of national trends in PM10 
    can be continued, that air surveillance in areas with established PM 
    emission control programs can be maintained, and that the 
    PM10 NAAQS will not be jeopardized by additional growth in 
    PM10 emissions. PM10 sites should be collocated 
    with new PM2.5 sites at key community-oriented monitoring 
    stations so that better definition of fine and coarse contributions to 
    PM10 can be determined to provide a better understanding of 
    exposure, emission controls, and atmospheric processes. PM10 
    sites not needed for trends or with maximum concentrations less than 60 
    percent of the NAAQS should be discontinued in a longer-term 
    PM10 network.2 The sampling frequency at all 
    PM10 sites can be changed to a minimum of once in 3 days, 
    which will be sufficient to make comparisons with the new 
    PM10 standards at most locations. Locations without high 24-
    hour concentrations of PM10 (e.g., 140 g/
    m3) may be exempted from this provision, and their sampling 
    frequency reduced to a minimum of once in 6 days.
    ---------------------------------------------------------------------------
    
        2Memorandum from William F. Hunt, Jr., Director, Emissions, 
    Monitoring, and Analysis Division dated April 22, 1997, to EPA 
    Regional Directors entitled Ambient Monitoring Reengineering (found 
    in Docket A-96-51).
    ---------------------------------------------------------------------------
    
        2. PM2.5. Consistency with the new PM2.5 
    NAAQS demands the adoption of new perspectives for identifying and 
    establishing monitoring stations for the PM2.5 ambient air 
    monitoring network. First, sites which are representative of community-
    wide air quality shall be the principal focus of the new 
    PM2.5 monitoring program; however, all eligible population-
    oriented PM2.5 sites (including regional background and 
    regional transport sites) will be used for comparisons to the new 
    NAAQS. Second, eligible SLAMS and other eligible SPMs may be averaged 
    within properly defined CMZs to better characterize exposure and air 
    quality for comparison to the annual PM2.5 NAAQS. Third, 
    population-oriented PM2.5 SLAMS and SPMs representative of 
    unique microscale or middle scale impact sites would not be eligible 
    for comparison to the annual PM2.5 NAAQS and would only be 
    compared to the 24-hour PM2.5 NAAQS. The 24-hour 
    PM2.5 NAAQS is intended to supplement the annual 
    PM2.5 standard by providing additional protection at these 
    small spatial scales. A violation of the annual PM2.5 NAAQS 
    at localized hot spot and other areas of a small spatial scale (i.e., 
    less than 0.5km in diameter) are not reflective of the data used to 
    establish the annual PM2.5 NAAQS. It is also not indicative 
    of a greater area-wide problem which would initiate the need for an 
    area-wide implementation strategy. Clearly, the combination of careful 
    network design, i.e., one that identifies the differences in monitor 
    locations, and an implementation policy that strives to develop 
    effective strategies optimizing regional and local efforts is required 
    to address the intent of the PM2.5 NAAQS.
        The new network for PM2.5 consists of a core network of 
    community-oriented SLAMS monitors (including certain SLAMS collocated 
    at PAMS), other SLAMS monitors (including background and regional 
    transport sites), a NAMS network for long-term monitoring for trends 
    purposes, and a supplementary network of SPMs. Daily sampling is 
    required at a subset of core SLAMS located in MSAs with population 
    greater than 500,000 and at core SLAMS collocated at PAMS sites. This 
    will provide more accurate and complete information on population 
    exposure. One in 3-day sampling is required at NAMS and at all other 
    SLAMS, except when exempted by the Regional Administrator, in which 
    case one in 6-day sampling is required. Frequent measurements are 
    important to characterize the day-to-day variability in 
    PM2.5 concentrations, and to understand episodic behavior of 
    PM2.5. Routine chemical speciation of PM2.5 will 
    be required for a small subset of the core SLAMS. This is necessary to 
    establish and track effective emission control strategies to assure 
    protection of the NAAQS. These sites shall be part of the future 
    PM2.5 NAMS network. Overall, many of the new 
    PM2.5 sites are expected to be located at existing 
    PM10 sites, that are representative of monitoring oriented 
    exposures and would be collocated with some PAMS sites.
        The concepts that address the intent of PM2.5 network 
    for making comparisons to the NAAQS are embodied through: (1) 
    Monitoring planning areas; (2) specially coded sites including 
    community-oriented (core) SLAMS, regional transport and regional 
    background SLAMS, and other SLAMS or SPMs whose data would be used to 
    compare to the levels of the annual and 24-hour PM2.5 NAAQS; 
    (3) SLAMS or SPMs representative of unique population-oriented 
    microscale or middle scale locations that are only eligible for 
    comparison to the 24-hour PM2.5 NAAQS, and (4) individual 
    community-oriented sites or CMZs to correspond to the spatial averaging 
    approach defined by the annual PM2.5 NAAQS.
        Core sites are community-representative monitoring sites which are 
    among the most important SLAMS for identifying areas that are in 
    violation of the PM2.5 NAAQS and to be used for the 
    associated SIP planning process. Because of their generally larger 
    spatial scales of representativeness, the core sites are the sites most 
    likely to be eligible for spatial averaging and are also vital in order 
    to establish the boundaries of potential areas of violation of the 
    NAAQS that would be reflective of the areas of highest population 
    exposure to fine particles. Core sites are neighborhood scale in their 
    spatial dimensions. Core SLAMS and specific SPM monitoring locations 
    which are eligible for spatial averaging must be identified in the PM 
    monitoring network description, satisfy criteria outlined in Appendix 
    D, and be approved by EPA. In accordance with information to be 
    specified by the AIRS guidance, the State shall assign the appropriate 
    monitoring site code when reporting these data to EPA.
        Regional transport and regional background sites are located 
    outside major metropolitan areas and would generally be upwind of one 
    or more high concentration PM2.5 impact areas. These sites 
    are expected to be in areas
    
    [[Page 38780]]
    
    of relatively low population density or in unpopulated regions. The 
    collection of data at these sites is encouraged because they are 
    critical for the complete understanding of potential pollutant 
    transport and for the development and evaluation of emission control 
    strategies. Although violations of the NAAQS may be observed at these 
    sites, the interpretation and use of such data observed at regional 
    transport and regional background locations will be addressed in the PM 
    implementation program.
        SLAMS monitoring locations generally should reflect the population-
    oriented emphasis of the new NAAQS' population risk management approach 
    and its data would be used for NAAQS comparisons. SPMs, on the other 
    hand, could represent a variety of monitoring situations, some of which 
    are not appropriate for comparison to the PM2.5 standards. 
    This includes monitoring at non-population-oriented hot spots or 
    special emissions characterization sites that do not meet EPA siting 
    criteria or required SLAMS monitoring methodology, but provide valuable 
    planning information to support the SIP process. In addition, certain 
    SLAMS and SPMs that represent small spatial scales (i.e., sites that 
    are classified as microscale or middle scale, in accordance with 
    Appendix D) would not represent average, community-oriented air 
    quality. In general, such locations would be relatively close to a 
    single PM emission source or a collection of small local sources. An 
    example of such a location is a unique microscale site in a non-
    residential part of an urban area and which may be zoned industrial. 
    Clearly, such a site should not be called a SLAMS. There might also be 
    SLAMS sites in residential districts which are representative of small 
    maximum concentration impact areas. Due to the greater spatial 
    homogeneity of fine particles, the existence of such small scale impact 
    locations is expected to be much less than that for coarse particles. 
    When SLAMS or SPMs do represent small, unique population-oriented 
    impact areas, they should be used for comparison to the 24-hour 
    PM2.5 standard but not for the annual standard. This is 
    especially true when the site is dominated by a single emission source. 
    In general, these types of small impact sites may be surrounded by 
    broader areas of more homogeneous concentrations which are reflective 
    of community-wide air quality. However, if the State chooses to monitor 
    at a unique population-oriented microscale or middle scale location and 
    the monitoring station meets all applicable 40 CFR part 58 requirements 
    (including monitoring methodology), then the data shall be used only 
    for comparison to the 24-hour PM2.5 standard. This is 
    consistent with the underlying rationale of the PM2.5 NAAQS. 
    Such monitors would require a special AIRS code when their data are 
    submitted to EPA, as specified by AIRS guidance.
        Exceptions to the use of micro and middle scale PM2.5 
    for comparison only to the 24-hour standard may exist when micro or 
    middle scale PM2.5 sites represent several small areas in 
    the monitoring domain which collectively identify a larger region of 
    localized high concentration. For example, there may be two or more 
    disjoint middle scale impact areas in a single residential district 
    that are not predominantly influenced by a single PM2.5 
    emission source. In this case, these small scale sites should be used 
    for comparison to the annual NAAQS. This is because their annual 
    average ambient air concentrations can be interpreted as if they 
    collectively represent a larger scale. In a sense, this situation can 
    be viewed as a neighborhood of small scale impact areas. These concepts 
    and associated requirements are discussed in section 2.8.1 of 40 CFR 
    part 58, Appendix D.
        The new network design and siting requirements encourage the 
    placement of PM2.5 monitors both within and outside of 
    population centers in order to: (1) Provide air quality data necessary 
    to facilitate implementation of the PM2.5 NAAQS, and (2) 
    augment the existing visibility fine particle monitoring network. The 
    coordination of these two monitoring objectives will facilitate 
    implementation of a regional haze program and lead to an integrated 
    monitoring program for fine particles.
        To achieve the appropriate level of air quality surveillance in 
    such areas, EPA believes it is important to coordinate and integrate 
    the regional background and regional transport monitoring sites 
    specified in this final rule with the existing IMPROVE monitors that 
    have been in place in a number of locations around the country since 
    the late 1980s to characterize fine particulate levels and visibility 
    in mandatory Federal Class I areas (e.g., certain national parks and 
    wilderness areas). The need for coordination and integration of 
    visibility-oriented monitoring sites will increase when EPA proposes 
    rules under section 169A of the Act to supplement the secondary NAAQS 
    in addressing regional haze. More detailed guidance on monitoring and 
    assessment requirements will be forthcoming to support this program. 
    This will include details on topics such as monitor placement, 
    monitoring methodology, duration of sampling and frequency of sampling. 
    It is anticipated, however, that the existing IMPROVE network, together 
    with sites established under this rule, would be an integral part of 
    the network for determining reasonable progress under a regional haze 
    program.
        In the meantime, EPA recommends that States, in conjunction with 
    EPA and Federal land managers, explore opportunities for expanding and 
    managing PM2.5 and visibility monitoring networks in the 
    most efficient and effective ways to meet the collective goals of these 
    programs. It is EPA's intent that monitoring conducted for purposes of 
    the PM2.5 primary and secondary NAAQS (including regional 
    background and regional transport sites), and for visibility protection 
    be undertaken as one coordinated national PM2.5 monitoring 
    program, rather than as a number of independent networks.
        Although the major emphasis of the new PM2.5 network is 
    compliance monitoring in support of the NAAQS, the network is also 
    intended to assist in reporting of data to the general public, 
    especially during air pollution episodes and to assist in the SIP 
    planning process. To these ends, additional monitoring and analyses are 
    suggested concerning the location of nephelometers (or other continuous 
    PM measuring devices) at some core monitoring sites and the collection 
    of meteorological data at core SLAMS sites (including background and 
    regional transport sites).
    
    T. Resources and Cost Estimates for New PM Networks
    
        The proposed rules contained a discussion of the costs associated 
    with the start-up and implementation of a PM2.5 network and 
    the phase-down of the existing PM10 network.
        1. Resources and costs. Several commenters expressed concern about 
    the costs of the proposed monitoring and QA/QC requirements. Most 
    commenters wanted EPA to provide the funds to meet the increased effort 
    and costs with new monies to the agencies, noting that implementing the 
    network in a timely manner will depend heavily on timely grant 
    assistance from EPA.
        Numerous commenters expressed concern that either not enough 
    monitoring money was projected or that the program would be an unfunded 
    mandate. Commenters felt that EPA should budget the funds necessary to 
    develop an adequate PM2.5 network that will support all SIP 
    obligations, including support for speciation. Funds to implement a new 
    monitoring network should include one-time funding to
    
    [[Page 38781]]
    
    procure sampling, calibration, laboratory, and audit equipment, plus 
    annual funding to support field and laboratory operations.
        Several commenters felt that EPA estimates were too low, citing 
    underestimates for additional operational, analytical, and equipment 
    costs including daily sampling; speciation; startup for new monitoring 
    locations; laboratory modifications; operator training; travel; data 
    collection and reporting; greater QA equipment and manpower needs; 
    field testing of reference and equivalent methods; and continuous 
    monitors. No commenter felt that EPA estimates were too high.
        A few commenters addressed the suggested portions of the total 
    monitoring program cost for speciation. Several commenters suggested 
    that the cost of requiring speciation could be reduced by limiting the 
    requirement to a subset of the daily monitoring sites, or offset by 
    eliminating the requirement for daily sampling, noting that any cost 
    savings would be overwhelmed by the greater number of PM2.5 
    sites and the number of sites conducting everyday sampling.
        EPA understands the complexities and resource demands required by 
    State and local agencies in establishing and implementing the new 
    regulations. In its review of the comments on the use of the proposed 
    Federal reference sampler and associated quality assurance 
    requirements, the Agency has published more cost-effective requirements 
    with this final rule for monitoring network design, methodology, and 
    quality assurance. Likewise, EPA recognizes the subsequent need for it 
    to provide technical and financial assistance. In this regard, some 
    control agencies have used FY-97 grant allocations to procure 
    PM2.5 prototype instruments or upgrade their filter weighing 
    facilities. Additionally, the Agency has designated approximately 
    $10,935,000 in section 105 grant monies for distribution to States in 
    FY-98. EPA intends to assign a high priority to the PM2.5 
    monitoring program through its section 105 grants, and additional grant 
    dollars have been earmarked by EPA for subsequent years which should 
    ensure successful implementation of the PM2.5 monitoring 
    program.
        2. Revised cost analysis. In response to comments on cost 
    estimation and new requirements described earlier, EPA has revised its 
    estimates for the projected PM10 and PM2.5 
    networks. EPA believes that it has both improved its cost estimates and 
    more adequately addressed the needs for the PM monitoring program. The 
    net costs associated with the final PM rules promulgated today include 
    the start-up and implementation costs associated with the new 
    PM2.5 network and the cost savings associated with phase-
    down of the existing PM10 network. The estimated costs in 
    the preamble have been revised to reflect changes to the regulations 
    based on comments received on the proposed changes in 40 CFR parts 50, 
    53, and 58. In particular, PM2.5 network costs have been 
    revised to reflect an increase in the number of sites to 1,500, newer 
    cost estimates for prototype samplers, equipping many sites with 
    sequential samplers to provide for greater operational flexibility, 
    reducing the number and frequency of audits with federal reference 
    method samplers, and providing for additional multi-filter sampling to 
    determine PM2.5 constituent species. In addition, 
    PM10 network costs have been revised to reflect an increase 
    in the remaining number of PM10 sites to 900 and a sampling 
    frequency of once every 3 days (instead of once every 6 days, as 
    proposed) for those sites that previously had been sampling everyday, 
    every 2 days, or every 6 days.
        Table 2 shows the PM2.5 network phase-in data including 
    number of sites and samplers, costs for capital equipment, sampling and 
    quality assurance, filter analyses, and special studies. Table 3 
    provides a breakdown of the costs associated with the filter analyses. 
    Table 4 provides a breakdown of the phase-down costs for the 
    PM10 network. The costs are shown for a current network of 
    approximately 1,650 sites in 1997 and the phase-down to a future 
    projected network of 900 sites. Table 5 shows the cost of PM monitoring 
    according to sampling frequency and the type of PM monitor. Details of 
    this information can be found in the Information Collection Request for 
    these requirements. Tables 2 through 5 follow.
    
                                              Table 2.--PM2.5 Network Costs                                         
                                              [Thousands of Actual Dollars]                                         
    ----------------------------------------------------------------------------------------------------------------
                                     Number of   Number of    Capital    Sampling     Filter     Special     Total  
                  Year                 Sites      Samplers      Cost       & QA      Analysis    Studies      Cost  
    ------------------------------------------------\1\--------------------------------\2\--------------------------
    1997...........................          0           0      $4,500  .........  ...........  .........     $4,500
    1998...........................        724         861      $8,963    $10,216        $472      $1,426    $18,225
    1999...........................      1,200       1,512     $14,877    $17,938      $2,325      $3,004    $38,143
    2000...........................      1,500       1,887      $7,155    $26,697      $3,649   .........   $37,502 
    ----------------------------------------------------------------------------------------------------------------
    \1\ The PM2.5 network includes a mature network of 332 collocated samplers for QA purposes.                     
    \2\ Three different types of filter analyses are anticipated (exceedance analyses, screening analyses, and      
      detailed analyses).                                                                                           
    
    
    
                    Table 3.--Cost for PM2.5 Filter Analyses                
    ------------------------------------------------------------------------
              Type of Filter Analysis             Estimated Cost per Sample 
    ------------------------------------------------------------------------
    Exceedance Analysis                                                 $200
        High PM2.5 concentration events are                                 
         analyzed for particle size and                                     
         composition utilizing optical or                                   
         electron microscopy..................  ............................
    Screening Analysis                                                  $150
        Multi-filter analyses including (1) x-                              
         ray fluorescence (XRF) for elemental                               
         composition (crustal material,                                     
         sulfur, and heavy metals); (2) ion                                 
         chromatography for ions such as                                    
         sulfate, nitrate, and chloride; (3)                                
         thermal-optical analysis for                                       
         elemental/organic/total carbon.......  ............................
    Detailed Analysis                                                   $400
        Analysis for speciated organic                                      
         composition..........................  ............................
    ------------------------------------------------------------------------
    
    
    
    [[Page 38782]]
    
    
                                              Table 4.--PM10 Network Costs                                          
                                              [Thousands of Actual Dollars]                                         
    ----------------------------------------------------------------------------------------------------------------
                                                                       Capital Cost     Operation &                 
                  Year                   Number of       Number of       to Remove      Maintenance     Total Cost  
                                           Sites        Samplers\1\        Sites           Cost                     
    ----------------------------------------------------------------------------------------------------------------
    1997............................           1,650           1,810  ..............         $15,861         $15,861
    1998............................           1,450           1,610            $137         $13,358         $13,495
    1999............................           1,250           1,410             $89         $11,946         $12,035
    2000............................             900           1,060            $159          $9,134          $9,293
    ----------------------------------------------------------------------------------------------------------------
    \1\ The PM10 network includes 160 collocated samplers for QA purposes.                                          
    
    
    
                                       Table 5.--Costs for Particulate Monitoring                                   
                                                    [In 1997 Dollars]                                               
    ----------------------------------------------------------------------------------------------------------------
                                                                                    Annual Operation & Maintenance  
        PM Monitor and Sampling Frequency            One-Time Capital Cost                       Cost               
    ----------------------------------------------------------------------------------------------------------------
    PM10 1-in-6 day sampling schedule.......  $7,700 to $14,800.................  $8,000 to $8,900                  
    PM10 1-in-3 day sampling schedule.......  $7,700 to $19,400.................  $12,400                           
    PM2.5 1-in-6 day sampling schedule......  $9,300 to $20,700.................  $11,300 to $12,500                
    PM2.5 1-in-3 day sampling schedule......  $12,800 to $20,700................  $17,000 to $18,600                
    PM2.5 every day sampling................  $12,900 to $20,700................  $20,700 to $22,200                
    Nephelometer (continuous)...............  $21,000...........................  $19,700                           
    ----------------------------------------------------------------------------------------------------------------
    
    V. References
    
        (1) Information Collection Request, 40 CFR Part 58, Ambient Air 
    Quality Surveillance, OMB #2060-0084, EPA ICR No. 0940.14, U.S. 
    Environmental Protection Agency, Office of Air Quality Planning and 
    Standards, Research Triangle Park, NC 27711.
    
    VI. Regulatory Assessment Requirements
    
    A. Regulatory Impact Analysis
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
    Agency must determine whether the regulatory action is ``significant'' 
    and therefore subject to Office of Management and Budget (OMB) review 
    and to the requirements of the Executive Order. The Order defines 
    ``significant regulatory action'' as one that is likely to result in a 
    rule that may:
        (1) Have an annual effect on the economy of $100 million or more or 
    adversely affect in a material way the economy, a sector of the 
    economy, productivity, competition, jobs, the environment, public 
    health or safety, or State, local, or governments or communities;
        (2) Create a serious inconsistency or otherwise interfere with an 
    action taken or planned by another Agency;
        (3) Materially alter the budgetary impact of entitlements, grants, 
    user fees, or loan programs or the rights and obligations or recipients 
    thereof; or
        (4) Raise novel legal or policy issues arising out of legal 
    mandates, the President's priorities, or the principles set forth in 
    the Executive Order.
        It has been determined that this rule is not a ``significant 
    regulatory action'' under the terms of the Executive Order 12866 and is 
    therefore not subject to formal OMB review. However, this rule is being 
    reviewed by OMB under Reporting and Recordkeeping Requirements.
    
    B. Paperwork Reduction Act
    
        The information collection requirements contained in this rule have 
    been submitted for approval to OMB under the Paperwork Reduction Act, 
    44 U.S.C. 3501 et seq. An Information Collection Request document has 
    been prepared by EPA (ICR No. 0940.14) and a copy may be obtained from 
    Sandy Farmer, Information Policy Branch, EPA, 401 M St., SW., Mail Code 
    2137, Washington, DC 20460; or by calling (202) 260-2740.
        1. Need and use of the collection. The main use for the collection 
    of the data is to implement the air quality standards. The various 
    parameters reported as part of this ICR are necessary to ensure that 
    the information and data collected by State and local agencies to 
    assess the nation's air quality are defensible, of known quality, and 
    meet EPA's data quality goals of completeness, precision, and accuracy.
        The need and authority for this information collection is contained 
    in section 110(a)(2)(C) of the Act, that requires ambient air quality 
    monitoring for purposes of the SIP and reporting of the data to EPA, 
    and section 319, that requires the reporting of a daily air pollution 
    index. The legal authority for this requirement is the Ambient Air 
    Quality Surveillance Regulations, 40 CFR 58.20, 58.21, 58.25, 58.26, 
    58.28, 58.30, 58.31, 58.35, and 58.36.
        EPA's Office of Air Quality Planning and Standards uses ambient air 
    monitoring data for a wide variety of purposes, including making NAAQS 
    attainment/nonattainment decisions; determining the effectiveness of 
    air pollution control programs; evaluating the effects of air pollution 
    levels on public health; tracking the progress of SIPs; providing 
    dispersion modeling support; developing responsible, cost-effective 
    control strategies; reconciling emission inventories; and developing 
    air quality trends. The collection of PM2.5 data is 
    necessary to support the PM2.5 NAAQS, and the information 
    collected will have practical utility as a data analysis tool.
        The State and local agencies with responsibility for reporting 
    ambient air quality data and information as requested by these 
    regulations will submit these data electronically to the U.S. EPA's 
    Aerometric Information Retrieval System, Air Quality Subsystem (AIRS-
    AQS). Quality assurance/quality control records and monitoring network 
    documentation are also maintained by each State/local agency, in AIRS-
    AQS electronic format where possible.
        2. Reporting and recordkeeping burden. The total annual collection 
    and reporting burden associated with this rule is estimated to be 
    785,430 hours. Of
    
    [[Page 38783]]
    
    this total, 778,826 hours are estimated to be for data reporting, or an 
    average of 5,991 hours for the estimated 130 respondents. The remainder 
    of 6,604 hours for recordkeeping burden averages 51 hours for the 
    estimated 130 respondents. The capital operation/maintenance costs 
    associated with this rule are estimated to be $32,463,626. These 
    estimates include time for reviewing instructions, searching existing 
    data sources, gathering and maintaining the data needed, and completing 
    and reviewing the collection of information.
        The frequency of data reporting for the NAMS and the SLAMS air 
    quality data as well as the associated precision and accuracy data are 
    submitted to EPA according to the schedule defined in 40 CFR part 58. 
    This regulation currently requires that State and local air quality 
    management agencies report their data within 90 days after the end of 
    the quarter during which the data were collected. The annual SLAMS 
    report is submitted by July 1 of each year for data collected from 
    January 1 through December 31 of the previous year in accordance with 
    40 CFR part 58.26. This certification also implies that all SPM data to 
    be used for regulatory purposes by the affected State or local air 
    quality management agency have been submitted by July 1.
        3. Burden. Burden means the total time, effort, or financial 
    resources expended by persons to generate, maintain, retain, or 
    disclose or provide information to or for a Federal agency. This 
    includes the time needed to review instructions; develop, acquire, 
    install, and utilize technology and systems for the purpose of 
    collecting, validating, and verifying information, processing and 
    maintaining information, and disclosing and providing information; 
    adjust the existing ways to comply with any previously applicable 
    instructions and requirements; train personnel to be able to respond to 
    a collection of information; search data sources; complete and review 
    the collection of information; and transmit or otherwise disclose the 
    information.
        An Agency may not conduct or sponsor, and a person is not required 
    to respond to a collection of information unless it displays a 
    currently valid OMB control number. The OMB control numbers for EPA's 
    regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.
    
    C. Impact on Small Entities
    
        Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 
    U.S.C. 605(b), the EPA Administrator certifies that this rule will not 
    have a significant economic impact on a substantial number of small 
    entities. This rulemaking package does not impose any additional 
    requirements on small entities because it applies to governments whose 
    jurisdictions cover more than 200,000 population. Under the Regulatory 
    Flexibility Act, governments are small entities only if they have 
    jurisdictions of less than 50,000 people. In addition, this rule 
    imposes no enforceable duties on small businesses.
    
    D. Unfunded Mandates Reform Act of 1995
    
        Under sections 202, 203, and 205 of the Unfunded Mandates Reform 
    Act of 1995 signed into law on March 22, 1995, EPA must undertake 
    various actions in association with proposed or final rules that 
    include a Federal mandate that may result in estimated costs of $100 
    million or more to the private sector, or to State or local governments 
    in the aggregate.
        EPA has determined that this rule does not contain a Federal 
    mandate that may result in an administrative burden of $100 million or 
    more for State and local governments, in the aggregate, or the private 
    sector in any one year. The Agency's economic analysis indicates that 
    the total incremental administrative cost will be approximately 
    $56,611,000 in 1997 dollars for the 3 years to phase in the network, or 
    an average of $18,820,000 per year for the 3-year implementation 
    period. Table 6 shows how this 3-year average was derived for the 
    various cost elements of monitoring. While this table represents the 3-
    year period 1998-2000, the total cost for PM2.5 monitoring 
    include the initial capital costs anticipated in 1997. In addition, 
    this rule imposes no enforceable duties on small businesses.
    
                                                            Table 6.--Cost Elements for PM Monitoring                                                       
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Administrative Cost Based on 3-year Average (thousands of constant 1997 dollars)*                                   
    ---------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Current                                        Revised                                                     
                Cost/Element            ----------------------------------------------------------------------------------------------       Net Change     
                                                  PM10                    PM10                   PM2.5                  Totals                              
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Network design                                               $0                      $1,174                 $1,174                 $1,174               
    Site installation                                            $0                      $1,532                 $1,532                 $1,532               
    Sampling & analysis                  $3,518                  $2,528                  $7,915                 $10,443                $6,926               
    Maintenance                          $1,658                  $1,192                  $2,285                 $3,477                 $1,818               
    Data management                      $2,098                  $1,508                  $3,370                 $4,878                 $2,780               
    Quality assurance                    $2,940                  $2,113                  $3,342                 $5,455                 $2,515               
    Supervision                          $3,350                  $2,408                  $3,068                 $5,476                 $2,125               
    Summary                              $13,564                 $9,749                  $22,684                $32,433                $18,820              
    *Totals are rounded                                                                                                                                     
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38784]]
    
    List of Subjects in 40 CFR Parts 53 and 58
    
        Environmental protection, Administrative practice and procedure, 
    Air pollution control, Intergovernmental relations, Reporting and 
    recordkeeping requirements.
    
        Dated: July 16, 1997.
    
    Carol M. Browner,
    Administrator.
        For the reasons set forth in the preamble, title 40, chapter I, 
    parts 53 and 58 of the Code of Federal Regulations are amended as 
    follows:
    
    PART 53--[AMENDED]
    
        1. In part 53:
        a. The authority citation for part 53 continues to read as follows:
    
        Authority: Sec. 301(a) of the Clean Air Act (42 U.S.C. Sec. 
    1857g(a)) as amended by sec. 15(c)(2) of Pub. L. 91-604, 84 Stat. 
    1713, unless otherwise noted.
    
        b. Subpart A is revised to read as follows:
    Subpart A--General Provisions
    Sec.
    53.1   Definitions.
    53.2   General requirements for a reference method determination.
    53.3   General requirements for an equivalent method determination.
    53.4   Applications for reference or equivalent method 
    determinations.
    53.5   Processing of applications.
    53.6   Right to witness conduct of tests.
    53.7   Testing of methods at the initiative of the Administrator.
    53.8   Designation of reference and equivalent methods.
    53.9   Conditions of designation.
    53.10   Appeal from rejection of application.
    53.11   Cancellation of reference or equivalent method designation.
    53.12   Request for hearing on cancellation.
    53.13   Hearings.
    53.14   Modification of a reference or equivalent method.
    53.15   Trade secrets and confidential or privileged information.
    53.16   Supersession of reference methods.
    Tables to Subpart A of Part 53
    Table A-1.--Summary of Applicable Requirements for Reference 
    Equivalent Methods for Air Monitoring of Criteria Pollutants
    Appendix A to Subpart A of Part 53--References
    
    Subpart A--General Provisions
    
    
    Sec. 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.
        Administrator means the Administrator of the Environmental 
    Protection Agency or the Administrator's authorized representative.
        Agency means the Environmental Protection Agency.
        Applicant means a person or entity who submits an application for a 
    reference or equivalent method determination under Sec. 53.4, or a 
    person or entity who assumes the rights and obligations of an applicant 
    under Sec.  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 
    reference method determination or an equivalent method determination is 
    submitted in accordance with Sec. 53.4, or a method tested at the 
    initiative of the Administrator in accordance with Sec. 53.7.
        Class I equivalent method means an equivalent method for 
    PM2.5 which is based on a sampler that is very similar to 
    the sampler specified for reference methods in Appendix L of this part, 
    with only minor deviations or modifications, as determined by EPA.
        Class II equivalent method means an equivalent method for 
    PM2.5 that utilizes a PM2.5 sampler in which an 
    integrated PM2.5 sample is obtained from the atmosphere by 
    filtration and is 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 of part 50 of this chapter, as determined by EPA.
         Class III equivalent method means an equivalent method for 
    PM2.5 that has been determined by EPA not to be a Class I or 
    Class II equivalent method. This fourth type of PM2.5 method 
    includes alternative equivalent method samplers and continuous 
    analyzers, based on designs and measurement principles different from 
    those specified for reference methods (e.g., a means for estimating 
    aerosol mass concentration other than by conventional integrated 
    filtration followed by equilibration and gravimetric analysis. These 
    samplers (or monitors) are those deemed to be substantially different 
    from reference method samplers and are likely to use components and 
    methods other than those specified for reference method samplers.
        Collocated describes two or more air samplers, analyzers, or other 
    instruments which sampler the ambient air that are operated 
    silmultaneously 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.
        Equivalent method 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 Sec. 53.11 or Sec. 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.
        (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 
    reference and 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 therof, is performed manually. A 
    method for PM10 or PM2.5 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
    
    [[Page 38785]]
    
     automatically collecting a series of sequential samples.
        PM2.5 sampler means a device, associated with a manual 
    method for measuring PM2.5, designed to collect 
    PM2.5 from an ambient air sample, but lacking the ability to 
    automatically analyze or measure the collected sample to determine the 
    mass concentrations of PM2.5 in the sampled air.
        PM10 sampler means a device, associated with a manual 
    method for measuring PM10, designed to collect 
    PM10 from an ambient air sample, but lacking the ability to 
    automatically analyze or measure the collected sample to determine the 
    mass concentrations of PM10 in the sampled air.
        Reference method 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 Sec. 53.11 or Sec. 53.16.
        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.
        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 PM10 sampler or a 
    PM2.5 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 
    reference method or an equivalent method for purposes other than 
    resale.
    
    
    Sec. 53.2   General requirements for a reference method determination.
    
        The following general requirements for a reference method 
    determination are summarized in Table A-1 of this subpart.
        (a) Manual methods. (1) For measuring sulfur dioxide 
    (SO2) and lead, Appendices A and G of part 50 of this 
    chapter specify unique manual reference methods for those pollutants. 
    Except as provided in Sec. 53.16, other manual methods for 
    SO2 and lead will not be considered for reference method 
    determinations under this part.
        (2) A reference method for measuring PM10 must be a 
    manual method that meets all requirements specified in Appendix J of 
    part 50 of this chapter and must include a PM10 sampler that 
    has been shown in accordance with this part to meet all requirements 
    specified in subparts A and D of this part.
        (3) A reference method for measuring PM2.5 must be a 
    manual method that meets all requirements specified in Appendix L of 
    part 50 of this chapter and must include a PM2.5 sampler 
    that has been shown in accordance with this part to meet the applicable 
    requirements specified in subparts A and E of this part. Further, 
    reference method samplers must be manufactured in an ISO 9001-
    registered facility, as defined in Sec. 53.1 and as set forth in 
    Sec. 53.51, and the Product Manufacturing Checklist set forth in 
    subpart E of this part must be completed by an ISO-certified auditor, 
    as defined in Sec. 53.1, and submitted to EPA annually to retain a 
    PM2.5 reference method designation.
        (b) Automated methods. An automated reference method for measuring 
    carbon monoxide (CO), ozone (O3), and nitrogen dioxide 
    (NO2) must utilize the measurement principle and calibration 
    procedure specified in the appropriate appendix to part 50 of this 
    chapter and must have been shown in accordance with this part to meet 
    the requirements specified in subpart B of this part.
    
    
    Sec. 53.3   General requirements for an equivalent method 
    determination.
    
        (a) Manual methods. A manual equivalent method must have been shown 
    in accordance with this part to satisfy the applicable requirements 
    specified in subpart C of this part. In addition, PM10 or 
    PM2.5 samplers associated with manual equivalent methods for 
    PM10 or PM2.5 must have been shown in accordance 
    with this part to satisfy the following additional requirements:
        (1) A PM10 sampler associated with a manual method for 
    PM10 must satisfy the requirements of subpart D of this 
    part.
        (2) A PM2.5 Class I equivalent method sampler must 
    satisfy all requirements of subparts C and E of this part, which 
    include appropriate demonstration that each and every deviation or 
    modification from the reference method sampler specifications does not 
    significantly alter the performance of the sampler.
        (3) A PM2.5 Class II equivalent method sampler must 
    satisfy the applicable requirements of subparts C, E, and F of this 
    part.
        (4) Requirements for PM2.5 Class III equivalent method 
    samplers are not provided in this part because of the wide range of 
    non-filter-based measurement technologies that could be applied and the 
    likelihood that these requirements will have to be specifically adapted 
    for each such type of technology. Specific requirements will be 
    developed as needed and may include selected requirements from subparts 
    C, E, or F of this part or other requirements not contained in this 
    part.
        (5) All designated equivalent methods for PM2.5 must be 
    manufactured in an ISO 9001-registered facility, as defined in 
    Sec. 53.1 and as set forth in Sec. 53.51, and the Product Manufacturing 
    Checklist set forth in subpart E of this part must be completed by an 
    ISO-certified auditor, as defined in Sec. 53.1, and submitted to EPA 
    annually to retain a PM2.5 equivalent method designation.
        (b) Automated methods. (1) Automated equivalent methods for 
    pollutants other than PM2.5 or PM10 must have 
    been shown in accordance with this part to satisfy the requirements 
    specified in subparts B and C of this part.
        (2) Automated equivalent methods for PM10 must have been 
    shown in accordance with this part to satisfy the requirements of 
    subparts C and D of this part.
        (3) Requirements for PM2.5 Class III automated 
    equivalent methods for PM2.5 are not provided in this part 
    because of the wide range of non-filter-based measurement technologies 
    that could be applied and the likelihood that these requirements will 
    have to be specifically adapted for each such type of technology. 
    Specific requirements will be developed as needed and may include 
    selected requirements from subparts C, E, or F of this part or other 
    requirements not contained in this part.
        (4) All designated equivalent methods for PM2.5 must be 
    manufactured in an ISO 9001-registered facility, as set forth in 
    subpart E of this part, and the Product Manufacturing Checklist set 
    forth in subpart E of this part must be completed by an ISO-certified 
    auditor and submitted to EPA annually to retain a PM2.5 
    equivalent method designation.
        (5) All designated equivalent methods for PM2.5 must 
    also meet annual requirements for network operating performance 
    determined as set forth in section 6 of Appendix A of part 58 of this 
    chapter.
    
    
    Sec. 53.4   Applications for reference or equivalent method 
    determinations.
    
        (a) Applications for reference or equivalent method determinations 
    shall be submitted in duplicate to: Director, National Exposure 
    Research Laboratory, Department E (MD-77B), U.S. Environmental 
    Protection Agency, Research Triangle Park, North Carolina 27711.
    
    [[Page 38786]]
    
        (b) Each application shall be signed by an authorized 
    representative of the applicant, shall be marked in accordance with 
    Sec. 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 PM2.5 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 Sec. 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 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 Appendix L 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 
    Sec. 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 (b)(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 
    paragraphs 4 through 6 of Reference 2 of Appendix A of this subpart, 
    Part b, sections 3.3.1 (paragraph 1) and 3.5.1 (paragraphs 2 and 3) and 
    in paragraphs 1 through 3 of Reference 5 (section 4.8, Records) 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.
        (c) For candidate automated methods and candidate manual methods 
    for PM10 and PM2.5, 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 PM2.5 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 Sec. 53.9(c)). For methods for 
    PM2.5, the warranty program must
    
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    ensure that the required specifications (see Table A-1 of 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 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 Appendix A of this subpart requires documented 
    procedures for control of nonconforming product, including review and 
    acceptable alternatives for disposition; section 4.14 in 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 for 
    PM2.5, the applicant shall provide to EPA for test purposes 
    one sampler or analyzer that is representative of the sampler or 
    analyzer associated with the candidate method. The sampler or analyzer 
    shall be shipped FOB destination to Department E, (MD-77B), U.S. EPA, 
    79 T.W. Alexander Drive, Research Triangle Park, NC 27711, scheduled to 
    arrive concurrent with or within 30 days of the arrival of the other 
    application materials. This analyzer or sampler may be subjected to 
    various tests that EPA determines to be necessary or appropriate under 
    Sec. 53.5(f), and such tests may include special tests not described in 
    this part. If the instrument submitted under this paragraph 
    malfunctions, becomes inoperative, or fails to perform as represented 
    in the application before the necessary EPA testing is completed, the 
    applicant shall be afforded an opportunity to repair or replace the 
    device at no cost to EPA. Upon completion of EPA testing, the analyzer 
    or sampler submitted under this paragraph 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. EPA does not 
    warrant or assume any liability for the condition of the analyzer or 
    sampler upon return to the applicant.
    
    
    Sec. 53.5   Processing of applications.
    
        After receiving an application for a reference or equivalent method 
    determination, the Administrator will publish notice of the application 
    in the Federal Register and, 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 Sec. 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).
    
    
    Sec. 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.
    
    
    Sec. 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 Sec. 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 Sec. 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 
    Sec. 53.8 or is specified or designated as a reference method in 
    accordance with Sec. 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.
    
    
    Sec. 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 a 
    reference method or equivalent method (as applicable), and a notice of 
    the
    
    [[Page 38788]]
    
    designation shall be submitted for publication in the Federal Register 
    not later than 15 days after the determination is made.
        (b) A notice indicating that the method has been determined to be a 
    reference method or an equivalent method shall be sent to the 
    applicant. This notice shall constitute proof of the determination 
    until a notice of designation is published in accordance with paragraph 
    (a) of this section.
        (c) The Administrator will maintain a current list of methods 
    designated as reference or equivalent methods 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 for inspection or copying 
    at EPA Regional Offices.
    
    
    Sec. 53.9   Conditions of designation.
    
        Designation of a candidate method as a reference method or 
    equivalent method 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 Sec. 53.11.
        (a) Any method offered for sale as a reference or equivalent method 
    shall be accompanied by a copy of the manual referred to in 
    Sec. 53.4(b)(3) when delivered to any ultimate purchaser.
        (b) Any method offered for sale as a reference or equivalent method 
    shall generate no unreasonable hazard to operators or to the 
    environment during normal use or when malfunctioning.
        (c) Any analyzer, PM10 sampler, or PM2.5 
    sampler offered for sale as part of a reference or equivalent method 
    shall function within the limits of the performance specifications 
    referred to in Sec. 53.20(a), Sec. 53.30(a), Sec. 53.50, or Sec. 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 
    Sec. 53.4(b)(3).
        (d) Any analyzer, PM10 sampler, or PM2.5 
    sampler offered for sale as a reference or equivalent method shall bear 
    a prominent, permanently affixed label or sticker indicating that the 
    analyzer or sampler has been designated by EPA as a reference method or 
    as an equivalent method (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 reference or equivalent 
    method 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 reference or equivalent 
    method.
        (f) An applicant who offers analyzers, PM10 samplers, or 
    PM2.5 samplers for sale as reference or equivalent methods 
    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 reference or equivalent 
    method designation applicable to such an analyzer or sampler, the 
    applicant shall notify all ultimate purchasers of the analyzer or 
    PM2.5 or PM10 sampler within 30 days if the 
    designation has been canceled in accordance with Sec. 53.11 or 
    Sec. 53.16 or if adjustment of the analyzer or sampler is necessary 
    under Sec. 53.11(b).
        (g) If an applicant modifies an analyzer, PM10 sampler, 
    or PM2.5 sampler that has been designated as a reference or 
    equivalent method, 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 
    Sec. 53.14(c) that the existing designation or a new designation will 
    apply to the modified analyzer, PM10 sampler, or 
    PM2.5 sampler or has applied for and received notice under 
    Sec. 53.8(b) of a new reference or equivalent method determination for 
    the modified analyzer or sampler.
        (h) An applicant who has offered PM2.5 samplers or 
    analyzers for sale as part of a reference or equivalent method 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 reference or 
    equivalent method designation under Sec. 53.11.
        (i) An applicant who has offered PM2.5 samplers or 
    analyzers for sale as part of a reference or equivalent method may 
    continue to do so only so long as updates of the Product Manufacturing 
    Checklist set forth in subpart E of this part are submitted annually. 
    In the event that an annual Checklist update is not received by EPA 
    within 12 months of the date of the last such submitted Checklist or 
    Checklist update, EPA shall notify the applicant within 30 days that 
    the Checklist update has not been received and shall, within 30 days 
    from the issuance of such notification, issue a preliminary finding and 
    notification of possible cancellation of the reference or equivalent 
    method designation under Sec. 53.11.
    
    
    Sec. 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.
    
    
    Sec. 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 Sec. 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
    
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    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 Sec. 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 
    Sec. 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 
    Sec. 53.8(c). If a hearing has been requested and granted in accordance 
    with Sec. 53.12, action under this paragraph (d) will be taken only 
    after completion of proceedings (including any administrative review) 
    conducted in accordance with Sec. 53.13 and only if the decision of the 
    Administrator reached in such proceedings is that the designation in 
    question should be canceled.
    
    
    Sec. 53.12   Request for hearing on cancellation.
    
        Within 60 days after publication of a notice in accordance with 
    Sec. 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 
    Sec. 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.
    
    
    Sec. 53.13   Hearings.
    
        (a)(1) After granting a request for a hearing under Sec. 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 Sec. 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 Sec. 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.
    
    
    Sec. 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
    
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    method, including but not limited to modifications of design or 
    construction or of operational and maintenance procedures specified in 
    the operation manual (see Sec. 53.9(g)). The report shall be signed by 
    an authorized representative of the applicant, marked in accordance 
    with Sec. 53.15 (if applicable), and addressed as specified in 
    Sec. 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 30 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 Sec. 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 30-day period 
    shall commence upon receipt of the additional information).
        (5) Send notice to the applicant that additional tests are 
    necessary and specify what tests are necessary and how they shall be 
    interpreted (in such cases, the 30-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 30-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.
    
    
    Sec. 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).
    
    
    Sec. 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 Sec. 53.4 and shall 
    indicate therein that such consideration is desired. The application 
    shall include, in addition to the information required by Sec. 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.
    
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        (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 Sec. 53.8(c). The requirements and procedures for cancellation 
    set forth in Sec. 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 Sec. 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.
    
    Tables to Subpart A of Part 53
    
                  Table A-1.--Summary of Applicable Requirements for Reference and Equivalent Methods for Air Monitoring of Criteria Pollutants             
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Applicable Subparts of part 53        
                  Pollutant                 Ref. or Equivalent      Manual or Automated   Applicable part 50 -----------------------------------------------
                                                                                               Appendix          A       B       C       D       E       F  
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    SO2.................................  Reference.............  Manual................  A                   ......  ......  ......  ......  ......  ......
                                                                  Manual................  ..................                 >                         
                                          Equivalent............  Automated.............  ..................         >       >                         
    CO..................................  Reference.............  Automated.............  C                          >                                 
                                                                  Manual................  ..................                 >                         
                                          Equivalent............  Automated.............  ..................         >       >                         
    O3..................................  Reference.............  Automated.............  D                          >                                 
                                                                  Manual................  ..................                 >                         
                                          Equivalent............  Automated.............  ..................         >       >                         
    NO2.................................  Reference.............  Automated.............  F                          >                                 
                                                                  Manual................  ..................                 >                         
                                          Equivalent............  Automated.............  ..................         >       >                         
    Pb..................................  Reference.............  Manual................  G                   ......  ......  ......  ......  ......  ......
                                          Equivalent............  Manual................  ..................                 >                         
    PM10................................  Reference.............  Manual................  J                                          >                 
                                                                  Manual................  ..................                 >       >                 
                                          Equivalent............  Automated.............  ..................                 >       >                 
    PM2.5...............................  Reference.............  Manual................  L                                                  >         
                                          Equivalent Class I....  Manual................  L                                  >               >         
                                          Equivalent Class II...  Manual................  L                                  >               >       > 
                                          Equivalent Class III..  Manual or Automated...  ..................             > \1\           > \1\   > \1\ 
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    \1\ Note: Because of the wide variety of potential devices possible, the specific requirements applicable to a Class III candidate equivalent method for
      PM2.5 are not specified explicitly in this part but, instead, shall be determined on a case-by-case basis for each such candidiate method.            
    
    
    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 Control, 611 East Wisconsin Avenue, Milwaukee, WI 53202.
        (2) American National Standard--Specifications and Guidelines 
    for Quality Systems for Environmental Data Collection and 
    Environmental Technology Programs, ANSI/ASQC E41994. Available from 
    American Society for Quality Control, 611 East Wisconsin Avenue, 
    Milwaukee, WI 53202.
        (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) Copies of section 2.12 of the Quality Assurance Handbook for 
    Air Pollution
    
    [[Page 38792]]
    
    Measurement Systems, Volume II, Ambient Air Specific Methods, EPA/
    600/R-94/038b, are available from Department E (MD-77B), U.S. EPA, 
    Research Triangle Park, NC 27711.
        c. Subpart C is revised to read as follows:
    Subpart C--Procedures for Determining Comparability Between Candidate 
    Methods and Reference Methods
    Sec.
    53.30   General provisions.
    53.31   Test conditions.
    53.32   Test procedures for methods for SO2, CO, 
    O3, and NO2.
    53.33   Test procedure for methods for lead.
    53.34   Test procedure for methods for PM10 and 
    PM2.5.
    Tables to Subpart C of Part 53
    Table C-1.--Test Concentration Ranges, Number of Measurements 
    Required, and Maximum Discrepancy Specification
    Table C-2.--Sequence of Test Measurements
    Table C-3.--Test Specifications for Lead Methods
    Table C-4.--Test Specifications for PM10 and 
    PM2.5 Methods
    Figures to Subpart C of Part 53
    Figure C-1.--Suggested Format for Reporting Test Results
    Appendix A to Subpart C of Part 53--References
    
    Subpart C--Procedures for Determining Comparability Between 
    Candidate Methods and Reference Methods
    
    
    Sec. 53.30   General provisions.
    
        (a) Determination of comparability. The test procedures prescribed 
    in this subpart shall be used to determine if a candidate method is 
    comparable to a reference method when both methods measure pollutant 
    concentrations in ambient air.
        (1) Comparability is shown for SO2, CO, O3, 
    and NO2 methods when the differences between:
        (i) Measurements made by a candidate manual method or by a test 
    analyzer representative of a candidate automated method.
        (ii) Measurements made simultaneously by a reference method, are 
    less than or equal to the values specified in the last column of Table 
    C-1 of this subpart.
        (2) Comparability is shown for lead methods when the differences 
    between:
        (i) Measurements made by a candidate method.
        (ii) Measurements made by the reference method on simultaneously 
    collected lead samples (or the same sample, if applicable), are less 
    than or equal to the value specified in Table C-3 of this subpart.
        (3) Comparability is shown for PM10 and PM2.5 
    methods when the relationship between:
        (i) Measurements made by a candidate method.
        (ii) Measurements made by a reference method on simultaneously 
    collected samples (or the same sample, if applicable) at each of two 
    test sites, is such that the linear regression parameters (slope, 
    intercept, and correlation coefficient) describing the relationship 
    meet the values specified in Table C-4 of this subpart.
        (b) Selection of test sites--(1) All methods. Each test site shall 
    be in a predominately urban area which can be shown to have at least 
    moderate concentrations of various pollutants. The site shall be 
    clearly identified and shall be justified as an appropriate test site 
    with suitable supporting evidence such as maps, population density 
    data, vehicular traffic data, emission inventories, pollutant 
    measurements from previous years, concurrent pollutant measurements, 
    and meteorological data. If approval of a proposed test site is desired 
    prior to conducting the tests, a written request for approval of the 
    test site or sites must be submitted prior to conducting the tests and 
    must include the supporting and justification information required. The 
    Administrator may exercise discretion in selecting a different site (or 
    sites) for any additional tests the Administrator decides to conduct.
        (2) Methods for SO2, CO, O3, and 
    NO2. All test measurements are to be made at the same test 
    site. If necessary, the concentration of pollutant in the sampled 
    ambient air may be augmented with artificially generated pollutant to 
    facilitate measurements in the specified ranges described under 
    paragraph (d)(2) of this section.
        (3) Methods for Pb. Test measurements may be made at any number of 
    test sites. Augmentation of pollutant concentrations is not permitted, 
    hence an appropriate test site or sites must be selected to provide 
    lead concentrations in the specified range.
        (4) Methods for PM10. Test measurements must be made, or 
    derived from particulate samples collected, at not less than two test 
    sites, each of which must be located in a geographical area 
    characterized by ambient particulate matter that is significantly 
    different in nature and composition from that at the other test 
    site(s). Augmentation of pollutant concentrations is not permitted, 
    hence appropriate test sites must be selected to provide 
    PM10 concentrations in the specified range. The tests at the 
    two sites may be conducted in different calendar seasons, if 
    appropriate, to provide PM10 concentrations in the specified 
    ranges.
        (5) Methods for PM2.5. Augmentation of pollutant 
    concentrations is not permitted, hence appropriate test sites must be 
    selected to provide PM2.5 concentrations and 
    PM2.5/PM10 ratios (if applicable) in the 
    specified ranges.
        (i) Where only one test site is required, as specified in Table C-4 
    of this subpart, the site need only meet the PM2.5 ambient 
    concentration levels required by Sec. 53.34(c)(3).
        (ii) Where two sites are required, as specified in Table C-4 of 
    this subpart, each site must be selected to provide the ambient 
    concentration levels required by Sec. 53.34(c)(3). In addition, one 
    site must be selected such that all acceptable test sample sets, as 
    defined in Sec. 53.34(c)(3), have a PM2.5/PM10 
    ratio of more than 0.75; the other site must be selected such that all 
    acceptable test sample sets, as defined in Sec. 53.34(c)(3), have a 
    PM2.5/PM10 ratio of less than 0.40. At least two 
    reference method PM10 samplers shall be collocated with the 
    candidate and reference method PM2.5 samplers and operated 
    simultaneously with the other samplers at each test site to measure 
    concurrent ambient concentrations of PM10 to determine the 
    PM2.5/PM10 ratio for each sample set. The 
    PM2.5/PM10 ratio for each sample set shall be the 
    average of the PM2.5 concentration, as determined in 
    Sec. 53.34(c)(1), divided by the average PM10 concentration, 
    as measured by the PM10 samplers. The tests at the two sites 
    may be conducted in different calendar seasons, if appropriate, to 
    provide PM2.5 concentrations and PM2.5/
    PM10 ratios in the specified ranges.
        (c) Test atmosphere. Ambient air sampled at an appropriate test 
    site or sites shall be used for these tests. Simultaneous concentration 
    measurements shall be made in each of the concentration ranges 
    specified in Tables C-1, C-3, or C-4 of this subpart, as appropriate.
        (d) Sample collection--(1) All methods. All test concentration 
    measurements or samples shall be taken in such a way that both the 
    candidate method and the reference method receive air samples that are 
    homogenous or as nearly identical as practical.
        (2) Methods for SO2, CO, O3, and 
    NO2. Ambient air shall be sampled from a common intake and 
    distribution manifold designed to deliver homogenous air samples to 
    both methods. Precautions shall be taken in the design and construction 
    of this manifold to minimize the removal of particulates and trace 
    gases, and to ensure that identical samples reach the two methods. If 
    necessary, the concentration of pollutant in the sampled ambient air 
    may be augmented
    
    [[Page 38793]]
    
    with artificially-generated pollutant. However, at all times the air 
    sample measured by the candidate and reference methods under test shall 
    consist of not less than 80 percent ambient air by volume. Schematic 
    drawings, physical illustrations, descriptions, and complete details of 
    the manifold system and the augmentation system (if used) shall be 
    submitted.
        (3) Methods for Pb, PM10 and PM2.5. The 
    ambient air intake points of all the candidate and reference method 
    collocated samplers for lead, PM10 or PM2.5 shall 
    be positioned at the same height above the ground level, 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.
        (4) PM10 methods employing the same sampling procedure 
    as the reference method but a different analytical method. Candidate 
    methods for PM10 which employ a sampler and sample 
    collection procedure that are identical to the sampler and sample 
    collection procedure specified in the reference method, but use a 
    different analytical procedure, may be tested by analyzing common 
    samples. The common samples shall be collected according to the sample 
    collection procedure specified by the reference method and shall be 
    analyzed in accordance with the analytical procedures of both the 
    candidate method and the reference method.
        (e) Submission of test data and other information. All recorder 
    charts, calibration data, records, test results, procedural 
    descriptions and details, and other documentation obtained from (or 
    pertinent to) these tests shall be identified, dated, signed by the 
    analyst performing the test, and submitted. For candidate methods for 
    PM2.5, all submitted information must meet the requirements 
    of the ANSI/ASQC E4 Standard, sections 3.3.1, paragraphs 1 and 2 
    (Reference 1 of Appendix A of this subpart).
    
    
    Sec. 53.31   Test conditions.
    
        (a) All methods. All test measurements made or test samples 
    collected by means of a sample manifold as specified in 
    Sec. 53.30(d)(2) shall be at a room temperature between 20  deg.C and 
    30  deg.C, and at a line voltage between 105 and 125 volts. All methods 
    shall be calibrated as specified in paragraph (c) of this section prior 
    to initiation of the tests.
        (b) Samplers and automated methods. (1) Setup and start-up of the 
    test analyzer, test sampler(s), and reference method (if applicable) 
    shall be in strict accordance with the applicable operation manual(s). 
    If the test analyzer does not have an integral strip chart or digital 
    data recorder, connect the analyzer output to a suitable strip chart or 
    digital data recorder. This recorder shall have a chart width of at 
    least 25 centimeters, a response time of 1 second or less, a deadband 
    of not more than 0.25 percent of full scale, and capability of either 
    reading measurements at least 5 percent below zero or offsetting the 
    zero by at least 5 percent. Digital data shall be recorded at 
    appropriate time intervals such that trend plots similar to a strip 
    chart recording may be constructed with a similar or suitable level of 
    detail.
        (2) Other data acquisition components may be used along with the 
    chart recorder during the conduct of these tests. Use of the chart 
    recorder is intended only to facilitate visual evaluation of data 
    submitted.
        (3) Allow adequate warmup or stabilization time as indicated in the 
    applicable operation manual(s) before beginning the tests.
        (c) Calibration. The reference method shall be calibrated according 
    to the appropriate appendix to part 50 of this chapter (if it is a 
    manual method) or according to the applicable operation manual(s) (if 
    it is an automated method). A candidate manual method (or portion 
    thereof) shall be calibrated, according to the applicable operation 
    manual(s), if such calibration is a part of the method.
        (d) Range. (1) Except as provided in paragraph (d)(2) of this 
    section, each method shall be operated in the range specified for the 
    reference method in the appropriate appendix to part 50 of this chapter 
    (for manual reference methods), or specified in Table B-1 of subpart B 
    of this part (for automated reference methods).
        (2) For a candidate method having more than one selectable range, 
    one range must be that specified in Table B-1 of subpart B of this part 
    and a test analyzer representative of the method must pass the tests 
    required by this subpart while operated on that range. The tests may be 
    repeated for a broader range (i.e., one extending to higher 
    concentrations) than the one specified in Table B-1 of subpart B of 
    this part, provided that the range does not extend to concentrations 
    more than two times the upper range limit specified in Table B-1 of 
    subpart B of this part and that the test analyzer has passed the tests 
    required by subpart B of this part (if applicable) for the broader 
    range. If the tests required by this subpart are conducted or passed 
    only for the range specified in Table B-1 of subpart B of this part, 
    any equivalent method determination with respect to the method will be 
    limited to that range. If the tests are passed for both the specified 
    range and a broader range (or ranges), any such determination will 
    include the broader range(s) as well as the specified range. 
    Appropriate test data shall be submitted for each range sought to be 
    included in such a determination.
        (e) Operation of automated methods. (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 
    Sec. 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.
        (2) All test measurements shall be made with the same test 
    analyzer; use of multiple test analyzers is not permitted. The test 
    analyzer shall be operated continuously during the entire series of 
    test measurements.
        (3) If a test analyzer should malfunction during any of these 
    tests, the entire set of measurements shall be repeated, and a detailed 
    explanation of the malfunction, remedial action taken, and whether 
    recalibration was necessary (along with all pertinent records and 
    charts) shall be submitted.
    
    
    Sec. 53.32   Test procedures for methods for SO2, CO, 
    O3, and NO2.
    
        (a) Conduct the first set of simultaneous measurements with the 
    candidate and reference methods:
        (1) Table C-1 of this subpart specifies the type (1- or 24-hour) 
    and number of measurements to be made in each of the three test 
    concentration ranges.
        (2) The pollutant concentration must fall within the specified 
    range as measured by the reference method.
        (3) The measurements shall be made in the sequence specified in 
    Table C-2 of this subpart, except for the 1-hour SO2 
    measurements, which are all in the high range.
        (b) For each pair of measurements, determine the difference 
    (discrepancy) between the candidate method measurement and reference 
    method measurement. A discrepancy which exceeds the discrepancy 
    specified in Table C-1 of this subpart constitutes a failure. Figure C-
    1 of this subpart contains a suggested format for reporting the test 
    results.
        (c) The results of the first set of measurements shall be 
    interpreted as follows:
    
    [[Page 38794]]
    
        (1) Zero failures. The candidate method passes the test for 
    comparability.
        (2) Three or more failures. The candidate method fails the test for 
    comparability.
        (3) One or two failures. Conduct a second set of simultaneous 
    measurements as specified in Table C-1 of this subpart. The results of 
    the combined total of first-set and second-set measurements shall be 
    interpreted as follows:
        (i) One or two failures. The candidate method passes the test for 
    comparability.
        (ii) Three or more failures. The candidate method fails the test 
    for comparability.
        (4) For SO2, the 1-hour and 24-hour measurements shall 
    be interpreted separately, and the candidate method must pass the tests 
    for both 1- and 24-hour measurements to pass the test for 
    comparability.
        (d) A 1-hour measurement consists of the integral of the 
    instantaneous concentration over a 60-minute continuous period divided 
    by the time period. Integration of the instantaneous concentration may 
    be performed by any appropriate means such as chemical, electronic, 
    mechanical, visual judgment, or by calculating the mean of not less 
    than 12 equally spaced instantaneous readings. Appropriate allowances 
    or corrections shall be made in cases where significant errors could 
    occur due to characteristic lag time or rise/fall time differences 
    between the candidate and reference methods. Details of the means of 
    integration and any corrections shall be submitted.
        (e) A 24-hour measurement consists of the integral of the 
    instantaneous concentration over a 24-hour continuous period divided by 
    the time period. This integration may be performed by any appropriate 
    means such as chemical, electronic, mechanical, or by calculating the 
    mean of 24 sequential 1-hour measurements.
        (f) For ozone and carbon monoxide, no more than six 1-hour 
    measurements shall be made per day. For sulfur dioxide, no more than 
    four 1-hour measurements or one 24-hour measurement shall be made per 
    day. One-hour measurements may be made concurrently with 24-hour 
    measurements if appropriate.
        (g) For applicable methods, control or calibration checks may be 
    performed once per day without adjusting the test analyzer or method. 
    These checks may be used as a basis for a linear interpolation-type 
    correction to be applied to the measurements to correct for drift. If 
    such a correction is used, it shall be applied to all measurements made 
    with the method, and the correction procedure shall become a part of 
    the method.
    
    
    Sec. 53.33   Test procedure for methods for lead.
    
        (a) Sample collection. Collect simultaneous 24-hour samples 
    (filters) of lead at the test site or sites with both the reference and 
    candidate methods until at least 10 filter pairs have been obtained. If 
    the conditions of Sec. 53.30(d)(4) apply, collect at least 10 common 
    samples (filters) in accordance with Sec. 53.30(d)(4) and divide each 
    to form the filter pairs.
        (b) Audit samples. Three audit samples must be obtained from the 
    address given in Sec. 53.4(a). The audit samples are 3/4 x 8-inch glass 
    fiber strips containing known amounts of lead at the following nominal 
    levels: 100 g/strip; 300 g/strip; 750 g/
    strip. The true amount of lead, in total g/strip, will be 
    provided with each audit sample.
        (c) Filter analysis. (1) For both the reference method samples and 
    the audit samples, analyze each filter extract three times in 
    accordance with the reference method analytical procedure. The analysis 
    of replicates should not be performed sequentially, i.e., a single 
    sample should not be analyzed three times in sequence. Calculate the 
    indicated lead concentrations for the reference method samples in 
    g/m3 for each analysis of each filter. Calculate 
    the indicated total lead amount for the audit samples in g/
    strip for each analysis of each strip. Label these test results as 
    R1A, R1B, R1C, R2A, 
    R2B, ..., Q1A, Q1B, Q1C, 
    ..., where R denotes results from the reference method samples; Q 
    denotes results from the audit samples; 1, 2, 3 indicate the filter 
    number, and A, B, C indicate the first, second, and third analysis of 
    each filter, respectively.
        (2) For the candidate method samples, analyze each sample filter or 
    filter extract three times and calculate, in accordance with the 
    candidate method, the indicated lead concentrates in g/m3 
    for each analysis of each filter. Label these test results as 
    C1A, C1B, C2C, ..., where C denotes 
    results from the candidate method. For candidate methods which provide 
    a direct measurement of lead concentrations without a separable 
    procedure, C1A=C1B=C1C, 
    C2A=C2B=C2C, etc.
        (d) Average lead concentration. For the reference method, calculate 
    the average lead concentration for each filter by averaging the 
    concentrations calculated from the three analyses:
    
    Equation 1
    [GRAPHIC] [TIFF OMITTED] TR18JY97.052
    
    where:
    i is the filter number.
    
        (e) Acceptable filter pairs. Disregard all filter pairs for which 
    the lead concentration as determined in the previous paragraph (d) of 
    this section by the average of the three reference method 
    determinations, falls outside the range of 0.5 to 4.0 g/
    m3. All remaining filter pairs must be subjected to both of 
    the following tests for precision and comparability. At least five 
    filter pairs must be within the 0.5 to 4.0 g/m3 
    range for the tests to be valid.
        (f) Test for precision. (1) Calculate the precision (P) of the 
    analysis (in percent) for each filter and for each method, as the 
    maximum minus the minimum divided by the average of the three 
    concentration values, as follows:
    
    Equation 2
    [GRAPHIC] [TIFF OMITTED] TR18JY97.053
    
        or
    
    Equation 3
    [GRAPHIC] [TIFF OMITTED] TR18JY97.054
    
    where:
    i indicates the filter number.
        (2) If any reference method precision value (PRi) 
    exceeds 15 percent, the precision of the reference method analytical 
    procedure is out of control. Corrective action must be taken to 
    determine the source(s) of imprecision and the reference method 
    determinations must be repeated according to paragraph (c) of this 
    section, or the entire test procedure (starting with paragraph (a) of 
    this section) must be repeated.
        (3) If any candidate method precision value (PCi) 
    exceeds 15 percent, the candidate method fails the precision test.
        (4) The candidate method passes this test if all precision values 
    (i.e., all PRi's and all PCi's) are less than 15 
    percent.
        (g) Test for accuracy. (1)(i) For the audit samples calculate the 
    average lead concentration for each strip by averaging the 
    concentrations calculated from the three analyses:
    
    Equation 4
    [GRAPHIC] [TIFF OMITTED] TR18JY97.055
    
    where:
    i is audit sample number.
    
    [[Page 38795]]
    
        (ii) Calculate the percent difference (Dq) between the 
    indicated lead concentration for each audit sample and the true lead 
    concentration (Tq) as follows:
    
    Equation 5
    [GRAPHIC] [TIFF OMITTED] TR18JY97.056
    
        (2) If any difference value (Dqi) exceeds 5 
    percent, the accuracy of the reference method analytical procedure is 
    out of control. Corrective action must be taken to determine the source 
    of the error(s) (e.g., calibration standard discrepancies, extraction 
    problems, etc.) and the reference method and audit sample 
    determinations must be repeated according to paragraph (c) of this 
    section, or the entire test procedure (starting with paragraph (a) of 
    this section) must be repeated.
        (h) Test for comparability. (1) For each filter pair, calculate all 
    nine possible percent differences (D) between the reference and 
    candidate methods, using all nine possible combinations of the three 
    determinations (A, B, and C) for each method, as:
    
    Equation 6
    [GRAPHIC] [TIFF OMITTED] TR18JY97.057
    
    where:
    i is the filter number, and n numbers from 1 to 9 for the nine 
    possible difference combinations for the three determinations for 
    each method (j= A, B, C, candidate; k= A, B, C, reference).
        (2) If none of the percent differences (D) exceeds  20 
    percent, the candidate method passes the test for comparability.
        (3) If one or more of the percent differences (D) exceeds 
     20 percent, the candidate method fails the test for 
    comparability.
        (i) The candidate method must pass both the precision test 
    (paragraph (f) of this section) and the comparability test (paragraph 
    (h) of this section) to qualify for designation as an equivalent 
    method.
    
    
    Sec. 53.34   Test procedure for methods for PM10 and 
    PM2.5.
    
        (a) Collocated measurements. Set up three reference method samplers 
    collocated with three candidate method samplers or analyzers at each of 
    the number of test sites specified in Table C-4 of this subpart. At 
    each site, obtain as many sets of simultaneous PM10 or 
    PM2.5 measurements as necessary (see paragraph (c)(3) of 
    this section), each set consisting of three reference method and three 
    candidate method measurements, all obtained simultaneously. For 
    PM2.5 candidate Class II equivalent methods, at least two 
    collocated PM10 reference method samplers are also required 
    to obtain PM2.5/PM10 ratios for each sample set. 
    Candidate PM10 method measurements shall be 24-hour 
    integrated measurements; PM2.5 measurements may be either 
    24- or 48-hour integrated measurements. All collocated measurements in 
    a sample set must cover the same 24- or 48-hour time period. For 
    samplers, retrieve the samples promptly after sample collection and 
    analyze each sample according to the reference method or candidate 
    method, as appropriate, and determine the PM10 or 
    PM2.5 concentration in g/m3. If the 
    conditions of Sec. 53.30(d)(4) apply, collect sample sets only with the 
    three reference method samplers. Guidance for quality assurance 
    procedures for PM2.5 methods is found in section 2.12 of the 
    Quality Assurance Handbook (Reference 6 of Appendix A to subpart A of 
    this part).
        (b) Sequential samplers. For sequential samplers, the sampler shall 
    be configured for the maximum number of sequential samples and shall be 
    set for automatic collection of all samples sequentially such that the 
    test samples are collected equally, to the extent possible, among all 
    available sequential channels or utilizing the full available 
    sequential capability.
        (c) Test for comparability and precision. (1) For each of the 
    measurement sets, calculate the average PM10 or 
    PM2.5 concentration obtained with the reference method 
    samplers:
    
    Equation 7
    [GRAPHIC] [TIFF OMITTED] TR18JY97.058
    
    where:
    R denotes results from the reference method;
    i is the sampler number; and
    j is the set.
        (2)(i)(A) For each of the measurement sets, calculate the precision 
    of the reference method PM10 or PM2.5 
    measurements as:
    
    Equation 8
    [GRAPHIC] [TIFF OMITTED] TR18JY97.059
    
        (B) If the corresponding j is below:
        80 g/m3 for PM10 methods.
        40 g/m3 for 24-hour PM2.5 at 
    single test sites for Class I candidate methods.
        40 g/m3 for 24-hour PM2.5 at 
    sites having PM2.5/PM10 ratios >0.75.
        30 g/m3 for 48-hour PM2.5 at 
    single test sites for Class I candidate methods.
        30 g/m3 for 48-hour PM2.5 at 
    sites having PM2.5/PM10 ratios >0.75.
        30 g/m3 for 24-hour PM2.5 at 
    sites having PM2.5/PM10 ratios <0.40. 20="">g/m3 for 48-hour PM2.5 at 
    sites having PM2.5/PM10 ratios >0.75.
    
        (ii) Otherwise, calculate the precision of the reference method 
    PM10 or PM2.5 measurements as:
    
    Equation 9
    [GRAPHIC] [TIFF OMITTED] TR18JY97.060
    
        (3) If j falls outside the acceptable concentration range specified 
    in Table C-4 of this subpart for any set, or if Pj or RPj, as 
    applicable, exceeds the value specified in Table C-4 of this subpart 
    for any set, that set of measurements shall be discarded. For each 
    site, Table C-4 of this subpart specifies the minimum number of sample 
    sets required for various conditions, and Sec. 53.30(b)(5) specifies 
    the PM2.5/PM10 ratio requirements applicable to 
    Class II candidate equivalent methods. Additional measurement sets 
    shall be collected and analyzed, as necessary, to provide a minimum of 
    10 acceptable measurement sets for each test site. If more than 10 
    measurement sets are collected that meet the above criteria, all such 
    measurement sets shall be used to demonstrate comparability.
        (4) For each of the acceptable measurement sets, calculate the 
    average PM10 or PM2.5 concentration obtained with 
    the candidate method samplers:
    
    Equation 10
    [GRAPHIC] [TIFF OMITTED] TR18JY97.061
    
    where:
    C denotes results from the candidate method;
    i is the sampler number; and
    j is the set.
    
        (5) For each site, plot the average PM10 or 
    PM2.5 measurements obtained with the candidate method 
    (Cj) against the corresponding average PM10 or 
    PM2.5 measurements obtained with the reference method 
    (Rj). For each site, calculate and record the linear 
    regression slope and intercept, and the correlation coefficient.
        (6) If the linear regression parameters calculated under paragraph 
    (c)(5) of this section meet the values specified in Table C-4 of this 
    subpart for all test sites, the candidate method passes the test for 
    comparability.
    
    [[Page 38796]]
    
    Tables to Subpart C of Part 53
    
                          Table C-1.--Test Concentration Ranges, Number of Measurements Required, and Maximum Discrepancy Specification                     
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Simultaneous Measurements Required               Maximum    
                                                                                       ----------------------------------------------------    Discrepancy  
                   Pollutant                   Concentration Range Parts per Million              1-hr                      24-hr            Specification, 
                                                                                       ----------------------------------------------------     Parts per   
                                                                                         First Set    Second Set   First Set    Second Set       Million    
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Ozone.................................  Low 0.06 to 0.10..........................            5            6  ...........  ...........              0.02
                                            Med 0.15 to 0.25..........................            5            6  ...........  ...........               .03
                                            High 0.35 to 0.45.........................            4            6  ...........  ...........               .04
                                                                                       ---------------------------------------------------------------------
                                               Total..................................           14           18  ...........  ...........  ................
                                                                                       =====================================================================
    Carbon Monoxide.......................  Low 7 to 11...............................            5            6  ...........  ...........               1.5
                                            Med 20 to 30..............................            5            6  ...........  ...........               2.0
                                            High 35 to 45.............................            4            6  ...........  ...........               3.0
                                                                                       ---------------------------------------------------------------------
                                               Total..................................           14           18  ...........  ...........  ................
                                                                                       =====================================================================
    Sulfur Dioxide........................  Low 0.02 to 0.05..........................  ...........  ...........            3            3              0.02
                                            Med 0.10 to 0.15..........................  ...........  ...........            2            3               .03
                                            High 0.30 to 0.50.........................            7            8            2            2               .04
                                                                                       ---------------------------------------------------------------------
                                               Total..................................            7            8            7            8  ................
                                                                                       =====================================================================
    Nitrogen Dioxide......................  Low 0.02 to 0.08..........................  ...........  ...........            3            3              0.02
                                            Med 0.10 to 0.20..........................  ...........  ...........            2            3               .03
                                            High 0.25 to 0.35.........................  ...........  ...........            2            2               .03
                                                                                       ---------------------------------------------------------------------
                                               Total..................................  ...........  ...........            7            8  ................
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    
                    Table C-2.--Sequence of Test Measurements               
    ------------------------------------------------------------------------
                                               Concentration Range          
              Measurement           ----------------------------------------
                                          First Set           Second Set    
    ------------------------------------------------------------------------
    1..............................  Low                 Medium             
    2..............................  High                High               
    3..............................  Medium              Low                
    4..............................  High                High               
    5..............................  Low                 Medium             
    6..............................  Medium              Low                
    7..............................  Low                 Medium             
    8..............................  Medium              Low                
    9..............................  High                High               
    10.............................  Medium              Low                
    11.............................  High                Medium             
    12.............................  Low                 High               
    13.............................  Medium              Medium             
    14.............................  Low                 High               
    15.............................                      Low                
    16.............................                      Medium             
    17.............................                      Low                
    18.............................                      High               
    ------------------------------------------------------------------------
    
    
    
                Table C-3.--Test Specifications for Lead Methods            
    ------------------------------------------------------------------------
                                                                            
    ------------------------------------------------------------------------
    Concentration range, g/m\3\..........................   0.5-4.0
    Minimum number of 24-hr measurements..........................         5
    Maximum analytical precision, percent.........................         5
    Maximum analytical accuracy, percent..........................  10 and PM2.5 Methods                           
    ----------------------------------------------------------------------------------------------------------------
                                                                                        PM2.5                       
             Specification                      PM10           -----------------------------------------------------
                                                                         Class I                    Class II        
    ----------------------------------------------------------------------------------------------------------------
    Acceptable concentration range   30-300...................  10-200...................  10-200                   
     (Rj), g/m3.                                                                                           
    Minimum number of test sites...  2........................  1........................  2                        
    Number of candidate method       3........................  3........................  3                        
     samplers per site.                                                                                             
    Number of reference method       3........................  3........................  3                        
     samplers per site.                                                                                             
    Minimum number of acceptable                                                                                    
     sample sets per site for PM10:                                                                                 
        Rj < 80="">g/m3......  3........................  .........................  .........................
        Rj > 80 g/m3......  3........................  .........................  .........................
            Total..................  10.......................  .........................  .........................
    Minimum number of acceptable                                                                                    
     sample sets per site for                                                                                       
     PM2.5:                                                                                                         
        Single test site for Class                                                                                  
         I candidate equivalent                                                                                     
         methods:                                                                                                   
            Rj < 40="">g/m3      .......................  3........................  .........................
             for 24-hr or Rj < 30="">g/m3 for 48-                                                                                  
             hr samples.                                                                                            
            Rj > 40 g/m3      .......................  3........................  .........................
             for 24-hr or Rj > 30                                                                                   
             g/m3 for 48-                                                                                  
             hr samples.                                                                                            
        Sites at which the PM2.5/                                                                                   
         PM10 ratio must be > 0.75:                                                                                 
            Rj < 40="">g/m3      .......................  .........................  3                        
             for 24-hr or Rj < 30="">g/m3 for 48-                                                                                  
             hr samples.                                                                                            
            Rj > 40 g/m3      .......................  .........................  3                        
             for 24-hr or Rj > 30                                                                                   
             g/m3 for 48-                                                                                  
             hr samples.                                                                                            
        Sites at which the PM2.5/                                                                                   
         PM10 ratio must be < 0.40:="">j < 30="">g/m3      .......................  .........................  3                        
             for 24-hr or Rj < 20="">g/m3 for 48-                                                                                  
             hr samples.                                                                                            
    
    [[Page 38797]]
    
                                                                                                                    
            Rj > 30 g/m3      .......................  .........................  3                        
             for 24-hr or Rj > 20                                                                                   
             g/m3 for 48-                                                                                  
             hr samples.                                                                                            
    Total, each site...............    .......................  10.......................  10                       
    Precision of replicate           5 g/m3 or 7%....  2 g/m3 or 5%....  2 g/m3 or 5%    
     reference method measurements,                                                                                 
     Pj or RPj respectively,                                                                                        
     maximum.                                                                                                       
    Slope of regression              10.1.........  10.05........  10.05        
     relationship.                                                                                                  
    Intercept of regression          05...........  01...........  01           
     relationship, g/m3.                                                                                   
    Correlation of reference method  0.97..........  0.97..........  0.97          
     and candidate method                                                                                           
     measurements.                                                                                                  
    ----------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38798]]
    
    Figures to Subpart C of Part 53
    
                                                                        Figure C-1.--Suggested Format for Reporting Test Results                                                                    
                                                              Candidate Method------------------------------------------------------------                                                          
                                                              Reference Method------------------------------------------------------------                                                          
                                                             Applicant----------------------------------------------------------------------                                                        
                                                                        First Set      Second Set      Type     1 Hour      24 Hour                                                                 
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Concentration, ppm                                                                      
           Concentration Range                                   Date                Time        ----------------------------------------     Difference        Table C-1 Spec.      Pass or Fail   
                                                                                                       Candidate           Reference                                                                
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                   Low                1                                                                                                                                                             
             ---------- ppm                                                                                                                                                                         
             to -------- ppm                                                                                                                                                                        
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      2                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      3                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      4                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      5                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      6                                                                                                                                                             
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                 Medium               1                                                                                                                                                             
             ---------- ppm                                                                                                                                                                         
             to -------- ppm                                                                                                                                                                        
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      2                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      3                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      4                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      5                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      6                                                                                                                                                             
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                  High                1                                                                                                                                                             
             ---------- ppm                                                                                                                                                                         
             to -------- ppm                                                                                                                                                                        
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      2                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      3                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      4                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      5                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      6                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      7                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                      8                                                                                                                                                             
                                     ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                              Total                                 
                                                                                                                                                              Failures:                             
    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38799]]
    
    Appendix A to Subpart C of Part 53--References
        (1) American National Standard--Specifications and Guidelines 
    for Quality Systems for Environmental Data Collection and 
    Environmental Technology Programs, ANSI/ASQC E4-1994. Available from 
    American Society for Quality Control, 611 East Wisconsin Avenue, 
    Milwaukee, WI 53202.
        d. Subpart E is added to read as follows:
    Subpart E--Procedures for Testing Physical (Design) and Performance 
    Characteristics of Reference Methods and Class I Equivalent Methods for 
    PM2.5
    Sec.
    53.50   General provisions.
    53.51   Demonstration of compliance with design specifications and 
    manufacturing and test requirements.
    53.52   Leak check test.
    53.53   Test for flow rate accuracy, regulation, measurement 
    accuracy, and cut-off.
    53.54   Test for proper sampler operation following power 
    interruptions.
    53.55   Test for effect of variations in power line voltage and 
    ambient temperature.
    53.56   Test for effect of variations in ambient pressure.
    53.57   Test for filter temperature control during sampling and 
    post-sampling periods.
    53.58   Operational field precision and blank test.
    53.59   Aerosol transport test for Class I equivalent method 
    samplers.
    Tables to Subpart E of Part 53
    Table E-1.--Summary of Test Requirements for Reference and Class I 
    Equivalent Methods for PM2.5.
    Table E-2.--Spectral Energy Distribution and Permitted Tolerance for 
    Conducting Radiative Tests.
    Figures to Subpart E of Part 53
    Figure E-1--Designation Testing Checklist
    Figure E-2--Product Manufacturing Checklist
    Appendix A to Subpart E of Part 53--References
    
    Subpart E--Procedures for Testing Physical (Design) and Performance 
    Characteristics of Reference Methods and Class I Equivalent Methods 
    for PM2.5
    
    
    Sec. 53.50   General provisions.
    
        (a) 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 PM2.5 
    sampler associated with a candidate reference method or Class I 
    equivalent method meets all design and performance specifications set 
    forth in 40 CFR part 50, Appendix L, as well as additional requirements 
    specified in this subpart E. Some of these tests may also be applicable 
    to portions of a candidate Class II equivalent method sampler, as 
    determined under subpart F of this part. Some or all of these tests may 
    also be applicable to a candidate Class III equivalent method sampler, 
    as may be determined under Sec. 53.3(a)(4) or Sec. 53.3(b)(3).
        (b) Samplers associated with candidate reference methods for 
    PM2.5 shall be subject to the provisions, specifications, 
    and test procedures prescribed in Secs. 53.51 through 53.58. Samplers 
    associated with candidate Class I equivalent methods for 
    PM2.5 shall be subject to the provisions, specifications, 
    and test procedures prescribed in all sections of this subpart. 
    Samplers associated with candidate Class II equivalent methods for 
    PM2.5 shall be subject to the provisions, specifications, 
    and test procedures prescribed in all applicable sections of this 
    subpart, as specified in subpart F of this part.
        (c) The provisions of Sec. 53.51 pertain to test results and 
    documentation required to demonstrate compliance of a candidate method 
    sampler with the design specifications set forth in 40 CFR part 50, 
    Appendix L. The test procedures prescribed in Secs. 53.52 through 53.59 
    pertain to performance tests required to demonstrate compliance of a 
    candidate method sampler with the performance specifications set forth 
    in 40 CFR part 50, Appendix L, as well as additional requirements 
    specified in this subpart E. These latter test procedures shall be used 
    to test the performance of candidate samplers against the performance 
    specifications and requirements specified in each procedure and 
    summarized in Table E-1 of this subpart.
        (d) Test procedures prescribed in Sec. 53.59 do not apply to 
    candidate reference method samplers. These procedures apply primarily 
    to candidate Class I equivalent method samplers for PM2.5 
    which have a sample air flow path configuration upstream of the sample 
    filter that is modified with respect to that specified for the 
    reference method sampler, as set forth in 40 CFR part 50, Appendix L, 
    Figures L-1 to L-29, such as might be necessary to provide for 
    sequential sample capability. The additional tests determine the 
    adequacy of aerosol transport through any altered components or 
    supplemental devices that are used in a candidate sampler upstream of 
    the sample filter. In addition to the other test procedures in this 
    subpart, these test procedures shall be used to further test the 
    performance of such an equivalent method sampler against the 
    performance specifications given in the procedure and summarized in 
    Table E-1 of this subpart.
        (e) A 10-day operational field test of measurement precision is 
    required under Sec. 53.58 for both candidate reference and equivalent 
    method samplers. This test requires collocated operation of three 
    candidate method samplers at a field test site. For candidate 
    equivalent method samplers, this test may be combined and carried out 
    concurrently with the test for comparability to the reference method 
    specified under Sec. 53.34, which requires collocated operation of 
    three reference method samplers and three candidate equivalent method 
    samplers.
        (f) All tests and collection of test data shall be performed in 
    accordance with the requirements of Reference 1, section 4.10.5 (ISO 
    9001) and Reference 2, Part B, section 3.3.1, paragraphs 1 and 2 and 
    Part C, section 4.6 (ANSI/ASQC E4) in Appendix A of this subpart. All 
    test data and other documentation obtained specifically from or 
    pertinent to these tests shall be identified, dated, signed by the 
    analyst performing the test, and submitted to EPA in accordance with 
    subpart A of this part.
    
    
    Sec. 53.51   Demonstration of compliance with design specifications and 
    manufacturing and test requirements.
    
        (a) Overview. (1) The subsequent paragraphs of this section specify 
    certain documentation that must be submitted and tests that are 
    required to demonstrate that samplers associated with a designated 
    reference or equivalent method for PM2.5 are properly 
    manufactured to meet all applicable design and performance 
    specifications and have been properly tested according to all 
    applicable test requirements for such designation. Documentation is 
    required to show that instruments and components of a PM2.5 
    sampler are manufactured in an ISO 9001-registered facility under a 
    quality system that meets ISO-9001 requirements for manufacturing 
    quality control and testing.
        (2) In addition, specific tests are required to verify that two 
    critical features of reference method samplers impactor jet diameter 
    and the surface finish of surfaces specified to be anodized meet the 
    specifications of 40 CFR part 50, Appendix L. A checklist is required 
    to provide certification by an ISO-certified auditor that all 
    performance and other required tests have been properly and 
    appropriately conducted, based on a reasonable and appropriate sample 
    of the actual operations or their documented records. Following 
    designation of the method, another checklist is required, initially
    
    [[Page 38800]]
    
    and annually, to provide an ISO-certified auditor's certification that 
    the sampler manufacturing process is being implemented under an 
    adequate and appropriate quality system.
        (3) For the purposes of this section, the definitions of ISO 9001-
    registered facility and ISO-certified auditor are found in Sec. 53.1. 
    An exception to the reliance by EPA on ISO affiliate audits 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 Sec. 53.4(b)(3). EPA has determined that 
    acceptable technical judgment for review of this manual may not be 
    assured by ISO affiliates, and approval of this manual will therefore 
    be performed by EPA.
        (b) ISO registration of manufacturing facility. (1) The applicant 
    must submit documentation verifying that the samplers identified and 
    sold as part of a designated PM2.5 reference or equivalent 
    method will be manufactured in an ISO 9001-registered facility and that 
    the manufacturing facility is maintained in compliance with all 
    applicable ISO 9001 requirements (Reference 1 in Appendix A of this 
    subpart). The documentation shall indicate the date of the original ISO 
    9001 registration for the facility and shall include a copy of the most 
    recent certification of continued ISO 9001 facility registration. If 
    the manufacturer does not wish to initiate or complete ISO 9001 
    registration for the manufacturing facility, documentation must be 
    included in the application to EPA describing an alternative method to 
    demonstrate that the facility meets the same general requirements as 
    required for registration to ISO-9001. In this case, the applicant must 
    provide documentation in the application to demonstrate, by required 
    ISO-certified auditor's inspections, that a quality system is in place 
    which is adequate to document and monitor that the sampler system 
    components and final assembled samplers all conform to the design, 
    performance and other requirements specified in this part and in 40 CFR 
    part 50, Appendix L.
        (2) Phase-in period. For a period of 1 year following the effective 
    date of this subpart, a candidate reference or equivalent method for 
    PM2.5 that utilizes a sampler manufactured in a facility 
    that is not ISO 9001-registered or otherwise approved by EPA under 
    paragraph (b)(1) of this section may be conditionally designated as a 
    reference or equivalent method under this part. Such conditional 
    designation will be considered on the basis of evidence submitted in 
    association with the candidate method application showing that 
    appropriate efforts are currently underway to seek ISO 9001 
    registration or alternative approval of the facility's quality system 
    under paragraph (b)(1) of this section within the next 12 months. Such 
    conditional designation shall expire 1 year after the date of the 
    Federal Register notice of the conditional designation unless 
    documentation verifying successful ISO 9001 registration for the 
    facility or other EPA-acceptable quality system review and approval 
    process of the production facility that will manufacture the samplers 
    is submitted at least 30 days prior to the expiration date.
        (c) Sampler manufacturing quality control. The manufacturer must 
    ensure that all components used in the manufacture of PM2.5 
    samplers to be sold as part of a reference or equivalent method and 
    that are specified by design in 40 CFR part 50, Appendix L, are 
    fabricated or manufactured exactly as specified. If the manufacturer's 
    quality records show that its quality control (QC) and quality 
    assurance (QA) system of standard process control inspections (of a set 
    number and frequency of testing that is less than 100 percent) complies 
    with the applicable QA provisions of section 4 of Reference 4 in 
    Appendix A of this subpart and prevents nonconformances, 100 percent 
    testing shall not be required until that conclusion is disproved by 
    customer return or other independent manufacturer or customer test 
    records. If problems are uncovered, inspection to verify conformance to 
    the drawings, specifications, and tolerances shall be performed. Refer 
    also to paragraph (e) of this section--final assembly and inspection 
    requirements.
        (d) Specific tests and supporting documentation required to verify 
    conformance to critical component specifications.--(1) Verification of 
    PM2.5 impactor jet diameter. The diameter of the jet of each 
    impactor manufactured for a PM2.5 sampler under the impactor 
    design specifications set forth in 40 CFR part 50, Appendix L, shall be 
    verified against the tolerance specified on the drawing, using 
    standard, NIST-traceable ZZ go/no go plug gages. This test shall be a 
    final check of the jet diameter following all fabrication operations, 
    and a record shall be kept of this final check. The manufacturer shall 
    submit evidence that this procedure is incorporated into the 
    manufacturing procedure, that the test is or will be routinely 
    implemented, and that an appropriate procedure is in place for the 
    disposition of units that fail this tolerance test.
        (2) Verification of surface finish. The anodization process used to 
    treat surfaces specified to be anodized shall be verified by testing 
    treated specimen surfaces for weight and corrosion resistance to ensure 
    that the coating obtained conforms to the coating specification. The 
    specimen surfaces shall be finished in accordance with military 
    standard specification 8625F, Type II, Class I (Reference 4 in Appendix 
    A of this subpart) in the same way the sampler surfaces are finished, 
    and tested, prior to sealing, as specified in section 4.5.2 of 
    Reference 4 in Appendix A of this subpart.
        (e) Final assembly and inspection requirements. Each sampler shall 
    be tested after manufacture and before delivery to the final user. Each 
    manufacturer shall document its post-manufacturing test procedures. As 
    a minimum, each test shall consist of the following: Tests of the 
    overall integrity of the sampler, including leak tests; calibration or 
    verification of the calibration of the flow measurement device, 
    barometric pressure sensor, and temperature sensors; and operation of 
    the sampler with a filter in place over a period of at least 48 hours. 
    The results of each test shall be suitably documented and shall be 
    subject to review by an ISO-certified auditor.
        (f) Manufacturer's audit checklists. Manufacturers shall require an 
    ISO-certified auditor to sign and date a statement indicating that the 
    auditor is aware of the appropriate manufacturing specifications 
    contained in 40 CFR part 50, Appendix L, and the test or verification 
    requirements in this subpart. Manufacturers shall also require an ISO-
    certified auditor to complete the checklists, shown in Figures E-1 and 
    E-2 of this subpart, which describe the manufacturer's ability to meet 
    the requirements of the standard for both designation testing and 
    product manufacture.
        (1) Designation testing checklist. The completed statement and 
    checklist as shown in Figure E-1 of this subpart shall be submitted 
    with the application for reference or equivalent method determination.
        (2) Product manufacturing checklist. Manufacturers shall require an 
    ISO-certified auditor to complete a Product Manufacturing Checklist 
    (Figure E-2 of this subpart), which evaluates the manufacturer on its 
    ability to meet the requirements of the standard in maintaining quality 
    control in the production of reference or equivalent devices. The 
    initial completed checklist shall be submitted with the application for 
    reference or equivalent method determination. Also, this checklist 
    (Figure E-2 of this subpart) must be completed and submitted annually 
    to
    
    [[Page 38801]]
    
    retain a reference or equivalent method designation for a 
    PM2.5 method.
        (3) Phase-in period. If the conditions of paragraph (b)(2) of this 
    section apply, a candidate reference or equivalent method for 
    PM2.5 may be conditionally designated as a reference or 
    equivalent method under this part 53 without the submission of the 
    checklists described in paragraphs (f)(1) and (f)(2) of this section. 
    Such conditional designation shall expire 1 year after the date of the 
    Federal Register notice of the conditional designation unless the 
    checklists are submitted at least 30 days prior to the expiration date.
    
    
    Sec. 53.52   Leak check test.
    
        (a) Overview. In section 7.4.6 of 40 CFR part 50, Appendix L, the 
    sampler is required to include the facility, including components, 
    instruments, operator controls, a written procedure, and other 
    capabilities as necessary, to allow the operator to carry out a leak 
    test of the sampler at a field monitoring site without additional 
    equipment. This test procedure is intended to test the adequacy and 
    effectiveness of the sampler's leak check facility. Because of the 
    variety of potential sampler configurations and leak check procedures 
    possible, some adaptation of this procedure may be necessary to 
    accommodate the specific sampler under test. The test conditions and 
    performance specifications associated with this test are summarized in 
    Table E-1 of this subpart. The candidate test sampler must meet all 
    test parameters and test specifications to successfully pass this test.
        (b) Technical definitions. (1) External leakage includes the total 
    flow rate of external ambient air which enters the sampler other than 
    through the sampler inlet and which passes through any one or more of 
    the impactor, filter, or flow rate measurement components.
        (2) Internal leakage is the total sample air flow rate that passes 
    through the filter holder assembly without passing through the sample 
    filter.
        (c) Required test equipment. (1) Flow rate measurement device, 
    range 70 mL/min to 130 mL/min, 2 percent certified accuracy, NIST-
    traceable.
        (2) Flow rate measurement adaptor (40 CFR part 50, Appendix L, 
    Figure L-30) or equivalent adaptor to facilitate measurement of sampler 
    flow rate at the top of the downtube.
        (3) Impermeable membrane or disk, 47 mm nominal diameter.
        (4) Means, such as a micro-valve, of providing a simulated leak 
    flow rate through the sampler of approximately 80 mL/min under the 
    conditions specified for the leak check in the sampler's leak check 
    procedure.
        (5) Teflon sample filter, as specified in section 6 of 40 CFR part 
    50, Appendix L.
        (d) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and one or more non-zero flow rates within 7 days of 
    use for this test.
        (e) Test setup. (1) The test sampler shall be set up for testing as 
    described in the sampler's operation or instruction manual referred to 
    in Sec. 53.4(b)(3). The sampler shall be installed upright and set up 
    in its normal configuration for collecting PM2.5 samples, 
    except that the sample air inlet shall be removed and the flow rate 
    measurement adaptor shall be installed on the sampler's downtube.
        (2) The flow rate control device shall be set up to provide a 
    constant, controlled flow rate of 80 mL/min into the sampler downtube 
    under the conditions specified for the leak check in the sampler's leak 
    check procedure.
        (3) The flow rate measurement device shall be set up to measure the 
    controlled flow rate of 80 mL/min into the sampler downtube under the 
    conditions specified for the leak check in the sampler's leak check 
    procedure.
        (f) Procedure. (1) Install the impermeable membrane in a filter 
    cassette and install the cassette into the sampler. Carry out the 
    internal leak check procedure as described in the sampler's operation/
    instruction manual and verify that the leak check acceptance criterion 
    specified in Table E-1 of this subpart is met.
        (2) Replace the impermeable membrane with a Teflon filter and 
    install the cassette in the sampler. Remove the inlet from the sampler 
    and install the flow measurement adaptor on the sampler's downtube. 
    Close the valve of the adaptor to seal the flow system. Conduct the 
    external leak check procedure as described in the sampler's operation/
    instruction manual and verify that the leak check acceptance criteria 
    specified in Table E-1 of this subpart are met.
        (3) Arrange the flow control device, flow rate measurement device, 
    and other apparatus as necessary to provide a simulated leak flow rate 
    of 80 mL/min into the test sampler through the downtube during the 
    specified external leak check procedure. Carry out the external leak 
    check procedure as described in the sampler's operation/instruction 
    manual but with the simulated leak of 80 mL/min.
        (g) Test results. The requirements for successful passage of this 
    test are:
        (1) That the leak check procedure indicates no significant external 
    or internal leaks in the test sampler when no simulated leaks are 
    introduced.
        (2) That the leak check procedure properly identifies the 
    occurrence of the simulated external leak of 80 mL/min.
    
    
    Sec. 53.53   Test for flow rate accuracy, regulation, measurement 
    accuracy, and cut-off.
    
        (a) Overview. This test procedure is designed to evaluate a 
    candidate sampler's flow rate accuracy with respect to the design flow 
    rate, flow rate regulation, flow rate measurement accuracy, coefficient 
    of variability measurement accuracy, and the flow rate cut-off 
    function. The tests for the first four parameters shall be conducted 
    over a 6-hour time period during which reference flow measurements are 
    made at intervals not to exceed 5 minutes. The flow rate cut-off test, 
    conducted separately, is intended to verify that the sampler carries 
    out the required automatic sample flow rate cut-off function properly 
    in the event of a low-flow condition. The test conditions and 
    performance specifications associated with this test are summarized in 
    Table E-1 of this subpart. The candidate test sampler must meet all 
    test parameters and test specifications to successfully pass this test.
        (b) Technical definitions. (1) Sample flow rate means the 
    quantitative volumetric flow rate of the air stream caused by the 
    sampler to enter the sampler inlet and pass through the sample filter, 
    measured in actual volume units at the temperature and pressure of the 
    air as it enters the inlet.
        (2) The flow rate cut-off function requires the sampler to 
    automatically stop sample flow and terminate the current sample 
    collection if the sample flow rate deviates by more than the variation 
    limits specified in Table E-1 of this subpart (10 percent 
    from the nominal sample flow rate) for more than 60 seconds during a 
    sample collection period. The sampler is also required to properly 
    notify the operator with a flag warning indication of the out-of-
    specification flow rate condition and if the flow rate cut-off results 
    in an elapsed sample collection time of less than 23 hours.
        (c) Required test equipment. (1) Flow rate meter, suitable for 
    measuring and recording the actual volumetric sample flow rate at the 
    sampler downtube, with
    
    [[Page 38802]]
    
    a minimum range of 10 to 25 L/min, 2 percent certified, NIST-traceable 
    accuracy. Optional capability for continuous (analog) recording 
    capability or digital recording at intervals not to exceed 30 seconds 
    is recommended. While a flow meter which provides a direct indication 
    of volumetric flow rate is preferred for this test, an alternative 
    certified flow measurement device may be used as long as appropriate 
    volumetric flow rate corrections are made based on measurements of 
    actual ambient temperature and pressure conditions.
        (2) Ambient air temperature sensor, with a resolution of 0.1  deg.C 
    and certified to be accurate to within 0.5  deg.C (if needed). If the 
    certified flow meter does not provide direct volumetric flow rate 
    readings, ambient air temperature measurements must be made using 
    continuous (analog) recording capability or digital recording at 
    intervals not to exceed 5 minutes.
        (3) Barometer, range 600 mm Hg to 800 mm Hg, certified accurate to 
    2 mm Hg (if needed). If the certified flow meter does not provide 
    direct volumetric flow rate readings, ambient pressure measurements 
    must be made using continuous (analog) recording capability or digital 
    recording at intervals not to exceed 5 minutes.
        (4) Flow measurement adaptor (40 CFR part 50, Appendix L, Figure L-
    30) or equivalent adaptor to facilitate measurement of sample flow rate 
    at the sampler downtube.
        (5) Valve or other means to restrict or reduce the sample flow rate 
    to a value at least 10 percent below the design flow rate (16.67 L/
    min). If appropriate, the valve of the flow measurement adaptor may be 
    used for this purpose.
        (6) Means for creating an additional pressure drop of 55 mm Hg in 
    the sampler to simulate a heavily loaded filter, such as an orifice or 
    flow restrictive plate installed in the filter holder or a valve or 
    other flow restrictor temporarily installed in the flow path near the 
    filter.
        (7) Teflon sample filter, as specified in section 6 of 40 CFR part 
    50, Appendix L (if required).
        (d) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow-rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and at least one flow rate within 3 percent 
    of 16.7 L/min within 7 days prior to use for this test. Where an 
    instrument's measurements are to be recorded with an analog recording 
    device, the accuracy of the entire instrument-recorder system shall be 
    calibrated or verified.
        (e) Test setup. (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 Sec. 53.4(b)(3). The 
    sampler shall be installed upright and set up in its normal 
    configuration for collecting PM2.5 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.
        (2) The inlet of the candidate sampler shall be removed and the 
    flow measurement adaptor installed on the sampler's downtube. A leak 
    check as described in the sampler's operation or instruction manual 
    shall be conducted and must be properly passed before other tests are 
    carried out.
        (3) The inlet of the flow measurement adaptor shall be connected to 
    the outlet of the flow rate meter.
        (4) For the flow rate cut-off test, the valve or means for reducing 
    sampler flow rate shall be installed between the flow measurement 
    adaptor and the downtube or in another location within the sampler such 
    that the sampler flow rate can be manually restricted during the test.
        (f) Procedure. (1) Set up the sampler as specified in paragraph (e) 
    of this section and otherwise prepare the sampler for normal sample 
    collection operation as directed in the sampler's operation or 
    instruction manual. Set the sampler to automatically start a 6-hour 
    sample collection period at a convenient time.
        (2) During the 6-hour operational flow rate portion of the test, 
    measure and record the sample flow rate with the flow rate meter at 
    intervals not to exceed 5 minutes. If ambient temperature and pressure 
    corrections are necessary to calculate volumetric flow rate, ambient 
    temperature and pressure shall be measured at the same frequency as 
    that of the certified flow rate measurements. Note and record the 
    actual start and stop times for the 6-hour flow rate test period.
        (3) Following completion of the 6-hour flow rate test period, 
    install the flow rate reduction device and change the sampler flow rate 
    recording frequency to intervals of not more than 30 seconds. Reset the 
    sampler to start a new sample collection period. Manually restrict the 
    sampler flow rate such that the sampler flow rate is decreased slowly 
    over several minutes to a flow rate slightly less than the flow rate 
    cut-off value (15.0 L/min). Maintain this flow rate for at least 2.0 
    minutes or until the sampler stops the sample flow automatically. 
    Manually terminate the sample period, if the sampler has not terminated 
    it automatically.
        (g) Test results. At the completion of the test, validate the test 
    conditions and determine the test results as follows:
        (1) Mean sample flow rate. (i) From the certified measurements 
    (Qref) of the test sampler flow rate obtained by use of the 
    flow rate meter, tabulate each flow rate measurement in units of L/min. 
    If ambient temperature and pressure corrections are necessary to 
    calculate volumetric flow rate, each measured flow rate shall be 
    corrected using its corresponding temperature and pressure measurement 
    values. Calculate the mean flow rate for the sample period 
    (Qref,ave) as follows:
    
    Equation 1
    [GRAPHIC] [TIFF OMITTED] TR18JY97.063
    
    where:
    n equals the number of discrete certified flow rate measurements 
    over the 6-hour test period.
    
        (ii)(A) Calculate the percent difference between this mean flow 
    rate value and the design value of 16.67 L/min, as follows:
    
    Equation 2
    [GRAPHIC] [TIFF OMITTED] TR18JY97.064
    
        (B) To successfully pass the mean flow rate test, the percent 
    difference calculated in Equation 2 of this paragraph (g)(1)(ii) must 
    be within 5 percent.
        (2) Sample flow rate regulation. (i) From the certified 
    measurements of the test sampler flow rate, calculate the sample 
    coefficient of variation (CV) of the discrete measurements as follows:
    
    Equation 3
    [GRAPHIC] [TIFF OMITTED] TR18JY97.065
    
        (ii) To successfully pass the flow rate regulation test, the 
    calculated coefficient of variation for the certified flow rates must 
    not exceed 2 percent.
    
    [[Page 38803]]
    
        (3) Flow rate measurement accuracy. (i) Using the mean volumetric 
    flow rate reported by the candidate test sampler at the completion of 
    the 6-hour test period (Qind,ave), determine the accuracy of 
    the reported mean flow rate as:
    
    Equation 4
    [GRAPHIC] [TIFF OMITTED] TR18JY97.066
    
        (ii) To successfully pass the flow rate measurement accuracy test, 
    the percent difference calculated in Equation 4 of this paragraph 
    (g)(3) shall not exceed 2 percent.
        (4) Flow rate coefficient of variation measurement accuracy. (i) 
    Using the flow rate coefficient of variation indicated by the candidate 
    test sampler at the completion of the 6-hour test (%CVind), 
    determine the accuracy of this reported coefficient of variation as:
    
    Equation 5
    [GRAPHIC] [TIFF OMITTED] TR18JY97.067
    
        (ii) To successfully pass the flow rate CV measurement accuracy 
    test, the absolute difference in values calculated in Equation 5 of 
    this paragraph (g)(4) must not exceed 0.3 (CV%).
        (5) Flow rate cut-off. (i) Inspect the measurements of the sample 
    flow rate during the flow rate cut-off test and determine the time at 
    which the sample flow rate decreased to a value less than the cut-off 
    value specified in Table E-1 of this subpart. To pass this test, the 
    sampler must have automatically stopped the sample flow at least 30 
    seconds but not more than 90 seconds after the time at which the 
    sampler flow rate was determined to have decreased to a value less than 
    the cut-off value.
        (ii) At the completion of the flow rate cut-off test, download the 
    archived data from the test sampler and verify that the sampler's 
    required Flow-out-of-spec and Incorrect sample period flag indicators 
    are properly set.
    
    
    Sec. 53.54   Test for proper sampler operation following power 
    interruptions.
    
        (a) Overview. (1) This test procedure is designed to test certain 
    performance parameters of the candidate sampler during a test period in 
    which power interruptions of various duration occur. The performance 
    parameters tested are:
        (i) Proper flow rate performance of the sampler.
        (ii) Accuracy of the sampler's average flow rate, CV, and sample 
    volume measurements.
        (iii) Accuracy of the sampler's reported elapsed sampling time.
        (iv) Accuracy of the reported time and duration of power 
    interruptions.
        (2) This test shall be conducted during operation of the test 
    sampler over a continuous 6-hour test period during which the sampler's 
    flow rate shall be measured and recorded at intervals not to exceed 5 
    minutes. The performance parameters tested under this procedure, the 
    corresponding minimum performance specifications, and the applicable 
    test conditions are summarized in Table E-1 of this subpart. Each 
    performance parameter tested, as described or determined in the test 
    procedure, must meet or exceed the associated performance specification 
    to successfully pass this test.
        (b) Required test equipment. (1) Flow rate meter, suitable for 
    measuring and recording the actual volumetric sample flow rate at the 
    sampler downtube, with a minimum range of 10 to 25 L/min, 2 percent 
    certified, NIST-traceable accuracy. Optional capability for continuous 
    (analog) recording capability or digital recording at intervals not to 
    exceed 5 minutes is recommended. While a flow meter which provides a 
    direct indication of volumetric flow rate is preferred for this test, 
    an alternative certified flow measurement device may be used as long as 
    appropriate volumetric flow rate corrections are made based on 
    measurements of actual ambient temperature and pressure conditions.
        (2) Ambient air temperature sensor (if needed for volumetric 
    corrections to flow rate measurements), with a resolution of 0.1 
    deg.C, certified accurate to within 0.5  deg.C, and continuous (analog) 
    recording capability or digital recording at intervals not to exceed 5 
    minutes.
        (3) Barometer (if needed for volumetric corrections to flow rate 
    measurements), range 600 mm Hg to 800 mm Hg, certified accurate to 2 mm 
    Hg, with continuous (analog) recording capability or digital recording 
    at intervals not to exceed 5 minutes.
        (4) Flow measurement adaptor (40 CFR part 50, Appendix L, Figure L-
    30) or equivalent adaptor to facilitate measurement of sample flow rate 
    at the sampler downtube.
        (5) Means for creating an additional pressure drop of 55 mm Hg in 
    the sampler to simulate a heavily loaded filter, such as an orifice or 
    flow restrictive plate installed in the filter holder or a valve or 
    other flow restrictor temporarily installed in the flow path near the 
    filter.
        (6) Teflon sample filter, as specified in section 6 of 40 CFR part 
    50, Appendix L (if required).
        (7) Time measurement system, accurate to within 10 seconds per day.
        (c) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and at least one flow rate within 3 percent 
    of 16.7 L/min within 7 days prior to use for this test. Where an 
    instrument's measurements are to be recorded with an analog recording 
    device, the accuracy of the entire instrument-recorder system shall be 
    calibrated or verified.
        (d) Test setup. (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 
    Sec. 53.4(b)(3). The sampler shall be installed upright and set up in 
    its normal configuration for collecting PM2.5 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.
        (2) The inlet of the candidate sampler shall be removed and the 
    flow measurement adaptor installed on the sample downtube. A leak check 
    as described in the sampler's operation or instruction manual shall be 
    conducted and must be properly passed before other tests are carried 
    out.
        (3) The inlet of the flow measurement adaptor shall be connected to 
    the outlet of the flow rate meter.
        (e) Procedure. (1) Set up the sampler as specified in paragraph (d) 
    of this section and otherwise prepare the sampler for normal sample 
    collection operation as directed in the sampler's operation or 
    instruction manual. Set the sampler to automatically start a 6-hour 
    sample collection period at a convenient time.
        (2) During the entire 6-hour operational flow rate portion of the 
    test, measure and record the sample flow rate with the flow rate meter 
    at intervals not to exceed 5 minutes. If ambient temperature and 
    pressure corrections are necessary to calculate volumetric flow rate, 
    ambient temperature and pressure shall be measured at the same 
    frequency as that of the certified flow rate measurements. Note and 
    record the actual start and stop times for the 6-hour flow rate test 
    period.
        (3) During the 6-hour test period, interrupt the AC line electrical 
    power to
    
    [[Page 38804]]
    
    the sampler 5 times, with durations of 20 seconds, 40 seconds, 2 
    minutes, 7 minutes, and 20 minutes (respectively), with not less than 
    10 minutes of normal electrical power supplied between each power 
    interruption. Record the hour and minute and duration of each power 
    interruption.
        (4) At the end of the test, terminate the sample period (if not 
    automatically terminated by the sampler) and download all archived 
    instrument data from the test sampler.
        (f) Test results. At the completion of the sampling period, 
    validate the test conditions and determine the test results as follows:
        (1) Mean sample flow rate. (i) From the certified measurements 
    (Qref) of the test sampler flow rate, tabulate each flow 
    rate measurement in units of L/min. If ambient temperature and pressure 
    corrections are necessary to calculate volumetric flow rate, each 
    measured flow rate shall be corrected using its corresponding 
    temperature and pressure measurement values. Calculate the mean flow 
    rate for the sample period (Qref,ave) as follows:
    
    Equation 6
    [GRAPHIC] [TIFF OMITTED] TR18JY97.068
    
    where:
    n equals the number of discrete certified flow rate measurements 
    over the 6-hour test period, excluding flow rate values obtained 
    during periods of power interruption.
    
        (ii)(A) Calculate the percent difference between this mean flow 
    rate value and the design value of 16.67 L/min, as follows:
    
    Equation 7
    [GRAPHIC] [TIFF OMITTED] TR18JY97.069
    
        (B) To successfully pass this test, the percent difference 
    calculated in Equation 7 of this paragraph (f)(1)(ii) must be within 
    5 percent.
        (2) Sample flow rate regulation. (i) From the certified 
    measurements of the test sampler flow rate, calculate the sample 
    coefficient of variation of the discrete measurements as follows:
    
    Equation 8
    [GRAPHIC] [TIFF OMITTED] TR18JY97.070
    
        (ii) To successfully pass this test, the calculated coefficient of 
    variation for the certified flow rates must not exceed 2 percent.
        (3) Flow rate measurement accuracy. (i) Using the mean volumetric 
    flow rate reported by the candidate test sampler at the completion of 
    the 6-hour test (Qind,ave), determine the accuracy of the 
    reported mean flow rate as:
    
    Equation 9
    [GRAPHIC] [TIFF OMITTED] TR18JY97.071
    
        (ii) To successfully pass this test, the percent difference 
    calculated in Equation 9 of this paragraph (f)(3) shall not exceed 2 
    percent.
        (4) Flow rate CV measurement accuracy. (i) Using the flow rate 
    coefficient of variation indicated by the candidate test sampler at the 
    completion of the 6-hour test (%CVind), determine the 
    accuracy of the reported coefficient of variation as:
    
    Equation 10
    [GRAPHIC] [TIFF OMITTED] TR18JY97.072
    
        (ii) To successfully pass this test, the absolute difference in 
    values calculated in Equation 10 of this paragraph (f)(4) must not 
    exceed 0.3 (CV%).
        (5) Verify that the sampler properly provided a record and visual 
    display of the correct year, month, day-of-month, hour, and minute with 
    an accuracy of  2 minutes, of the start of each power 
    interruption of duration greater than 60 seconds.
        (6) Calculate the actual elapsed sample time, excluding the periods 
    of electrical power interruption. Verify that the elapsed sample time 
    reported by the sampler is accurate to within  20 seconds 
    for the 6-hour test run.
        (7) Calculate the sample volume as Qref,ave the sample 
    time, excluding periods of power interruption. Verify that the sample 
    volume reported by the sampler is within 2 percent of the calculated 
    sample volume to successfully pass this test.
        (8) Inspect the downloaded instrument data from the test sampler 
    and verify that all data are consistent with normal operation of the 
    sampler.
    
    
    Sec. 53.55   Test for effect of variations in power line voltage and 
    ambient temperature.
    
        (a) Overview. (1) This test procedure is a combined procedure to 
    test various performance parameters under variations in power line 
    voltage and ambient temperature. Tests shall be conducted in a 
    temperature controlled environment over four 6-hour time periods during 
    which reference temperature and flow rate measurements shall be made at 
    intervals not to exceed 5 minutes. Specific parameters to be evaluated 
    at line voltages of 105 and 125 volts and temperatures of -20  deg.C 
    and +40  deg.C are as follows:
        (i) Sample flow rate.
        (ii) Flow rate regulation.
        (iii) Flow rate measurement accuracy.
        (iv) Coefficient of variability measurement accuracy.
        (v) Ambient air temperature measurement accuracy.
        (vi) Proper operation of the sampler when exposed to power line 
    voltage and ambient temperature extremes.
        (2) The performance parameters tested under this procedure, the 
    corresponding minimum performance specifications, and the applicable 
    test conditions are summarized in Table E-1 of this subpart. Each 
    performance parameter tested, as described or determined in the test 
    procedure, must meet or exceed the associated performance specification 
    given. The candidate sampler must meet all specifications for the 
    associated PM2.5 method to pass this test procedure.
        (b) Technical definition. Sample flow rate means the quantitative 
    volumetric flow rate of the air stream caused by the sampler to enter 
    the sampler inlet and pass through the sample filter, measured in 
    actual volume units at the temperature and pressure of the air as it 
    enters the inlet.
        (c) Required test equipment. (1) Environmental chamber or other 
    temperature-controlled environment or environments, capable of 
    obtaining and maintaining temperatures at -20  deg.C and +40  deg.C as 
    required for the test with an accuracy of 2  deg.C. The 
    test environment(s) must be capable of maintaining these temperatures 
    within the specified limits continuously with the additional heat load 
    of the operating test sampler in the environment. Henceforth, where the 
    test procedures specify a test or environmental ``chamber,'' an 
    alternative temperature-controlled environmental area or areas may be 
    substituted, provided the required test temperatures and all other test 
    requirements are met.
        (2) Variable voltage AC power transformer, range 100 Vac to 130 
    Vac, with sufficient current capacity to operate the test sampler 
    continuously under the test conditions.
        (3) Flow rate meter, suitable for measuring and recording the 
    actual volumetric sample flow rate at the sampler downtube, with a 
    minimum range of 10 to 25 actual L/min, 2 percent certified, NIST-
    traceable accuracy. Optional capability for continuous (analog) 
    recording capability or digital recording at intervals not to exceed 5 
    minutes is recommended. While a flow
    
    [[Page 38805]]
    
    meter which provides a direct indication of volumetric flow rate is 
    preferred for this test, an alternative certified flow measurement 
    device may be used as long as appropriate volumetric flow rate 
    corrections are made based on measurements of actual ambient 
    temperature and pressure conditions.
        (4) Ambient air temperature recorder, range -30  deg.C to +50 
    deg.C, with a resolution of 0.1  deg.C and certified accurate to within 
    0.5  deg.C. Ambient air temperature measurements must be made using 
    continuous (analog) recording capability or digital recording at 
    intervals not to exceed 5 minutes.
        (5) Barometer, range 600 mm Hg to 800 mm Hg, certified accurate to 
    2 mm Hg. If the certified flow rate meter does not provide direct 
    volumetric flow rate readings, ambient pressure measurements must be 
    made using continuous (analog) recording capability or digital 
    recording at intervals not to exceed 5 minutes.
        (6) Flow measurement adaptor (40 CFR part 50, Appendix L, Figure L-
    30) or equivalent adaptor to facilitate measurement of sampler flow 
    rate at the sampler downtube.
        (7) Means for creating an additional pressure drop of 55 mm Hg in 
    the sampler to simulate a heavily loaded filter, such as an orifice or 
    flow restrictive plate installed in the filter holder or a valve or 
    other flow restrictor temporarily installed in the flow path near the 
    filter.
        (8) AC RMS voltmeter, accurate to 1.0 volt.
        (9) Teflon sample filter, as specified in section 6 of 40 CFR part 
    50, Appendix L (if required).
        (d) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and at least one flow rate within 3 percent 
    of 16.7 L/min within 7 days prior to use for this test. Where an 
    instrument's measurements are to be recorded with an analog recording 
    device, the accuracy of the entire instrument-recorder system shall be 
    calibrated or verified.
        (e) Test setup. (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 
    Sec. 53.4(b)(3). The sampler shall be installed upright and set up in 
    the temperature-controlled chamber in its normal configuration for 
    collecting PM2.5 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.
        (2) The inlet of the candidate sampler shall be removed and the 
    flow measurement adaptor installed on the sampler's downtube. A leak 
    check as described in the sampler's operation or instruction manual 
    shall be conducted and must be properly passed before other tests are 
    carried out.
        (3) The inlet of the flow measurement adaptor shall be connected to 
    the outlet of the flow rate meter.
        (4) The ambient air temperature recorder shall be installed in the 
    test chamber such that it will accurately measure the temperature of 
    the air in the vicinity of the candidate sampler without being unduly 
    affected by the chamber's air temperature control system.
        (f) Procedure. (1) Set up the sampler as specified in paragraph (e) 
    of this section and otherwise prepare the sampler for normal sample 
    collection operation as directed in the sampler's operation or 
    instruction manual.
        (2) The test shall consist of four test runs, one at each of the 
    following conditions of chamber temperature and electrical power line 
    voltage (respectively):
        (i) -20  deg.C 2  deg.C and 105 1 Vac.
        (ii) -20  deg.C 2  deg.C and 125 1 Vac.
        (iii) +40  deg.C 2  deg.C and 105 1 Vac.
        (iv) +40  deg.C 2  deg.C and 125 1 Vac.
        (3) For each of the four test runs, set the selected chamber 
    temperature and power line voltage for the test run. Upon achieving 
    each temperature setpoint in the chamber, the candidate sampler and 
    flow meter shall be thermally equilibrated for a period of at least 2 
    hours prior to the test run. Following the thermal conditioning time, 
    set the sampler to automatically start a 6-hour sample collection 
    period at a convenient time.
        (4) During each 6-hour test period:
        (i) Measure and record the sample flow rate with the flow rate 
    meter at intervals not to exceed 5 minutes. If ambient temperature and 
    pressure corrections are necessary to calculate volumetric flow rate, 
    ambient temperature and pressure shall be measured at the same 
    frequency as that of the certified flow rate measurements. Note and 
    record the actual start and stop times for the 6-hour flow rate test 
    period.
        (ii) Determine and record the ambient (chamber) temperature 
    indicated by the sampler and the corresponding ambient (chamber) 
    temperature measured by the ambient temperature recorder specified in 
    paragraph (c)(4) of this section at intervals not to exceed 5 minutes.
        (iii) Measure the power line voltage to the sampler at intervals 
    not greater than 1 hour.
        (5) At the end of each test run, terminate the sample period (if 
    not automatically terminated by the sampler) and download all archived 
    instrument data from the test sampler.
        (g) Test results. For each of the four test runs, examine the 
    chamber temperature measurements and the power line voltage 
    measurements. Verify that the temperature and line voltage met the 
    requirements specified in paragraph (f) of this section at all times 
    during the test run. If not, the test run is not valid and must be 
    repeated. Determine the test results as follows:
        (1) Mean sample flow rate. (i) From the certified measurements 
    (Qref) of the test sampler flow rate, tabulate each flow 
    rate measurement in units of L/min. If ambient temperature and pressure 
    corrections are necessary to calculate volumetric flow rate, each 
    measured flow rate shall be corrected using its corresponding 
    temperature and pressure measurement values. Calculate the mean flow 
    rate for each sample period (Qref,ave) as follows:
    
    Equation 11
    [GRAPHIC] [TIFF OMITTED] TR18JY97.073
    
    where:
    n equals the number of discrete certified flow rate measurements 
    over each 6-hour test period.
    
        (ii)(A) Calculate the percent difference between this mean flow 
    rate value and the design value of 16.67 L/min, as follows:
    
    Equation 12
    [GRAPHIC] [TIFF OMITTED] TR18JY97.074
    
        (B) To successfully pass this test, the percent difference 
    calculated in Equation 12 of this paragraph (g)(1)(ii) must be within 
    5 percent for each test run.
        (2) Sample flow rate regulation. (i) From the certified 
    measurements of the test sampler flow rate, calculate the sample 
    coefficient of variation of the discrete measurements as follows:
    
    [[Page 38806]]
    
    Equation 13
    [GRAPHIC] [TIFF OMITTED] TR18JY97.075
    
        (ii) To successfully pass this test, the calculated coefficient of 
    variation for the certified flow rates must not exceed 2 percent.
        (3) Flow rate measurement accuracy. (i) Using the mean volumetric 
    flow rate reported by the candidate test sampler at the completion of 
    each 6-hour test (Qind,ave), determine the accuracy of the 
    reported mean flow rate as:
    
    Equation 14
    [GRAPHIC] [TIFF OMITTED] TR18JY97.076
    
        (ii) To successfully pass this test, the percent difference 
    calculated in Equation 14 of this paragraph (g)(3) shall not exceed 2 
    percent for each test run.
        (4) Flow rate coefficient of variation measurement accuracy. (i) 
    Using the flow rate coefficient of variation indicated by the candidate 
    test sampler (%CVind), determine the accuracy of the 
    reported coefficient of variation as:
    
    Equation 15
    [GRAPHIC] [TIFF OMITTED] TR18JY97.077
    
        (ii) To successfully pass this test, the absolute difference 
    calculated in Equation 15 of this paragraph (g)(4) must not exceed 0.3 
    (CV%) for each test run.
        (5) Ambient temperature measurement accuracy. (i) Calculate the 
    absolute value of the difference between the mean ambient air 
    temperature indicated by the test sampler and the mean ambient 
    (chamber) air temperature measured with the ambient air temperature 
    recorder as:
    
    Equation 16
    [GRAPHIC] [TIFF OMITTED] TR18JY97.078
    
    where:
    Tind,ave = mean ambient air temperature indicated by the 
    test sampler,  deg.C; and
    Tref,ave = mean ambient air temperature measured by the 
    reference temperature instrument,  deg.C.
    
        (ii) The calculated temperature difference must be less than 2 
    deg.C for each test run.
        (6) Sampler functionality. To pass the sampler functionality test, 
    the following two conditions must both be met for each test run:
        (i) The sampler must not shutdown during any portion of the 6-hour 
    test.
        (ii) An inspection of the downloaded data from the test sampler 
    verifies that all the data are consistent with normal operation of the 
    sampler.
    
    
    Sec. 53.56   Test for effect of variations in ambient pressure.
    
        (a) Overview. (1) This test procedure is designed to test various 
    sampler performance parameters under variations in ambient (barometric) 
    pressure. Tests shall be conducted in a pressure-controlled environment 
    over two 6-hour time periods during which reference pressure and flow 
    rate measurements shall be made at intervals not to exceed 5 minutes. 
    Specific parameters to be evaluated at operating pressures of 600 and 
    800 mm Hg are as follows:
        (i) Sample flow rate.
        (ii) Flow rate regulation.
        (iii) Flow rate measurement accuracy.
        (iv) Coefficient of variability measurement accuracy.
        (v) Ambient pressure measurement accuracy.
        (vi) Proper operation of the sampler when exposed to ambient 
    pressure extremes.
        (2) The performance parameters tested under this procedure, the 
    corresponding minimum performance specifications, and the applicable 
    test conditions are summarized in Table E-1 of this subpart. Each 
    performance parameter tested, as described or determined in the test 
    procedure, must meet or exceed the associated performance specification 
    given. The candidate sampler must meet all specifications for the 
    associated PM2.5 method to pass this test procedure.
        (b) Technical definition. Sample flow rate means the quantitative 
    volumetric flow rate of the air stream caused by the sampler to enter 
    the sampler inlet and pass through the sample filter, measured in 
    actual volume units at the temperature and pressure of the air as it 
    enters the inlet.
        (c) Required test equipment. (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 Sec. 53.4(a) prior to conducting the test for a specific individual 
    determination of acceptability.
        (2) Flow rate meter, suitable for measuring and recording the 
    actual volumetric sampler flow rate at the sampler downtube, with a 
    minimum range of 10 to 25 L/min, 2 percent certified, NIST-traceable 
    accuracy. Optional capability for continuous (analog) recording 
    capability or digital recording at intervals not to exceed 5 minutes is 
    recommended. While a flow meter which provides a direct indication of 
    volumetric flow rate is preferred for this test, an alternative 
    certified flow measurement device may be used as long as appropriate 
    volumetric flow rate corrections are made based on measurements of 
    actual ambient temperature and pressure conditions.
        (3) Ambient air temperature recorder (if needed for volumetric 
    corrections to flow rate measurements) with a range -30  deg.C to +50 
    deg.C, certified accurate to within 0.5  deg.C. If the certified flow 
    meter does not provide direct volumetric flow rate readings, ambient 
    temperature measurements must be made using continuous (analog) 
    recording capability or digital recording at intervals not to exceed 5 
    minutes.
        (4) Barometer, range 600 mm Hg to 800 mm Hg, certified accurate to 
    2 mm Hg. Ambient air pressure measurements must be made using 
    continuous (analog) recording capability or digital recording at 
    intervals not to exceed 5 minutes.
        (5) Flow measurement adaptor (40 CFR part 50, Appendix L, Figure L-
    30) or equivalent adaptor to facilitate measurement of sampler flow 
    rate at the sampler downtube.
        (6) Means for creating an additional pressure drop of 55 mm Hg in 
    the sampler to simulate a heavily loaded filter, such as an orifice or 
    flow restrictive plate installed in the filter holder or a valve or 
    other flow restrictor temporarily installed in the flow path near the 
    filter.
        (7) Teflon sample filter, as specified in section 6 of 40 CFR part 
    50, Appendix L (if required).
        (d) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and at least one flow rate within 3 percent 
    of 16.7 L/min within 7 days prior to use for this test. Where an 
    instrument's measurements are to be
    
    [[Page 38807]]
    
    recorded with an analog recording device, the accuracy of the entire 
    instrument-recorder system shall be calibrated or verified.
        (e) Test setup. (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 
    Sec. 53.4(b)(3). The sampler shall be installed upright and set up in 
    the pressure-controlled chamber in its normal configuration for 
    collecting PM2.5 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.
        (2) The inlet of the candidate sampler shall be removed and the 
    flow measurement adaptor installed on the sampler's downtube. A leak 
    check as described in the sampler's operation or instruction manual 
    shall be conducted and must be properly passed before other tests are 
    carried out.
        (3) The inlet of the flow measurement adaptor shall be connected to 
    the outlet of the flow rate meter.
        (4) The barometer shall be installed in the test chamber such that 
    it will accurately measure the air pressure to which the candidate 
    sampler is subjected.
        (f) Procedure. (1) Set up the sampler as specified in paragraph (e) 
    of this section and otherwise prepare the sampler for normal sample 
    collection operation as directed in the sampler's operation or 
    instruction manual.
        (2) The test shall consist of two test runs, one at each of the 
    following conditions of chamber pressure:
        (i) 600 mm Hg.
        (ii) 800 mm Hg.
        (3) For each of the two test runs, set the selected chamber 
    pressure for the test run. Upon achieving each pressure setpoint in the 
    chamber, the candidate sampler shall be pressure-equilibrated for a 
    period of at least 30 minutes prior to the test run. Following the 
    conditioning time, set the sampler to automatically start a 6-hour 
    sample collection period at a convenient time.
        (4) During each 6-hour test period:
        (i) Measure and record the sample flow rate with the flow rate 
    meter at intervals not to exceed 5 minutes. If ambient temperature and 
    pressure corrections are necessary to calculate volumetric flow rate, 
    ambient temperature and pressure shall be measured at the same 
    frequency as that of the certified flow rate measurements. Note and 
    record the actual start and stop times for the 6-hour flow rate test 
    period.
        (ii) Determine and record the ambient (chamber) pressure indicated 
    by the sampler and the corresponding ambient (chamber) pressure 
    measured by the barometer specified in paragraph (c)(4) of this section 
    at intervals not to exceed 5 minutes.
        (5) At the end of each test period, terminate the sample period (if 
    not automatically terminated by the sampler) and download all archived 
    instrument data from the test sampler.
        (g) Test results. For each of the two test runs, examine the 
    chamber pressure measurements. Verify that the pressure met the 
    requirements specified in paragraph (f) of this section at all times 
    during the test. If not, the test run is not valid and must be 
    repeated. Determine the test results as follows:
        (1) Mean sample flow rate. (i) From the certified measurements 
    (Qref) of the test sampler flow rate, tabulate each flow 
    rate measurement in units of L/min. If ambient temperature and pressure 
    corrections are necessary to calculate volumetric flow rate, each 
    measured flow rate shall be corrected using its corresponding 
    temperature and pressure measurement values. Calculate the mean flow 
    rate for the sample period (Qref,ave) as follows:
    
    Equation 17
    [GRAPHIC] [TIFF OMITTED] TR18JY97.079
    
    where:
    n equals the number of discrete certified flow measurements over the 
    6-hour test period.
    
        (ii)(A) Calculate the percent difference between this mean flow 
    rate value and the design value of 16.67 L/min, as follows:
    
    Equation 18
    [GRAPHIC] [TIFF OMITTED] TR18JY97.080
    
        (B) To successfully pass this test, the percent difference 
    calculated in Equation 18 of this paragraph (g)(1) must be within 
    5 percent for each test run.
        (2) Sample flow rate regulation. (i) From the certified 
    measurements of the test sampler flow rate, calculate the sample 
    coefficient of variation of the discrete measurements as follows:
    
    Equation 19
    [GRAPHIC] [TIFF OMITTED] TR18JY97.081
    
        (ii) To successfully pass this test, the calculated coefficient of 
    variation for the certified flow rates must not exceed 2 percent.
        (3) Flow rate measurement accuracy. (i) Using the mean volumetric 
    flow rate reported by the candidate test sampler at the completion of 
    each 6-hour test (Qind,ave), determine the accuracy of the 
    reported mean flow rate as:
    
    Equation 20
    [GRAPHIC] [TIFF OMITTED] TR18JY97.082
    
        (ii) To successfully pass this test, the percent difference 
    calculated in Equation 20 of this paragraph (g)(3) shall not exceed 2 
    percent for each test run.
        (4) Flow rate CV measurement accuracy. (i) Using the flow rate 
    coefficient of variation indicated by the candidate test sampler at the 
    completion of the 6-hour test (%CVind), determine the 
    accuracy of the reported coefficient of variation as:
    
    Equation 21
    [GRAPHIC] [TIFF OMITTED] TR18JY97.083
    
        (ii) To successfully pass this test, the absolute difference in 
    values calculated in Equation 21 of this paragraph (g)(4) must not 
    exceed 0.3 (CV%) for each test run.
        (5) Ambient pressure measurement accuracy. (i) Calculate the 
    absolute difference between the mean ambient air pressure indicated by 
    the test sampler and the ambient (chamber) air pressure measured with 
    the reference barometer as:
    
    Equation 22
    [GRAPHIC] [TIFF OMITTED] TR18JY97.084
    
    
    [[Page 38808]]
    
    
    where:
    Pind,ave = mean ambient pressure indicated by the test 
    sampler, mm Hg; and
    Pref,ave = mean barometric pressure measured by the 
    reference barometer, mm Hg.
    
        (ii) The calculated pressure difference must be less than 10 mm Hg 
    for each test run to pass the test.
        (6) Sampler functionality. To pass the sampler functionality test, 
    the following two conditions must both be met for each test run:
        (i) The sampler must not shut down during any part of the 6-hour 
    tests; and
        (ii) An inspection of the downloaded data from the test sampler 
    verifies that all the data are consistent with normal operation of the 
    sampler.
    
    
    Sec. 53.57   Test for filter temperature control during sampling and 
    post-sampling periods.
    
        (a) Overview. This test is intended to measure the candidate 
    sampler's ability to prevent excessive overheating of the 
    PM2.5 sample collection filter (or filters) under conditions 
    of elevated solar insolation. The test evaluates radiative effects on 
    filter temperature during a 4-hour period of active sampling as well as 
    during a subsequent 4-hour non-sampling time period prior to filter 
    retrieval. Tests shall be conducted in an environmental chamber which 
    provides the proper radiant wavelengths and energies to adequately 
    simulate the sun's radiant effects under clear conditions at sea level. 
    For additional guidance on conducting solar radiative tests under 
    controlled conditions, consult military standard specification 810-E 
    (Reference 6 in Appendix A of this subpart). The performance parameters 
    tested under this procedure, the corresponding minimum performance 
    specifications, and the applicable test conditions are summarized in 
    Table E-1 of this subpart. Each performance parameter tested, as 
    described or determined in the test procedure, must meet or exceed the 
    associated performance specification to successfully pass this test.
        (b) Technical definition. Filter temperature control during 
    sampling is the ability of a sampler to maintain the temperature of the 
    particulate matter sample filter within the specified deviation (5 
    deg.C) from ambient temperature during any active sampling period. 
    Post-sampling temperature control is the ability of a sampler to 
    maintain the temperature of the particulate matter sample filter within 
    the specified deviation from ambient temperature during the period from 
    the end of active sample collection of the PM2.5 sample by 
    the sampler until the filter is retrieved from the sampler for 
    laboratory analysis.
        (c) Required test equipment. (1) Environmental chamber providing 
    the means, such as a bank of solar-spectrum lamps, for generating or 
    simulating thermal radiation in approximate spectral content and 
    intensity equivalent to solar insolation of 1000  50 W/
    m2 inside the environmental chamber. To properly simulate 
    the sun's radiative effects on the sampler, the solar bank must provide 
    the spectral energy distribution and permitted tolerances specified in 
    Table E-2 of this subpart. The solar radiation source area shall be 
    such that the width of the candidate sampler shall not exceed one-half 
    the dimensions of the solar bank. The solar bank shall be located a 
    minimum of 76 cm (30 inches) from any surface of the candidate sampler. 
    To meet requirements of the solar radiation tests, the chamber's 
    internal volume shall be a minimum of 10 times that of the volume of 
    the candidate sampler. Air velocity in the region of the sampler must 
    be maintained continuously during the radiative tests at 2.0 
     0.5 m/sec.
        (2) Ambient air temperature recorder, range -30  deg.C to +50 
    deg.C, with a resolution of 0.1  deg.C and certified accurate to within 
    0.5  deg.C. Ambient air temperature measurements must be made using 
    continuous (analog) recording capability or digital recording at 
    intervals not to exceed 5 minutes.
        (3) Flow measurement adaptor (40 CFR part 50, Appendix L, Figure L-
    30) or equivalent adaptor to facilitate measurement of sampler flow 
    rate at the sampler downtube.
        (4) Miniature temperature sensor(s), capable of being installed in 
    the sampler without introducing air leakage and capable of measuring 
    the sample air temperature within 1 cm of the center of the filter, 
    downstream of the filter; with a resolution of 0.1  deg.C, certified 
    accurate to within 0.5  deg.C, NIST-traceable, with continuous (analog) 
    recording capability or digital recording at intervals of not more than 
    5 minutes.
        (5) Solar radiometer, to measure the intensity of the simulated 
    solar radiation in the test environment, range of 0 to approximately 
    1500 W/m2. Optional capability for continuous (analog) 
    recording or digital recording at intervals not to exceed 5 minutes is 
    recommended.
        (6) Sample filter or filters, as specified in section 6 of 40 CFR 
    part 50, Appendix L.
        (d) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and at least one flow rate within 3 percent 
    of 16.7 L/min within 7 days prior to use for this test. Where an 
    instrument's measurements are to be recorded with an analog recording 
    device, the accuracy of the entire instrument-recorder system shall be 
    calibrated or verified.
        (e) Test setup. (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 
    Sec. 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 PM2.5 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 5 additional filters for magazine-
    type sequential samplers) as directed by the sampler's operation or 
    instruction manual.
        (2) The miniature temperature sensor shall be temporarily installed 
    in the test sampler such that it accurately measures the air 
    temperature 1 cm from the center of the filter on the downstream side 
    of the filter. The sensor shall be installed such that no external or 
    internal air leakage is created by the sensor installation. The 
    sensor's dimensions and installation shall be selected to minimize 
    temperature measurement uncertainties due to thermal conduction along 
    the sensor mounting structure or sensor conductors. For sequential 
    samplers, similar temperature sensors shall also be temporarily 
    installed in the test sampler to monitor the temperature 1 cm from the 
    center of each filter stored in the sampler for sequential sample 
    operation.
        (3) The solar radiant energy source shall be installed in the test 
    chamber such that the entire test sampler is irradiated in a manner 
    similar to the way it would be irradiated by solar radiation if it were 
    located outdoors in an open area on a sunny day, with the radiation 
    arriving at an angle of between 30 deg. and 45 deg. from vertical. The 
    intensity of the radiation received by all sampler
    
    [[Page 38809]]
    
    surfaces that receive direct radiation shall average 1000  
    50 W/m2, measured in a plane perpendicular to the incident 
    radiation. The incident radiation shall be oriented with respect to the 
    sampler such that the area of the sampler's ambient temperature sensor 
    (or temperature shield) receives full, direct radiation as it would or 
    could during normal outdoor installation. Also, the temperature sensor 
    must not be shielded or shaded from the radiation by a sampler part in 
    a way that would not occur at other normal insolation angles or 
    directions.
        (4) The solar radiometer shall be installed in a location where it 
    measures thermal radiation that is generally representative of the 
    average thermal radiation intensity that the upper portion of the 
    sampler and sampler inlet receive. The solar radiometer shall be 
    oriented so that it measures the radiation in a plane perpendicular to 
    its angle of incidence.
        (5) The ambient air temperature recorder shall be installed in the 
    test chamber such that it will accurately measure the temperature of 
    the air in the chamber without being unduly affected by the chamber's 
    air temperature control system or by the radiant energy from the solar 
    radiation source that may be present inside the test chamber.
        (f) Procedure. (1) Set up the sampler as specified in paragraph (e) 
    of this section and otherwise prepare the sampler for normal sample 
    collection operation as directed in the sampler's operation or 
    instruction manual.
        (2) Remove the inlet of the candidate test sampler and install the 
    flow measurement adaptor on the sampler's downtube. Conduct a leak 
    check as described in the sampler's operation or instruction manual. 
    The leak test must be properly passed before other tests are carried 
    out.
        (3) Remove the flow measurement adaptor from the downtube and re-
    install the sampling inlet.
        (4) Activate the solar radiation source and verify that the 
    resulting energy distribution prescribed in Table E-2 of this subpart 
    is achieved.
        (5) Program the test sampler to conduct a single sampling run of 4 
    continuous hours. During the 4-hour sampling run, measure and record 
    the radiant flux, ambient temperature, and filter temperature (all 
    filter temperatures for sequential samplers) at intervals not to exceed 
    5 minutes.
        (6) At the completion of the 4-hour sampling phase, terminate the 
    sample period, if not terminated automatically by the sampler. Continue 
    to measure and record the radiant flux, ambient temperature, and filter 
    temperature or temperatures for 4 additional hours at intervals not to 
    exceed 5 minutes. At the completion of the 4-hour post-sampling period, 
    discontinue the measurements and turn off the solar source.
        (7) Download all archived sampler data from the test run.
        (g) Test results. Chamber temperature control. Examine the 
    continuous record of the chamber radiant flux and verify that the flux 
    met the requirements specified in Table E-2 of this subpart at all 
    times during the test. If not, the entire test is not valid and must be 
    repeated.
        (1) Filter temperature measurement accuracy. (i) For each 4-hour 
    test period, calculate the absolute value of the difference between the 
    mean filter temperature indicated by the sampler (active filter) and 
    the mean filter temperature measured by the reference temperature 
    sensor installed within 1 cm downstream of the (active) filter as:
    
    Equation 23
    [GRAPHIC] [TIFF OMITTED] TR18JY97.085
    
    where:
    Tind,filter = mean filter temperature indicated by the 
    test sampler,  deg.C; and
    Tref,filter = mean filter temperature measured by the 
    reference temperature sensor,  deg.C.
    
        (ii) To successfully pass the indicated filter temperature accuracy 
    test, the calculated difference between the measured means 
    (Tdiff,filter) must not exceed 2  deg.C for each 4-hour test 
    period.
        (2) Ambient temperature measurement accuracy. (i) For each 4-hour 
    test period, calculate the absolute value of the difference between the 
    mean ambient air temperature indicated by the test sampler and the mean 
    ambient air temperature measured by the reference ambient air 
    temperature recorder as:
    
    Equation 24
    [GRAPHIC] [TIFF OMITTED] TR18JY97.086
    
    where:
    Tind,ambient = mean ambient air temperature indicated by 
    the test sampler,  deg.C; and
    Tref,ambient = mean ambient air temperature measured by 
    the reference ambient air temperature recorder,  deg.C.
    
        (ii) To successfully pass the indicated ambient temperature 
    accuracy test, the calculated difference between the measured means 
    (Tdiff,ambient) must not exceed 2  deg.C for each 4-hour 
    test period.
        (3) Filter temperature control accuracy. (i) For each temperature 
    measurement interval over each 4-hour test period, calculate the 
    difference between the filter temperature indicated by the reference 
    temperature sensor and the ambient temperature indicated by the test 
    sampler as:
    
    Equation 25
    [GRAPHIC] [TIFF OMITTED] TR18JY97.087
    
        (ii) Tabulate and inspect the calculated differences as a function 
    of time. To successfully pass the indicated filter temperature control 
    test, the calculated difference between the measured values must not 
    exceed 5  deg.C for any consecutive intervals covering more than a 30-
    minute time period.
        (iii) For sequential samplers, repeat the test calculations for 
    each of the stored sequential sample filters. All stored filters must 
    also meet the 5  deg.C temperature control test.
    
    
    Sec. 53.58   Operational field precision and blank test.
    
        (a) Overview. This test is intended to determine the operational 
    precision of the candidate sampler during a minimum of 10 days of field 
    operation, using three collocated test samplers. Measurements of 
    PM2.5 are made at a test site with all of the samplers and 
    then compared to determine replicate precision. Candidate sequential 
    samplers are also subject to a test for possible deposition of 
    particulate matter on inactive filters during a period of storage in 
    the sampler. This procedure is applicable to both reference and 
    equivalent methods. In the case of equivalent methods, this test may be 
    combined and conducted concurrently with the comparability test for 
    equivalent methods (described in subpart C of this part), using three 
    reference method samplers collocated with three candidate equivalent 
    method samplers and meeting the applicable site and other requirements 
    of subpart C of this part.
        (b) Technical definition. (1) Field precision is defined as the 
    standard deviation or relative standard deviation of a set of 
    PM2.5 measurements obtained concurrently with three or more 
    collocated samplers in actual ambient air field operation.
        (2) Storage deposition is defined as the mass of material 
    inadvertently deposited on a sample filter that is stored in a 
    sequential sampler either prior to or subsequent to the active sample 
    collection period.
        (c) Test site. Any outdoor test site having PM2.5 
    concentrations that are reasonably uniform over the test area and that 
    meet the minimum level requirement of paragraph (g)(2) of this section 
    is acceptable for this test.
        (d) Required facilities and equipment. (1) An appropriate test site 
    and suitable
    
    [[Page 38810]]
    
    electrical power to accommodate three test samplers are required.
        (2) Teflon sample filters, as specified in section 6 of 40 CFR part 
    50, Appendix L, conditioned and preweighed as required by section 8 of 
    40 CFR part 50, Appendix L, as needed for the test samples.
        (e) Test setup. (1) Three identical test samplers shall be 
    installed at the test site in their normal configuration for collecting 
    PM2.5 samples in accordance with the instructions in the 
    associated manual referred to in Sec. 53.4(b)(3) and should be 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 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.
        (2) Each test sampler shall be successfully leak checked, 
    calibrated, and set up for normal operation in accordance with the 
    instruction manual and with any applicable supplemental guidance 
    provided in Reference 3 in Appendix A of this subpart.
        (f) Test procedure. (1) Install a conditioned, preweighed filter in 
    each test sampler and otherwise prepare each sampler for normal sample 
    collection. Set identical sample collection start and stop times for 
    each sampler. For sequential samplers, install a conditioned, 
    preweighed specified filter in each available channel or station 
    intended for automatic sequential sample filter collection (or at least 
    5 additional filters for magazine-type sequential samplers), as 
    directed by the sampler's operation or instruction manual. Since the 
    inactive sequential channels are used for the storage deposition part 
    of the test, they may not be used to collect the active 
    PM2.5 test samples.
        (2) Collect either a 24-hour or a 48-hour atmospheric 
    PM2.5 sample simultaneously with each of the three test 
    samplers.
        (3) Following sample collection, retrieve the collected sample from 
    each sampler. For sequential samplers, retrieve the additional stored 
    (blank, unsampled) filters after at least 5 days (120 hours) storage in 
    the sampler if the active samples are 24-hour samples, or after at 
    least 10 days (240 hours) if the active samples are 48-hour samples.
        (4) Determine the measured PM2.5 mass concentration for 
    each sample in accordance with the applicable procedures prescribed for 
    the candidate method in Appendix L, 40 CFR part 50 of this chapter, in 
    the associated manual referred to in Sec. 53.4(b)(3) and in accordance 
    with supplemental guidance in Reference 2 in Appendix A of this 
    subpart. For sequential samplers, also similarly determine the storage 
    deposition as the net weight gain of each blank, unsampled filter after 
    the 5-day (or 10-day) period of storage in the sampler.
        (5) Repeat this procedure to obtain a total of 10 sets of any 
    combination of 24-hour or 48-hour PM2.5 measurements over 10 
    test periods. For sequential samplers, repeat the 5-day (or 10-day) 
    storage test of additional blank filters once for a total of two sets 
    of blank filters.
        (g) Calculations. (1) Record the PM2.5 concentration for 
    each test sampler for each test period as Ci,j, where i is 
    the sampler number (i=1,2,3) and j is the test period (j=1,2, . . . 
    10).
        (2)(i) For each test period, calculate and record the average of 
    the three measured PM2.5 concentrations as Cj 
    where j is the test period:
    
    Equation 26
    [GRAPHIC] [TIFF OMITTED] TR18JY97.088
    
        (ii) If Cave,j < 10="">g/m3 for any 
    test period, data from that test period are unacceptable, and an 
    additional sample collection set must be obtained to replace the 
    unacceptable data.
        (3)(i) Calculate and record the precision for each of the 10 test 
    days as:
    
    Equation 27
    [GRAPHIC] [TIFF OMITTED] TR18JY97.089
    
        (ii) If Cave,j is below 40 g/m3 for 
    24-hour measurements or below 30 g/m3 for 48-hour 
    measurements; or
    
    Equation 28
    [GRAPHIC] [TIFF OMITTED] TR18JY97.090
    
        (iii) If Cave,j is above 40 g/m3 for 
    24-hour measurements or above 30 g/m3 for 48-hour 
    measurements.
    
        (h) Test results. (1) The candidate method passes the precision 
    test if all 10 Pj or RPj values meet the 
    specifications in Table E-1 of this subpart.
        (2) The candidate sequential sampler passes the blank filter 
    storage deposition test if the average net storage deposition weight 
    gain of each set of blank filters (total of the net weight gain of each 
    blank filter divided by the number of filters in the set) from each 
    test sampler (six sets in all) is less than 50 g.
    
    
    Sec. 53.59   Aerosol transport test for Class I equivalent method 
    samplers.
    
        (a) Overview. This test is intended to verify adequate aerosol 
    transport through any modified or air flow splitting components that 
    may be used in a Class I candidate equivalent method sampler such as 
    may be necessary to achieve sequential sampling capability. This test 
    is applicable to all Class I candidate samplers in which the aerosol 
    flow path (the flow path through which sample air passes upstream of 
    sample collection filter) differs from that specified for reference 
    method samplers as specified in 40 CFR part 50, Appendix L. The test 
    requirements and performance specifications for this test are 
    summarized in Table E-1 of this subpart.
        (b) Technical definitions. (1) Aerosol transport is the percentage 
    of a laboratory challenge aerosol which penetrates to the active sample 
    filter of the candidate equivalent method sampler.
        (2) The active sample filter is the exclusive filter through which 
    sample air is flowing during performance of this test.
        (3) A no-flow filter is a sample filter through which no sample air 
    is intended to flow during performance of this test.
        (4) A channel is any of two or more flow paths that the aerosol may 
    take, only one of which may be active at a time.
        (5) An added component is any physical part of the sampler which is 
    different in some way from that specified for a reference method 
    sampler in 40 CFR part 50, Appendix L, such as a device or means to 
    allow or cause the aerosol to be routed to one of several channels.
        (c) Required facilities and test equipment. (1) Aerosol generation 
    system, as specified in Sec. 53.62(c)(2).
        (2) Aerosol delivery system, as specified in Sec. 53.64(c)(2).
        (3) Particle size verification equipment, as specified in 
    Sec. 53.62(c)(3).
        (4) Fluorometer, as specified in Sec. 53.62(c)(7).
        (5) Candidate test sampler, with the inlet and impactor or 
    impactors removed, and with all internal surfaces of added components 
    electroless nickel coated as specified in Sec. 53.64(d)(2).
        (6) Filters that are appropriate for use with fluorometric methods 
    (e.g., glass fiber).
    
    [[Page 38811]]
    
        (d) Calibration of test measurement instruments. Submit 
    documentation showing evidence of appropriately recent calibration, 
    certification of calibration accuracy, and NIST-traceability (if 
    required) of all measurement instruments used in the tests. The 
    accuracy of flow rate meters shall be verified at the highest and 
    lowest pressures and temperatures used in the tests and shall be 
    checked at zero and at least one flow rate within 3 percent 
    of 16.7 L/min within 7 days prior to use for this test. Where an 
    instrument's measurements are to be recorded with an analog recording 
    device, the accuracy of the entire instrument-recorder system shall be 
    calibrated or verified.
        (e) Test setup. (1) The candidate test sampler shall have its inlet 
    and impactor or impactors removed. The lower end of the down tube shall 
    be reconnected to the filter holder, using an extension of the 
    downtube, if necessary. If the candidate sampler has a separate 
    impactor for each channel, then for this test, the filter holder 
    assemblies must be connected to the physical location on the sampler 
    where the impactors would normally connect.
        (2) The test particle delivery system shall be connected to the 
    sampler downtube so that the test aerosol is introduced at the top of 
    the downtube.
        (f) Test procedure. (1) All surfaces of the added or modified 
    component or components which come in contact with the aerosol flow 
    shall be thoroughly washed with 0.01 N NaOH and then dried.
        (2) Generate aerosol. (i) Generate aerosol composed of oleic acid 
    with a uranine fluorometric tag of 3  0.25 m 
    aerodynamic diameter using a vibrating orifice aerosol generator 
    according to conventions specified in Sec. 53.61(g).
        (ii) Check for the presence of satellites and adjust the generator 
    to minimize their production.
        (iii) Calculate the aerodynamic particle size using the operating 
    parameters of the vibrating orifice aerosol generator. The calculated 
    aerodynamic diameter must be 3  0.25 m aerodynamic 
    diameter.
        (3) Verify the particle size according to procedures specified in 
    Sec. 53.62(d)(4)(i).
        (4) Collect particles on filters for a time period such that the 
    relative error of the resulting measured fluorometric concentration for 
    the active filter is less than 5 percent.
        (5) Determine the quantity of material collected on the active 
    filter using a calibrated fluorometer. Record the mass of fluorometric 
    material for the active filter as Mactive (i) where i = the 
    active channel number.
        (6) Determine the quantity of material collected on each no-flow 
    filter using a calibrated fluorometer. Record the mass of fluorometric 
    material on each no-flow filter as Mno-flow.
        (7) Using 0.01 N NaOH, wash the surfaces of the added component or 
    components which contact the aerosol flow. Determine the quantity of 
    material collected using a calibrated fluorometer. Record the mass of 
    fluorometric material collected in the wash as Mwash.
        (8) Calculate the aerosol transport as:
    
    Equation 29
    [GRAPHIC] [TIFF OMITTED] TR18JY97.091
    
    where:
    i = the active channel number.
    
        (9) Repeat paragraphs (f)(1) through (8) of this section for each 
    channel, making each channel in turn the exclusive active channel.
        (g) Test results. The candidate Class I sampler passes the aerosol 
    transport test if T(i) is at least 97 percent for each 
    channel.
    Tables to Subpart E of Part 53
    
             Table E-1.--Summary of Test Requirements for Reference and Class I Equivalent Methods for PM2.5        
    ----------------------------------------------------------------------------------------------------------------
                                                              Performance                          Part 50, Appendix
           Subpart E Procedure         Performance Test      Specification      Test Conditions       L Reference   
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.52 Sampler leak check    Sampler leak check  External leakage:   Controlled leak     Sec. 7.4.6        
     test                              facility            80 mL/min, max      flow rate of 80                      
                                                          Internal leakage:    mL/min                               
                                                           80 mL/min, max                                           
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.53 Base flow rate test   Sample flow rate:   1. 16.67 plus-      (a) 6-hour normal   Sec. 7.4.1        
                                      1. Mean              minus 5%, L/min     operational test   Sec. 7.4.2        
                                      2. Regulation       2. 2%, max           plus flow rate     Sec. 7.4.3        
                                      3. Meas. accuracy   3. 2%, max           cut-off test       Sec. 7.4.4        
                                      4. CV accuracy      4. 0.3%, max        (b) Nominal         Sec. 7.4.5        
                                      5. Cut-off          5. Flow rate cut-    conditions                           
                                                           off if flow rate   (c) Additional 55                     
                                                           deviates more       mm Hg pressure                       
                                                           than 10% from       drop to simulate                     
                                                           design flow rate    loaded filter                        
                                                           for >60 plus-      (d) Variable flow                     
                                                           minus 30 seconds    restriction used                     
                                                                               for cut-off test                     
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.54 Power interruption    Sample flow rate:   1. 16.67 plus-      (a) 6-hour normal   Sec. 7.4.1        
     test                             1. Mean              minus 5%, L/min     operational test   Sec. 7.4.2        
                                      2. Regulation       2. 2%, max          (b) Nominal         Sec. 7.4.3        
                                      3. Meas. accuracy   3. 2%, max           conditions         Sec. 7.4.5        
                                      4. CV accuracy      4. 0.3%, max        (c) Additional 55   Sec. 7.4.12       
                                      5. Occurrence time  5. plus-minus2 min   mm Hg pressure     Sec. 7.4.13       
                                       of power            if >60 seconds      drop to simulate   Sec. 7.4.15.4     
                                       interruptions      6. plus-minus20      loaded filter      Sec. 7.4.15.5     
                                      6. Elapsed sample    seconds            (d) 6 power                           
                                       time               7. plus-minus2%,     interruptions of                     
                                      7. Sample volume     max                 various durations                    
    ----------------------------------------------------------------------------------------------------------------
    
    [[Page 38812]]
    
                                                                                                                    
    Sec.  53.55 Temperature and line  Sample flow rate:   1. 16.67 plus-      (a) 6-hour normal   Sec. 7.4.1        
     voltage effect test              1. Mean              minus 5%, L/min     operational test   Sec. 7.4.2        
                                      2. Regulation       2. 2 %, max         (b) Nominal         Sec. 7.4.3        
                                      3. Meas. accuracy   3. 2 %, max          conditions         Sec. 7.4.5        
                                      4. CV accuracy      4. 0.3 %, max       (c) Additional 55   Sec. 7.4.8        
                                      5. Temperature      5. 2  deg.C          mm Hg pressure     Sec. 7.4.15.1     
                                       meas. accuracy                          drop to simulate                     
                                      6. Proper                                loaded filter                        
                                       operation                              (d) Ambient                           
                                                                               temperature at -                     
                                                                               20 and +40  deg.C                    
                                                                              (e) Line voltage:                     
                                                                               105 Vac to 125                       
                                                                               Vac                                  
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.56 Barometric pressure   Sample flow rate:   1. 16.67 plus-      (a) 6-hour normal   Sec. 7.4.1        
     effect test                      1. Mean              minus 5%, L/min     operational test   Sec. 7.4.2        
                                      2. Regulation       2. 2%, max          (b) Nominal         Sec. 7.4.3        
                                      3. Meas. accuracy   3. 2%, max           conditions         Sec. 7.4.5        
                                      4. CV accuracy      4. 0.3%, max        (c) Additional 55   Sec. 7.4.9        
                                      5. Pressure meas.   5. 10 mm Hg          mm Hg pressure                       
                                       accuracy                                drop to simulate                     
                                      6. Proper                                loaded filter                        
                                       operation                              (d) Barometric                        
                                                                               pressure at 600                      
                                                                               and 800 mm Hg.                       
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.57 Filter temperature    1. Filter temp      1. 2  deg.C         (a) 4-hour          Sec. 7.4.8        
     control test                      meas. accuracy     2. 2  deg.C          simulated solar    Sec. 7.4.10       
                                      2. Ambient temp.    3. Not more than 5   radiation,         Sec. 7.4.11       
                                       meas. accuracy       deg.C above        sampling                             
                                      3. Filter temp       ambient temp. for  (b) 4-hour                            
                                       control accuracy,   more than 30 min    simulated solar                      
                                       sampling and non-                       radiation, non-                      
                                       sampling                                sampling                             
                                                                              (c) Solar flux of                     
                                                                               1000 W/m2                            
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.58 Field precision test  1. Measurement      1. Pj <2>g/m3 for conc.    samplers at 1      Sec. 7.3.5        
                                      2. Storage           <40>g/m3   site for at least  Sec. 8            
                                       deposition test     (24-hr) or <30 10="" days="" sec.="" 9="" for="" sequential="">g/m3 (48- (b) PM2.5 conc.10 j < 5%="" for="" conc.="" m="">g/m3                               
                                                           >40 g/m3  (c) 24- or 48-hour                    
                                                           (24-hr) or >30      samples                              
                                                           g/m3 (48- (d) 5- or 10-day                      
                                                           hr)                 storage period                       
                                                          2. 50 g,    for inactive                         
                                                           max weight gain     stored filters                       
    ----------------------------------------------------------------------------------------------------------------
                                                                                                                    
                      The Following Requirement is Applicable to Candidate Equivalent Methods Only                  
                                                                                                                    
    ----------------------------------------------------------------------------------------------------------------
    Sec.  53.59 Aerosol transport     Aerosol transport   97%, min, for all   Determine aerosol                     
     test                                                  channels            transport through                    
                                                                               any new or                           
                                                                               modified                             
                                                                               components with                      
                                                                               respect to the                       
                                                                               reference method                     
                                                                               sampler before                       
                                                                               the filter for                       
                                                                               each channel.                        
    ----------------------------------------------------------------------------------------------------------------
    
    
             Table E-2.--Spectral Energy Distribution and Permitted Tolerance for Conducting Radiative Tests        
    ----------------------------------------------------------------------------------------------------------------
                                                                        Spectral Region                             
                 Chacteristic             --------------------------------------------------------------------------
                                                 Ultraviolet                Visible                  Infrared       
    ----------------------------------------------------------------------------------------------------------------
    Bandwidth (m)                 0.28 to 0.32      10.32  0.40 to 0.78             0.78 to 3.00           
                                            to 0.40                                                                 
    Irradiance (W/m2)                      5                    56  450 to 550               439                    
    Allowed Tolerance                      2 35%        2 10%        2 10%      
                                                  2                                                     
                                            25%                                                                     
    ----------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38813]]
    
    Figures to Subpart E of Part 53
    
    
    Figure E-1.--Designation Testing Checklist
    
    DESIGNATION TESTING CHECKLIST
    
    ____________________      ____________________      
    ____________________
    Auditee                 Auditor signature                 Date
    
    ----------------------------------------------------------------------------------------------------------------
           Compliance Status:    Y = Yes     N = No     NA = Not applicable/Not available                           
    ---------------------------------------------------------------------------------------------                   
                                  Verification                                Verified by Direct                    
    -------------------------------------------------------------------------   Observation of                      
                                                                                 Process or of       Verification   
                                                                                  Documented      Comments (Includes
                                                                                   Evidence:       documentation of 
                                                                                 Performance,      who, what, where,
                                                                                   Design or       when, why) (Doc. 
                    Y                          N                  NA           Application Spec.    #, Rev. #, Rev. 
                                                                               Corresponding to          Date)      
                                                                              Sections of 40 CFR                    
                                                                               Part 53 or 40 CFR                    
                                                                               Part 50, Appendix                    
                                                                                       L                            
    ----------------------------------------------------------------------------------------------------------------
                                                                              Performance                           
                                                                               Specification                        
                                                                               Tests                                
                                                                              Sample flow rate                      
                                                                               coefficient of                       
                                                                               variation (Sec.                      
                                                                               53.53) (L 7.4.3)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                              Filter temperature                    
                                                                               control                              
                                                                               (sampling) (Sec.                     
                                                                               53.57) (L 7.4.10)                    
    ----------------------------------------------------------------------------------------------------------------
                                                                              Elapsed sample                        
                                                                               time accuracy                        
                                                                               (Sec.  53.54) (L                     
                                                                               7.4.13)                              
    ----------------------------------------------------------------------------------------------------------------
                                                                              Filter temperature                    
                                                                               control (post                        
                                                                               sampling) (Sec.                      
                                                                               53.57) (L 7.4.10)                    
    ----------------------------------------------------------------------------------------------------------------
                                                                              Application                           
                                                                               Specification                        
                                                                               Tests                                
    ----------------------------------------------------------------------------------------------------------------
                                                                              Field Precision                       
                                                                               (Sec.  53.58) (L                     
                                                                               5.1)                                 
    ----------------------------------------------------------------------------------------------------------------
                                                                              Meets all Appendix                    
                                                                               L requirements                       
                                                                               (part 53, subpart                    
                                                                               A, Sec.                              
                                                                               53.2(a)(3)) (part                    
                                                                               53, subpart E,                       
                                                                               Sec.  53.51(a),(d                    
                                                                               ))                                   
    ----------------------------------------------------------------------------------------------------------------
                                                                              Filter Weighing (L-                   
                                                                               8)                                   
    ----------------------------------------------------------------------------------------------------------------
                                                                              Field Sampling                        
                                                                               Procedure (Sec.                      
                                                                               53.30, .31, .34)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                              Design                                
                                                                               Specification                        
                                                                               Tests                                
    ----------------------------------------------------------------------------------------------------------------
                                                                              Filter ( L-6)                         
    ----------------------------------------------------------------------------------------------------------------
                                                                              Range of                              
                                                                               Operational                          
                                                                               Conditions (L-                       
                                                                               7.4.7)                               
    ----------------------------------------------------------------------------------------------------------------
                                                                                                                    
                      The Following Requirements Apply Only to Class I Candidate Equivalent Methods                 
                                                                                                                    
    ----------------------------------------------------------------------------------------------------------------
                                                                              Aerosol Transport                     
                                                                               (Sec.  53.59)                        
    ----------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38814]]
    
    Figure E-2.--Product Manufacturing Checklist
    
    PRODUCT MANUFACTURING CHECKLIST
    
    ____________________      ____________________      
    ____________________
    Auditee                 Auditor signature                 Date
    
                                                                                                                    
    ----------------------------------------------------------------------------------------------------------------
           Compliance Status:    Y = Yes     N = No     NA = Not applicable/Not available                           
    ---------------------------------------------------------------------------------------------                   
                                  Verification                                Verified by Direct                    
    -------------------------------------------------------------------------   Observation of                      
                                                                                 Process or of       Verification   
                                                                                  Documented      Comments (Includes
                                                                                   Evidence:       documentation of 
                                                                                 Performance,      who, what, where,
                                                                                   Design or       when, why) (Doc. 
                    Y                          N                  NA           Application Spec.    #, Rev. #, Rev. 
                                                                               Corresponding to          Date)      
                                                                              Sections of 40 CFR                    
                                                                               Part 53 or 40 CFR                    
                                                                               Part 50, Appendix                    
                                                                                       L                            
    ----------------------------------------------------------------------------------------------------------------
                                                                              Performance                           
                                                                               Specification                        
                                                                               Tests                                
    ----------------------------------------------------------------------------------------------------------------
                                                                                Assembled                           
                                                                               operational                          
                                                                               performance (Burn-                   
                                                                               in test) (Sec.                       
                                                                               53.53)                               
    ----------------------------------------------------------------------------------------------------------------
                                                                                Sample flow rate                    
                                                                               (Sec.  53.53) (L                     
                                                                               7.4.1, L 7.4.2)                      
    ----------------------------------------------------------------------------------------------------------------
                                                                                Sample flow rate                    
                                                                               regulation (Sec.                     
                                                                               53.53) (L 7.4.3)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                                Flow rate and                       
                                                                               average flow rate                    
                                                                               measurement                          
                                                                               accuracy (Sec.                       
                                                                               53.53) (L 7.4.5)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                                Ambient air                         
                                                                               temperature                          
                                                                               measurement                          
                                                                               accuracy (Sec.                       
                                                                               53.55) (L 7.4.8)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                                Ambient                             
                                                                               barometric                           
                                                                               pressure                             
                                                                               measurement                          
                                                                               accuracy (Sec.                       
                                                                               53.56) (L 7.4.9)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                                Sample flow rate                    
                                                                               cut-off (Sec.                        
                                                                               53.53) (L 7.4.4)                     
    ----------------------------------------------------------------------------------------------------------------
                                                                                Sampler leak                        
                                                                               check facility                       
                                                                               (Sec.  53.52) (L                     
                                                                               7.4.6)                               
    ----------------------------------------------------------------------------------------------------------------
                                                                                Application                         
                                                                               Specification                        
                                                                               Tests                                
    ----------------------------------------------------------------------------------------------------------------
                                                                                Flow rate                           
                                                                               calibration                          
                                                                               transfer standard                    
                                                                               (L-9.2)                              
    ----------------------------------------------------------------------------------------------------------------
                                                                                Operational /                       
                                                                               Instructional                        
                                                                               manual (L-7.4.18)                    
    ----------------------------------------------------------------------------------------------------------------
                                                                                Design                              
                                                                               Specification                        
                                                                               Tests                                
    ----------------------------------------------------------------------------------------------------------------
                                                                                Impactor (jet                       
                                                                               width) (Sec.                         
                                                                               53.51(d)(1)) (L-                     
                                                                               7.3.4.1)                             
    ----------------------------------------------------------------------------------------------------------------
                                                                                Surface finish                      
                                                                               (Sec.  53.51(                        
                                                                               d)(2)) (L-7.3.7)                     
    ----------------------------------------------------------------------------------------------------------------
    
    Appendix A to Subpart E of Part 53--References
        (1) Quality systems--Model for quality assurance in design, 
    development, production, installation and servicing, ISO 9001. July 
    1994. Available from American Society for Quality Control, 611 East 
    Wisconsin Avenue, Milwaukee, WI 53202.
        (2) American National Standard--Specifications and Guidelines 
    for Quality Systems for Environmental Data Collection and 
    Environmental Technology Programs. ANSI/ASQC E4-1994. January 1995. 
    Available from American Society for Quality Control, 611 East 
    Wisconsin Avenue, Milwaukee, WI 53202.
        (3) Copies of section 2.12 of the Quality Assurance Handbook for 
    Air Pollution Measurement Systems, Volume II, Ambient Air Specific 
    Methods, EPA/600/R-94/038b, are available from Department E (MD-
    77B), U.S. EPA, Research Triangle Park, NC 27711.
        (4) Military standard specification (mil. spec.) 8625F, Type II, 
    Class 1 as listed in Department of Defense Index of Specifications 
    and Standards (DODISS), available from DODSSP-Customer Service, 
    Standardization Documents Order Desk, 700 Robbins Avenue, Building 
    4D, Philadelphia, PA 1911-5094.
        (5) Quality Assurance Handbook for Air Pollution Measurement 
    Systems, Volume IV: Meteorological Measurements. Revised March, 
    1995. EPA-600/R-94-038d. Available from U.S. EPA, ORD Publications 
    Office, Center for Environmental Research Information (CERI), 26 
    West Martin Luther King Drive, Cincinnati, Ohio 45268-1072 (513-569-
    7562).
        (6) Military standard specification (mil. spec.) 810-E as listed in 
    Department of Defense Index of Specifications and Standards (DODISS), 
    available from DODSSP-Customer Service, Standardization Documents Order 
    Desk, 700 Robbins Avenue, Building 4D, Philadelphia, PA 1911-5094.
        e. Subpart F is added to read as follows:
    Subpart F--Procedures for Testing Performance Characteristics of Class 
    II Equivalent Methods for PM2.5
    Sec.
    
    53.60   General provisions.
    53.61   Test conditions for PM2.5 reference method 
    equivalency.
    53.62   Test procedure: Full wind tunnel test.
    53.63   Test procedure: Wind tunnel inlet aspiration test.
    53.64   Test procedure: Static fractionator test.
    53.65   Test procedure: Loading test.
    53.66   Test procedure: Volatility test.
    Tables to Subpart F of Part 53
    Table F-1--Performance Specifications for PM2.5 Class II 
    Equivalent Samplers
    Table F-2--Particle Sizes and Wind Speeds for Full Wind Tunnel Test, 
    Wind Tunnel
    
    [[Page 38815]]
    
    Inlet Aspiration Test, and Static Chamber Test
    Table F-3--Critical Parameters of Idealized Ambient Particle Size 
    Distributions
    Table F-4--Estimated Mass Concentration Measurement of 
    PM2.5 for Idealized Coarse Aerosol Size Distribution
    Table F-5--Estimated Mass Concentration Measurement of 
    PM2.5 for Idealized ``Typical'' Coarse Aerosol Size 
    Distribution
    Table F-6 Estimated Mass Concentration Measurement of 
    PM2.5 for Idealized Fine Aerosol Size Distribution
    Figures to Subpart F of Part 53
    Figure F-1--Designation Testing Checklist
    Appendix A to Subpart F of Part 53--References
    
    Subpart F--Procedures for Testing Performance Characteristics of 
    Class II Equivalent Methods for PM2.5
    
    
    Sec. 53.60   General provisions.
    
        (a) This subpart sets forth the specific requirements that a 
    PM2.5 sampler associated with a candidate Class II 
    equivalent method must meet to be designated as an equivalent method 
    for PM2.5. This subpart also sets forth the explicit test 
    procedures that must be carried out and the test results, evidence, 
    documentation, and other materials that must be provided to EPA to 
    demonstrate that a sampler meets all specified requirements for 
    designation as an equivalent method.
        (b) A candidate method described in an application for a reference 
    or equivalent method application submitted under Sec. 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 equivalent method given in 
    Sec. 53.1.
        (c) Any sampler associated with a Class II candidate equivalent 
    method (Class II sampler) must meet all requirements for reference 
    method samplers and Class I equivalent method samplers specified in 
    subpart E of this part, as appropriate. In addition, a Class II sampler 
    must meet the additional requirements as specified in paragraph (d) of 
    this section.
        (d) Except as provided in paragraphs (d)(1), (2), and (3) of this 
    section, all Class II samplers are subject to the additional tests and 
    performance requirements specified in Sec. 53.62 (full wind tunnel 
    test), Sec. 53.65 (loading test), and Sec. 53.66 (volatility test). 
    Alternative tests and performance requirements, as described in 
    paragraphs (d)(1), (2), and (3) of this section, are optionally 
    available for certain Class II samplers which meet the requirements for 
    reference method or Class I samplers given in 40 CFR part 50, Appendix 
    L, and in subpart E of this part, except for specific deviations of the 
    inlet, fractionator, or filter.
        (1) Inlet deviation. A sampler which has been determined to be a 
    Class II sampler solely because the design or construction of its inlet 
    deviates from the design or construction of the inlet specified in 40 
    CFR part 50, Appendix L, for reference method samplers shall not be 
    subject to the requirements of Sec. 53.62 (full wind tunnel test), 
    provided that it meets all requirements of Sec. 53.63 (wind tunnel 
    inlet aspiration test), Sec. 53.65 (loading test), and Sec. 53.66 
    (volatility test).
        (2) Fractionator deviation. A sampler which has been determined to 
    be a Class II sampler solely because the design or construction of its 
    particle size fractionator deviates from the design or construction of 
    the particle size fractionator specified in 40 CFR part 50, Appendix L 
    for reference method samplers shall not be subject to the requirements 
    of Sec. 53.62 (full wind tunnel test), provided that it meets all 
    requirements of Sec. 53.64 (static fractionator test), Sec. 53.65 
    (loading test), and Sec. 53.66 (volatility test).
        (3) Filter size deviation. A sampler which has been determined to 
    be a Class II sampler solely because its effective filtration area 
    deviates from that of the reference method filter specified in 40 CFR 
    part 50, Appendix L, for reference method samplers shall not be subject 
    to the requirements of Sec. 53.62 (full wind tunnel test) nor 
    Sec. 53.65 (loading test), provided it meets all requirements of 
    Sec. 53.66 (volatility test).
        (e) The test specifications and acceptance criteria for each test 
    are summarized in Table F-1 of this subpart. The candidate sampler must 
    demonstrate performance that meets the acceptance criteria for each 
    applicable test to be designated as an equivalent method.
        (f) Overview of various test procedures for Class II samplers--(1) 
    Full wind tunnel test. This test procedure is designed to ensure that 
    the candidate sampler's effectiveness (aspiration of an ambient aerosol 
    and penetration of the sub 2.5-micron fraction to its sample filter) 
    will be comparable to that of a reference method sampler. The candidate 
    sampler is challenged at wind speeds of 2 and 24 km/hr with 
    monodisperse aerosols of the size specified in Table F-2 of this 
    subpart. The experimental test results are then integrated with three 
    idealized ambient distributions (typical, fine, and coarse) to yield 
    the expected mass concentration measurement for each. The acceptance 
    criteria are based on the results of this numerical analysis and the 
    particle diameter for which the sampler effectiveness is 50 percent.
        (2) Wind tunnel inlet aspiration test. The wind tunnel inlet 
    aspiration test directly compares the inlet of the candidate sampler to 
    the inlet of a reference method sampler with the single-sized, liquid, 
    monodisperse challenge aerosol specified in Table F-2 of this subpart 
    at wind speeds of 2 km/hr and 24 km/hr. The acceptance criteria, 
    presented in Table F-1 of this subpart, is based on the relative 
    aspiration between the candidate inlet and the reference method inlet.
        (3) Static fractionator test. The static fractionator test 
    determines the effectiveness of the candidate sampler's 2.5-micron 
    fractionator under static conditions for aerosols of the size specified 
    in Table F-2 of this subpart. The numerical analysis procedures and 
    acceptance criteria are identical to those in the full wind tunnel 
    test.
        (4) Loading test. The loading test is conducted to ensure that the 
    performance of a candidate sampler is not significantly affected by the 
    amount of particulate deposited on its interior surfaces between 
    periodic cleanings. The candidate sampler is artificially loaded by 
    sampling a test environment containing aerosolized, standard test dust. 
    The duration of the loading phase is dependent on both the time between 
    cleaning as specified by the candidate method and the aerosol mass 
    concentration in the test environment. After loading, the candidate's 
    performance must then be evaluated by Sec. 53.62 (full wind tunnel 
    evaluation), Sec. 53.64 (wind tunnel inlet aspiration test), or 
    Sec. 53.64 (static fractionator test). If the results of the 
    appropriate test meet the criteria presented in Table F-1 of this 
    subpart, then the candidate sampler passes the loading test under the 
    condition that it be cleaned at least as often as the cleaning 
    frequency proposed by the candidate method and that has been 
    demonstrated to be acceptable by this test.
        (5) Volatility test. The volatility test challenges the candidate 
    sampler with a polydisperse, semi-volatile liquid aerosol. This aerosol 
    is simultaneously sampled by the candidate method sampler and a 
    reference method sampler for a specified time period. Clean air is then 
    passed through the samplers during a blow-off time period. Residual 
    mass is then calculated as the weight of the filter after the blow-off 
    phase is subtracted from the initial weight of the filter. Acceptance 
    criteria are based on a comparison of the residual mass measured by the 
    candidate sampler (corrected for flow rate variations from that of the 
    reference method) to the
    
    [[Page 38816]]
    
    residual mass measured by the reference method sampler for several 
    specified clean air sampling time periods.
        (g) Test data. All test data and other documentation obtained from 
    or pertinent to these tests shall be identified, dated, signed by the 
    analyst performing the test, and submitted to EPA as part of the 
    equivalent method application. Schematic drawings of each particle 
    delivery system and other information showing complete procedural 
    details of the test atmosphere generation, verification, and delivery 
    techniques for each test performed shall be submitted to EPA. All 
    pertinent calculations shall be clearly presented. In addition, 
    manufacturers are required to submit as part of the application, a 
    Designation Testing Checklist (Figure F-1 of this subpart) which has 
    been completed and signed by an ISO-certified auditor.
    
    
    Sec. 53.61   Test conditions for PM2.5 reference method 
    equivalency.
    
        (a) Sampler surface preparation. Internal surfaces of the candidate 
    sampler shall be cleaned and dried prior to performing any Class II 
    sampler test in this subpart. The internal collection surfaces of the 
    sampler shall then be prepared in strict accordance with the operating 
    instructions specified in the sampler's operating manual referred to in 
    section 7.4.18 of 40 CFR part 50, Appendix L.
        (b) Sampler setup. 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 section 7.4.18 of 40 CFR part 50, Appendix L, 
    unless otherwise specified within this subpart.
        (c) Sampler adjustments. Once the test sampler or samplers have 
    been set up and the performance tests started, manual adjustment shall 
    be permitted only between test points for all applicable tests. Manual 
    adjustments and any periodic maintenance shall be limited to only those 
    procedures prescribed in the manual referred to in section 7.4.18 of 40 
    CFR part 50, Appendix L. The submitted records shall clearly indicate 
    when any manual adjustment or periodic maintenance was made and shall 
    describe the operations performed.
        (d) Sampler malfunctions. If a test sampler malfunctions during any 
    of the applicable tests, that test run shall be repeated. A detailed 
    explanation of all malfunctions and the remedial actions taken shall be 
    submitted as part of the equivalent method application.
        (e) Particle concentration measurements. All measurements of 
    particle concentration must be made such that the relative error in 
    measurement is less than 5.0 percent. Relative error is defined as (s 
    x  100 percent)/(X), where s is the sample standard deviation of the 
    particle concentration detector, X is the measured concentration, and 
    the units of s and X are identical.
        (f) Operation of test measurement equipment. All test measurement 
    equipment shall be set up, calibrated, and maintained by qualified 
    personnel according to the manufacturer's instructions. All appropriate 
    calibration information and manuals for this equipment shall be kept on 
    file.
        (g) Vibrating orifice aerosol generator conventions. This section 
    prescribes conventions regarding the use of the vibrating orifice 
    aerosol generator (VOAG) for the size-selective performance tests 
    outlined in Secs. 53.62, 53.63, 53.64, and 53.65.
        (1) Particle aerodynamic diameter. The VOAG produces near-
    monodisperse droplets through the controlled breakup of a liquid jet. 
    When the liquid solution consists of a non-volatile solute dissolved in 
    a volatile solvent, the droplets dry to form particles of near-
    monodisperse size.
        (i) The physical diameter of a generated spherical particle can be 
    calculated from the operating parameters of the VOAG as:
    
    Equation 1
    [GRAPHIC] [TIFF OMITTED] TR18JY97.094
    
    where:
    Dp = particle physical diameter, m;
    Q = liquid volumetric flow rate, m3/sec;
    Cvol = volume concentration (particle volume produced per 
    drop volume), dimensionless; and
    f = frequency of applied vibrational signal, 1/sec.
    
        (ii) A given particle's aerodynamic behavior is a function of its 
    physical particle size, particle shape, and density. Aerodynamic 
    diameter is defined as the diameter of a unit density 
    (o = 1 g/m3) sphere having the same 
    settling velocity as the particle under consideration. For converting a 
    spherical particle of known density to aerodynamic diameter, the 
    governing relationship is:
    
    Equation 2
    [GRAPHIC] [TIFF OMITTED] TR18JY97.095
    
    where:
    Dae = particle aerodynamic diameter, m;
    p = particle density, g/cm3;
    o = aerodynamic particle density = 1 g/
    m3;
    CDp = Cunningham's slip correction factor for physical 
    particle diameter, dimensionless; and
    CDae = Cunningham's slip correction factor for 
    aerodynamic particle diameter, dimensionless.
    
        (iii) At room temperature and standard pressure, the Cunningham's 
    slip correction factor is solely a function of particle diameter:
    
    Equation 3
    [GRAPHIC] [TIFF OMITTED] TR18JY97.096
    
    or
    
    Equation 4
    [GRAPHIC] [TIFF OMITTED] TR18JY97.097
    
        (iv) Since the slip correction factor is itself a function of 
    particle diameter, the aerodynamic diameter in Equation 2 of paragraph 
    (g)(1)(ii) of this section cannot be solved directly but must be 
    determined by iteration.
        (2) Solid particle generation. (i) Solid particle tests performed 
    in this subpart shall be conducted using particles composed of ammonium 
    fluorescein. For use in the VOAG, liquid solutions of known volumetric 
    concentration can be prepared by diluting fluorescein powder 
    (C20H12O5, FW = 332.31, CAS 2321-07-5) 
    with aqueous ammonia. Guidelines for preparation of fluorescein 
    solutions of the desired volume concentration (Cvol) are 
    presented by Vanderpool and Rubow (1988) (Reference 2 in Appendix A of 
    this subpart). For purposes of converting particle physical diameter to 
    aerodynamic diameter, an ammonium fluorescein density of 1.35 g/
    cm3 shall be used.
        (ii) Mass deposits of ammonium fluorescein shall be extracted and 
    analyzed using solutions of 0.01 N ammonium hydroxide.
        (3) Liquid particle generation. (i) Tests prescribed in Sec. 53.63 
    for inlet aspiration require the use of liquid particle tests composed 
    of oleic acid tagged with uranine to enable subsequent fluorometric 
    quantitation of collected aerosol mass deposits. Oleic acid 
    (C18H34O2, FW = 282.47, CAS 112-80-1) 
    has a density of 0.8935 g/cm3. Because the viscosity of 
    oleic acid is relatively high, significant errors can occur when 
    dispensing oleic acid using volumetric pipettes. For this reason, it is 
    recommended that oleic acid solutions be prepared by quantifying 
    dispensed oleic acid gravimetrically. The volume of oleic acid 
    dispensed can then be calculated simply by dividing the
    
    [[Page 38817]]
    
    dispensed mass by the oleic acid density.
        (ii) Oleic acid solutions tagged with uranine shall be prepared as 
    follows. A known mass of oleic acid shall first be diluted using 
    absolute ethanol. The desired mass of the uranine tag should then be 
    diluted in a separate container using absolute ethanol. Uranine 
    (C20H10O5Na2, FW = 376.3, 
    CAS 518-47-8) is the disodium salt of fluorescein and has a density of 
    1.53 g/cm3. In preparing uranine tagged oleic acid 
    particles, the uranine content shall not exceed 20 percent on a mass 
    basis. Once both oleic acid and uranine solutions are properly 
    prepared, they can then be combined and diluted to final volume using 
    absolute ethanol.
        (iii) Calculation of the physical diameter of the particles 
    produced by the VOAG requires knowledge of the liquid solution's volume 
    concentration (Cvol). Because uranine is essentially 
    insoluble in oleic acid, the total particle volume is the sum of the 
    oleic acid volume and the uranine volume. The volume concentration of 
    the liquid solution shall be calculated as:
    
    Equation 5
    [GRAPHIC] [TIFF OMITTED] TR18JY97.098
    
    where:
    Vu = uranine volume, ml;
    Voleic = oleic acid volume, ml;
    Vsol = total solution volume, ml;
    Mu = uranine mass, g;
    u = uranine density, g/cm3;
    Moleic = oleic acid mass, g; and
    oleic = oleic acid density, g/cm3.
    
        (iv) For purposes of converting the particles' physical diameter to 
    aerodynamic diameter, the density of the generated particles shall be 
    calculated as:
    
    Equation 6
    [GRAPHIC] [TIFF OMITTED] TR18JY97.099
    
        (v) Mass deposits of oleic acid shall be extracted and analyzed 
    using solutions of 0.01 N sodium hydroxide.
    
    
    Sec. 53.62   Test procedure: Full wind tunnel test.
    
        (a) Overview. The full wind tunnel test evaluates the effectiveness 
    of the candidate sampler at 2 km/hr and 24 km/hr for aerosols of the 
    size specified in Table F-2 of this subpart (under the heading, ``Full 
    Wind Tunnel Test''). For each wind speed, a smooth curve is fit to the 
    effectiveness data and corrected for the presence of multiplets in the 
    wind tunnel calibration aerosol. The cutpoint diameter 
    (Dp50) at each wind speed is then determined from the 
    corrected effectiveness curves. The two resultant penetration curves 
    are then each numerically integrated with three idealized ambient 
    particle size distributions to provide six estimates of measured mass 
    concentration. Critical parameters for these idealized distributions 
    are presented in Table F-3 of this subpart.
        (b) Technical definitions. Effectiveness is the ratio (expressed as 
    a percentage) of the mass concentration of particles of a specific size 
    reaching the sampler filter or filters to the mass concentration of 
    particles of the same size approaching the sampler.
        (c) Facilities and equipment required--(1) Wind tunnel. The 
    particle delivery system shall consist of a blower system and a wind 
    tunnel having a test section of sufficiently large cross-sectional area 
    such that the test sampler, or portion thereof, as installed in the 
    test section for testing, blocks no more than 15 percent of the test 
    section area. The wind tunnel blower system must be capable of 
    maintaining uniform wind speeds at the 2 km/hr and 24 km/hr in the test 
    section.
        (2) Aerosol generation system. A vibrating orifice aerosol 
    generator shall be used to produce monodisperse solid particles of 
    ammonium fluorescein with equivalent aerodynamic diameters as specified 
    in Table F-2 of this subpart. The geometric standard deviation for each 
    particle size generated shall not exceed 1.1 (for primary particles) 
    and the proportion of multiplets (doublets and triplets) in all test 
    particle atmosphere shall not exceed 10 percent of the particle 
    population. The aerodynamic particle diameter, as established by the 
    operating parameters of the vibrating orifice aerosol generator, shall 
    be within the tolerance specified in Table F-2 of this subpart.
        (3) Particle size verification equipment. The size of the test 
    particles shall be verified during this test by use of a suitable 
    instrument (e.g., scanning electron microscope, optical particle sizer, 
    time-of-flight apparatus). The instrument must be capable of measuring 
    solid and liquid test particles with a size resolution of 0.1 
    m or less. The accuracy of the particle size verification 
    technique shall be 0.15 m or better.
        (4) Wind speed measurement. The wind speed in the wind tunnel shall 
    be determined during the tests using an appropriate technique capable 
    of a precision of 2 percent and an accuracy of 5 percent or better 
    (e.g., hot-wire anemometry). For the wind speeds specified in Table F-2 
    of this subpart, the wind speed shall be measured at a minimum of 12 
    test points in a cross-sectional area of the test section of the wind 
    tunnel. The mean wind speed in the test section must be within 
     10 percent of the value specified in Table F-2 of this 
    subpart, and the variation at any test point in the test section may 
    not exceed 10 percent of the measured mean.
        (5) Aerosol rake. The cross-sectional uniformity of the particle 
    concentration in the sampling zone of the test section shall be 
    established during the tests using an array of isokinetic samplers, 
    referred to as a rake. Not less than five evenly spaced isokinetic 
    samplers shall be used to determine the particle concentration spatial 
    uniformity in the sampling zone. The sampling zone shall be a 
    rectangular area having a horizontal dimension not less than 1.2 times 
    the width of the test sampler at its inlet opening and a vertical 
    dimension not less than 25 centimeters.
        (6) Total aerosol isokinetic sampler. After cross-sectional 
    uniformity has been confirmed, a single isokinetic sampler may be used 
    in place of the array of isokinetic samplers for the determination of 
    particle mass concentration used in the calculation of sampling 
    effectiveness of the test sampler in paragraph (d)(5) of this section. 
    In this case, the array of isokinetic samplers must be used to 
    demonstrate particle concentration uniformity prior to the replicate 
    measurements of sampling effectiveness.
        (7) Fluorometer. A fluorometer used for quantifying extracted 
    aerosol mass deposits shall be set up, maintained, and calibrated 
    according to the manufacturer's instructions. A series of calibration 
    standards shall be prepared to encompass the minimum and maximum 
    concentrations measured during size-selective tests. Prior to each 
    calibration and measurement, the fluorometer shall be zeroed using an 
    aliquot of the same solvent used for extracting aerosol mass deposits.
        (8) Sampler flow rate measurements. All flow rate measurements used 
    to calculate the test atmosphere concentrations and the test results 
    must be accurate to within  2 percent, referenced to a 
    NIST-traceable primary standard. Any necessary flow rate measurement 
    corrections shall be clearly documented. All flow rate measurements 
    shall be performed and reported in actual volumetric units.
        (d) Test procedures--(1) Establish and verify wind speed. (i) 
    Establish a wind speed specified in Table F-2 of this subpart.
    
    [[Page 38818]]
    
        (ii) Measure the wind speed at a minimum of 12 test points in a 
    cross-sectional area of the test section of the wind tunnel using a 
    device as described in paragraph (c)(4) of this section.
        (iii) Verify that the mean wind speed in the test section of the 
    wind tunnel during the tests is within 10 percent of the value 
    specified in Table F-2 of this subpart. The wind speed measured at any 
    test point in the test section shall not differ by more than 10 percent 
    from the mean wind speed in the test section.
        (2) Generate aerosol. (i) Generate particles of a size specified in 
    Table F-2 of this subpart using a vibrating orifice aerosol generator.
        (ii) Check for the presence of satellites and adjust the generator 
    as necessary.
        (iii) Calculate the physical particle size using the operating 
    parameters of the vibrating orifice aerosol generator and record.
        (iv) Determine the particle's aerodynamic diameter from the 
    calculated physical diameter and the known density of the generated 
    particle. The calculated aerodynamic diameter must be within the 
    tolerance specified in Table F-2 of this subpart.
        (3) Introduce particles into the wind tunnel. Introduce the 
    generated particles into the wind tunnel and allow the particle 
    concentration to stabilize.
        (4) Verify the quality of the test aerosol. (i) Extract a 
    representative sample of the aerosol from the sampling test zone and 
    measure the size distribution of the collected particles using an 
    appropriate sizing technique. If the measurement technique does not 
    provide a direct measure of aerodynamic diameter, the geometric mean 
    aerodynamic diameter of the challenge aerosol must be calculated using 
    the known density of the particle and the measured mean physical 
    diameter. The determined geometric mean aerodynamic diameter of the 
    test aerosol must be within 0.15 m of the aerodynamic diameter 
    calculated from the operating parameters of the vibrating orifice 
    aerosol generator. The geometric standard deviation of the primary 
    particles must not exceed 1.1.
        (ii) Determine the population of multiplets in the collected 
    sample. The multiplet population of the particle test atmosphere must 
    not exceed 10 percent of the total particle population.
        (5) Aerosol uniformity and concentration measurement. (i) Install 
    an array of five or more evenly spaced isokinetic samplers in the 
    sampling zone (paragraph (c)(5) of this section). Collect particles on 
    appropriate filters over a time period such that the relative error of 
    the measured particle concentration is less than 5.0 percent.
        (ii) Determine the quantity of material collected with each 
    isokinetic sampler in the array using a calibrated fluorometer. 
    Calculate and record the mass concentration for each isokinetic sampler 
    as:
    
    Equation 7
    [GRAPHIC] [TIFF OMITTED] TR18JY97.100
    
    where:
    i = replicate number;
    j = isokinetic sampler number;
    Miso = mass of material collected with the isokinetic 
    sampler;
    Q = isokinetic sampler volumetric flow rate; and
    t = sampling time.
    
        (iii) Calculate and record the mean mass concentration as:
    
    Equation 8
    [GRAPHIC] [TIFF OMITTED] TR18JY97.101
    
    where:
    i = replicate number;
    j = isokinetic sampler number; and
    n = total number of isokinetic samplers.
    
        (iv) Precision calculation. (A) Calculate the coefficient of 
    variation of the mass concentration measurements as:
    
    Equation 9
    [GRAPHIC] [TIFF OMITTED] TR18JY97.102
    
    where:
    i = replicate number;
    j = isokinetic sampler number; and
    n = total number of isokinetic samplers.
    
        (B) If the value of CViso(i) for any replicate exceeds 
    10 percent, the particle concentration uniformity is unacceptable and 
    step 5 must be repeated. If adjustment of the vibrating orifice aerosol 
    generator or changes in the particle delivery system are necessary to 
    achieve uniformity, steps 1 through 5 must be repeated. When an 
    acceptable aerosol spatial uniformity is achieved, remove the array of 
    isokinetic samplers from the wind tunnel.
        (6) Alternative measure of wind tunnel total concentration. If a 
    single isokinetic sampler is used to determine the mean aerosol 
    concentration in the wind tunnel, install the sampler in the wind 
    tunnel with the sampler nozzle centered in the sampling zone (paragraph 
    (c)(6) of this section).
        (i) Collect particles on an appropriate filter over a time period 
    such that the relative error of the measured concentration is less than 
    5.0 percent.
        (ii) Determine the quantity of material collected with the 
    isokinetic sampler using a calibrated fluorometer.
        (iii) Calculate and record the mass concentration as 
    Ciso(i) as in paragraph (d)(5)(ii) of this section.
        (iv) Remove the isokinetic sampler from the wind tunnel.
        (7) Measure the aerosol with the candidate sampler. (i) Install the 
    test sampler (or portion thereof) in the wind tunnel with the sampler 
    inlet opening centered in the sampling zone. To meet the maximum 
    blockage limit of paragraph (c)(1) of this section or for convenience, 
    part of the test sampler may be positioned external to the wind tunnel 
    provided that neither the geometry of the sampler nor the length of any 
    connecting tube or pipe is altered. Collect particles for a time period 
    such that the relative error of the measured concentration is less than 
    5.0 percent.
        (ii) Remove the test sampler from the wind tunnel.
        (iii) Determine the quantity of material collected with the test 
    sampler using a calibrated fluorometer. Calculate and record the mass 
    concentration for each replicate as:
    
    Equation 10
    [GRAPHIC] [TIFF OMITTED] TR18JY97.103
    
    where:
    i = replicate number;
    Mcand = mass of material collected with the candidate 
    sampler;
    Q = candidate sampler volumetric flow rate; and
    t = sampling time.
    
    
    [[Page 38819]]
    
    
        (iv)(A) Calculate and record the sampling effectiveness of the 
    candidate sampler as:
    
    Equation 11
    [GRAPHIC] [TIFF OMITTED] TR18JY97.104
    
    where:
    i = replicate number.
    
        (B) If a single isokinetic sampler is used for the determination of 
    particle mass concentration, replace Ciso(i) with 
    Ciso.
        (8) Replicate measurements and calculation of mean sampling 
    effectiveness. (i) Repeat steps in paragraphs (d)(5) through (d)(7) of 
    this section, as appropriate, to obtain a minimum of three valid 
    replicate measurements of sampling effectiveness.
        (ii) Calculate and record the average sampling effectiveness of the 
    test sampler for the particle size as:
    
    Equation 12
    [GRAPHIC] [TIFF OMITTED] TR18JY97.105
    
    where:
    i = replicate number; and
    n = number of replicates.
    
        (iii) Sampling effectiveness precision. (A) Calculate and record 
    the coefficient of variation for the replicate sampling effectiveness 
    measurements of the test sampler as:
    
    Equation 13
    [GRAPHIC] [TIFF OMITTED] TR18JY97.106
    
    where:
    i = replicate number, and
    n = number of replicates.
    
        (B) If the value of CVE exceeds 10 percent, the test run 
    (steps in paragraphs (d)(2) through (d)(8) of this section) must be 
    repeated until an acceptable value is obtained.
        (9) Repeat steps in paragraphs (d)(2) through (d)(8) of this 
    section until the sampling effectiveness has been measured for all 
    particle sizes specified in Table F-2 of this subpart.
        (10) Repeat steps in paragraphs (d)(1) through (d)(9) of this 
    section until tests have been successfully conducted for both wind 
    speeds of 2 km/hr and 24 km/hr.
        (e) Calculations--(1) Graphical treatment of effectiveness data. 
    For each wind speed given in Table F-2 of this subpart, plot the 
    particle average sampling effectiveness of the candidate sampler as a 
    function of aerodynamic particle diameter (Dae) on semi-
    logarithmic graph paper where the aerodynamic particle diameter is the 
    particle size established by the parameters of the VOAG in conjunction 
    with the known particle density. Construct a best-fit, smooth curve 
    through the data by extrapolating the sampling effectiveness curve 
    through 100 percent at an aerodynamic particle size of 0.5 m 
    and 0 percent at an aerodynamic particle size of 10 m. 
    Correction for the presence of multiplets shall be performed using the 
    techniques presented by Marple, et al (1987). This multiplet-corrected 
    effectiveness curve shall be used for all remaining calculations in 
    this paragraph (e).
        (2) Cutpoint determination. For each wind speed determine the 
    sampler Dp50 cutpoint defined as the aerodynamic particle 
    size corresponding to 50 percent effectiveness from the multiplet 
    corrected smooth curve.
        (3) Expected mass concentration calculation. For each wind speed, 
    calculate the estimated mass concentration measurement for the test 
    sampler under each particle size distribution (Tables F-4, F-5, and F-6 
    of this subpart) and compare it to the mass concentration predicted for 
    the reference sampler as follows:
        (i) Determine the value of corrected effectiveness using the best-
    fit, multiplet-corrected curve at each of the particle sizes specified 
    in the first column of Table F-4 of this subpart. Record each corrected 
    effectiveness value as a decimal between 0 and 1 in column 2 of Table 
    F-4 of this subpart.
        (ii) Calculate the interval estimated mass concentration 
    measurement by multiplying the values of corrected effectiveness in 
    column 2 by the interval mass concentration values in column 3 and 
    enter the products in column 4 of Table F-4 of this subpart.
        (iii) Calculate the estimated mass concentration measurement by 
    summing the values in column 4 and entering the total as the estimated 
    mass concentration measurement for the test sampler at the bottom of 
    column 4 of Table F-4 of this subpart.
        (iv) Calculate the estimated mass concentration ratio between the 
    candidate method and the reference method as:
    
    Equation 14
    [GRAPHIC] [TIFF OMITTED] TR18JY97.107
    
    where:
    Ccand(est) = estimated mass concentration measurement for 
    the test sampler, g/m3; and
    Cref(est) = estimated mass concentration measurement for 
    the reference sampler, g/m3 (calculated for the 
    reference sampler and specified at the bottom of column 7 of Table 
    F-4 of this subpart).
    
        (v) Repeat steps in paragraphs (e) (1) through (e)(3) of this 
    section for Tables F-5 and F-6 of this subpart.
        (f) Evaluation of test results. The candidate method passes the 
    wind tunnel effectiveness test if the Rc value for each wind 
    speed meets the specification in Table F-1 of this subpart for each of 
    the three particle size distributions.
    
    
    Sec. 53.63   Test procedure: Wind tunnel inlet aspiration test.
    
        (a) Overview. This test applies to a candidate sampler which 
    differs from the reference method sampler only with respect to the 
    design of the inlet. The purpose of this test is to ensure that the 
    aspiration of a Class II candidate sampler is such that it 
    representatively extracts an ambient aerosol at elevated wind speeds. 
    This wind tunnel test uses a single-sized, liquid aerosol in 
    conjunction with wind speeds of 2 km/hr and 24 km/hr. The test 
    atmosphere concentration is alternately measured with the candidate 
    sampler and a reference method device, both of which are operated 
    without the 2.5-micron fractionation device installed. The test 
    conditions are summarized in Table F-2 of this subpart (under the 
    heading of ``wind tunnel inlet aspiration test''). The candidate 
    sampler must meet or exceed the acceptance criteria given in Table F-1 
    of this subpart.
        (b) Technical definition. Relative aspiration is the ratio 
    (expressed as a percentage) of the aerosol mass concentration measured 
    by the candidate sampler to that measured by a reference method 
    sampler.
        (c) Facilities and equipment required. The facilities and equipment 
    are identical to those required for the full wind tunnel test 
    (Sec. 53.62(c)).
        (d) Setup. The candidate and reference method samplers shall be 
    operated with the PM2.5 fractionation device removed from 
    the flow path throughout this entire test procedure. Modifications to 
    accommodate this requirement shall be limited to removal of the 
    fractionator and insertion of the filter holder directly into the 
    downtube of the inlet.
        (e) Test procedure--(1) Establish the wind tunnel test atmosphere. 
    Follow the procedures in Sec. 53.62(d)(1) through (d)(4) to establish a 
    test atmosphere for one of the two wind speeds specified in Table F-2 
    of this subpart.
    
    [[Page 38820]]
    
        (2) Measure the aerosol concentration with the reference sampler. 
    (i) Install the reference sampler (or portion thereof) in the wind 
    tunnel with the sampler inlet opening centered in the sampling zone. To 
    meet the maximum blockage limit of Sec. 53.62(c)(1) or for convenience, 
    part of the test sampler may be positioned external to the wind tunnel 
    provided that neither the geometry of the sampler nor the length of any 
    connecting tube or pipe is altered. Collect particles for a time period 
    such that the relative error of the measured concentration is less than 
    5.0 percent.
        (ii) Determine the quantity of material collected with the 
    reference method sampler using a calibrated fluorometer. Calculate and 
    record the mass concentration as:
    
    Equation 15
    [GRAPHIC] [TIFF OMITTED] TR18JY97.108
    
    where:
    i = replicate number;
    Mref = mass of material collected with the reference 
    method sampler;
    Q = reference method sampler volumetric flow rate; and
    t = sampling time.
    
        (iii) Remove the reference method sampler from the tunnel.
        (3) Measure the aerosol concentration with the candidate sampler. 
    (i) Install the candidate sampler (or portion thereof) in the wind 
    tunnel with the sampler inlet centered in the sampling zone. To meet 
    the maximum blockage limit of Sec. 53.62(c)(1) or for convenience, part 
    of the test sampler may be positioned external to the wind tunnel 
    provided that neither the geometry of the sampler nor the length of any 
    connecting tube or pipe is altered. Collect particles for a time period 
    such that the relative error of the measured concentration is less than 
    5.0 percent.
        (ii) Determine the quantity of material collected with the 
    candidate sampler using a calibrated fluorometer. Calculate and record 
    the mass concentration as:
    
    Equation 16
    [GRAPHIC] [TIFF OMITTED] TR18JY97.109
    
    where:
    i = replicate number;
    Mcand = mass of material collected with the candidate 
    sampler;
    Q = candidate sampler volumetric flow rate; and
    t = sampling time.
    
        (iii) Remove the candidate sampler from the wind tunnel.
        (4) Repeat steps in paragraphs (d) (2) and (d)(3) of this section. 
    Alternately measure the tunnel concentration with the reference sampler 
    and the candidate sampler until four reference sampler and three 
    candidate sampler measurements of the wind tunnel concentration are 
    obtained.
        (5) Calculations. (i) Calculate and record aspiration ratio for 
    each candidate sampler run as:
    
    Equation 17
    [GRAPHIC] [TIFF OMITTED] TR18JY97.110
    
    where:
    i = replicate number.
    
        (ii) Calculate and record the mean aspiration ratio as:
    
    Equation 18
    [GRAPHIC] [TIFF OMITTED] TR18JY97.111
    
    where:
    i = replicate number; and
    n = total number of measurements of aspiration ratio.
    
        (iii) Precision of the aspiration ratio. (A) Calculate and record 
    the precision of the aspiration ratio measurements as the coefficient 
    of variation as:
    
    Equation 19
    [GRAPHIC] [TIFF OMITTED] TR18JY97.112
    
    where:
    i = replicate number; and
    n = total number of measurements of aspiration ratio.
    
        (B) If the value of CVA exceeds 10 percent, the entire 
    test procedure must be repeated.
        (f) Evaluation of test results. The candidate method passes the 
    inlet aspiration test if all values of A meet the acceptance criteria 
    specified in Table F-1 of this subpart.
    
    
    Sec. 53.64   Test procedure: Static fractionator test.
    
        (a) Overview. This test applies only to those candidate methods in 
    which the sole deviation from the reference method is in the design of 
    the 2.5-micron fractionation device. The purpose of this test is to 
    ensure that the fractionation characteristics of the candidate 
    fractionator are acceptably similar to that of the reference method 
    sampler. It is recognized that various methodologies exist for 
    quantifying fractionator effectiveness. The following commonly-employed 
    techniques are provided for purposes of guidance. Other methodologies 
    for determining sampler effectiveness may be used contingent upon prior 
    approval by the Agency.
        (1) Wash-off method. Effectiveness is determined by measuring the 
    aerosol mass deposited on the candidate sampler's after filter versus 
    the aerosol mass deposited in the fractionator. The material deposited 
    in the fractionator is recovered by washing its internal surfaces. For 
    these wash-off tests, a fluorometer must be used to quantitate the 
    aerosol concentration. Note that if this technique is chosen, the 
    candidate must be reloaded with coarse aerosol prior to each test point 
    when reevaluating the curve as specified in the loading test.
        (2) Static chamber method. Effectiveness is determined by measuring 
    the aerosol mass concentration sampled by the candidate sampler's after 
    filter versus that which exists in a static chamber. A calibrated 
    fluorometer shall be used to quantify the collected aerosol deposits. 
    The aerosol concentration is calculated as the measured aerosol mass 
    divided by the sampled air volume.
        (3) Divided flow method. Effectiveness is determined by comparing 
    the aerosol concentration upstream of the candidate sampler's 
    fractionator versus that concentration which exists downstream of the 
    candidate fractionator. These tests may utilize either fluorometry or a 
    real-time aerosol measuring device to determine the aerosol 
    concentration.
        (b) Technical definition. Effectiveness under static conditions is 
    the ratio (expressed as a percentage) of the mass concentration of 
    particles of a given size reaching the sampler filter to the mass 
    concentration of particles of the same size existing in the test 
    atmosphere.
        (c) Facilities and equipment required--(1) Aerosol generation. 
    Methods for generating aerosols shall be identical to those prescribed 
    in Sec. 53.62(c)(2).
        (2) Particle delivery system. Acceptable apparatus for delivering 
    the generated aerosols to the candidate fractionator is dependent on 
    the effectiveness measurement methodology and shall be defined as 
    follows:
        (i) Wash-off test apparatus. The aerosol may be delivered to the 
    candidate fractionator through direct piping (with or without an in-
    line mixing chamber). Validation particle size and quality shall be 
    conducted at a point directly upstream of the fractionator.
    
    [[Page 38821]]
    
        (ii) Static chamber test apparatus. The aerosol shall be introduced 
    into a chamber and sufficiently mixed such that the aerosol 
    concentration within the chamber is spatially uniform. The chamber must 
    be of sufficient size to house at least four total filter samplers in 
    addition to the inlet of the candidate method size fractionator. 
    Validation of particle size and quality shall be conducted on 
    representative aerosol samples extracted from the chamber.
        (iii) Divided flow test apparatus. The apparatus shall allow the 
    aerosol concentration to be measured upstream and downstream of the 
    fractionator. The aerosol shall be delivered to a manifold with two 
    symmetrical branching legs. One of the legs, referred to as the bypass 
    leg, shall allow the challenge aerosol to pass unfractionated to the 
    detector. The other leg shall accommodate the fractionation device.
        (3) Particle concentration measurement--(i) Fluorometry. Refer to 
    Sec. 53.62(c)(7).
        (ii) Number concentration measurement. A number counting particle 
    sizer may be used in conjunction with the divided flow test apparatus 
    in lieu of fluorometric measurement. This device must have a minimum 
    range of 1 to 10 m, a resolution of 0.1 m, and an 
    accuracy of 0.15 m such that primary particles may be 
    distinguished from multiplets for all test aerosols. The measurement of 
    number concentration shall be accomplished by integrating the primary 
    particle peak.
        (d) Setup--(1) Remove the inlet and downtube from the candidate 
    fractionator. All tests procedures shall be conducted with the inlet 
    and downtube removed from the candidate sampler.
        (2) Surface treatment of the fractionator. Rinsing aluminum 
    surfaces with alkaline solutions has been found to adversely affect 
    subsequent fluorometric quantitation of aerosol mass deposits. If wash-
    off tests are to be used for quantifying aerosol penetration, internal 
    surfaces of the fractionator must first be plated with electroless 
    nickel. Specifications for this plating are specified in Society of 
    Automotive Engineers Aerospace Material Specification (SAE AMS) 2404C, 
    Electroless Nickel Plating (Reference 3 in Appendix A of Subpart F).
        (e) Test procedure: Wash-off method--(1) Clean the candidate 
    sampler. Note: The procedures in this step may be omitted if this test 
    is being used to evaluate the fractionator after being loaded as 
    specified in Sec. 53.65.
        (i) Clean and dry the internal surfaces of the candidate sampler.
        (ii) Prepare the internal fractionator surfaces in strict 
    accordance with the operating instructions specified in the sampler's 
    operating manual referred to in section 7.4.18 of 40 CFR part 50, 
    Appendix L.
        (2) Generate aerosol. Follow the procedures for aerosol generation 
    prescribed in Sec. 53.62(d)(2).
        (3) Verify the quality of the test aerosol. Follow the procedures 
    for verification of test aerosol size and quality prescribed in 
    Sec. 53.62(d)(4).
        (4) Determine effectiveness for the particle size being produced. 
    (i) Collect particles downstream of the fractionator on an appropriate 
    filter over a time period such that the relative error of the 
    fluorometric measurement is less than 5.0 percent.
        (ii) Determine the quantity of material collected on the after 
    filter of the candidate method using a calibrated fluorometer. 
    Calculate and record the aerosol mass concentration for the sampler 
    filter as:
    
    Equation 20
    [GRAPHIC] [TIFF OMITTED] TR18JY97.113
    
    where:
    i = replicate number;
    Mcand = mass of material collected with the candidate 
    sampler;
    Q = candidate sampler volumetric flowrate; and
    t = sampling time.
    
        (iii) Wash all interior surfaces upstream of the filter and 
    determine the quantity of material collected using a calibrated 
    fluorometer. Calculate and record the fluorometric mass concentration 
    of the sampler wash as:
    
    Equation 21
    [GRAPHIC] [TIFF OMITTED] TR18JY97.114
    
    where:
    i = replicate number;
    Mwash = mass of material washed from the interior 
    surfaces of the fractionator;
    Q = candidate sampler volumetric flowrate; and
    t = sampling time.
    
    (iv) Calculate and record the sampling effectiveness of the test 
    sampler for this particle size as:
    
    Equation 22
    [GRAPHIC] [TIFF OMITTED] TR18JY97.115
    
    where:
    i = replicate number.
    
        (v) Repeat steps in paragraphs (e)(4) of this section, as 
    appropriate, to obtain a minimum of three replicate measurements of 
    sampling effectiveness. Note: The procedures for loading the candidate 
    in Sec. 53.65 must be repeated between repetitions if this test is 
    being used to evaluate the fractionator after being loaded as specified 
    in Sec. 53.65.
        (vi) Calculate and record the average sampling effectiveness of the 
    test sampler as:
    
    Equation 23
    [GRAPHIC] [TIFF OMITTED] TR18JY97.116
    
    where:
    i = replicate number; and
    n = number of replicates.
    
        (vii)(A) Calculate and record the coefficient of variation for the 
    replicate sampling effectiveness measurements of the test sampler as:
    
    Equation 24
    [GRAPHIC] [TIFF OMITTED] TR18JY97.117
    
    where:
    i = replicate number; and
    n = total number of measurements.
        (B) If the value of CVE exceeds 10 percent, then steps 
    in paragraphs (e) (2) through (e)(4) of this section must be repeated.
        (5) Repeat steps in paragraphs (e) (1) through (e)(4) of this 
    section for each particle size specified in Table F-2 of this subpart.
        (f) Test procedure: Static chamber method--(1) Generate aerosol. 
    Follow the procedures for aerosol generation prescribed in 
    Sec. 53.62(d)(2).
        (2) Verify the quality of the test aerosol. Follow the procedures 
    for verification of test aerosol size and quality prescribed in 
    Sec. 53.62(d)(4).
        (3) Introduce particles into chamber. Introduce the particles into 
    the static chamber and allow the particle concentration to stabilize.
        (4) Install and operate the candidate sampler's fractionator and 
    its after-filter and at least four total filters. (i) Install the 
    fractionator and an array of four or more equally spaced total filter 
    samplers such that the total filters surround and are in the same plane 
    as the inlet of the fractionator.
        (ii) Simultaneously collect particles onto appropriate filters with 
    the total filter samplers and the fractionator for a time period such 
    that the relative error
    
    [[Page 38822]]
    
    of the measured concentration is less than 5.0 percent.
        (5) Calculate the aerosol spatial uniformity in the chamber. (i) 
    Determine the quantity of material collected with each total filter 
    sampler in the array using a calibrated fluorometer. Calculate and 
    record the mass concentration for each total filter sampler as:
    
    Equation 25
    [GRAPHIC] [TIFF OMITTED] TR18JY97.118
    
    where:
    i = replicate number;
    j = total filter sampler number;
    Mtotal = mass of material collected with the total filter 
    sampler;
    Q = total filter sampler volumetric flowrate; and
    t = sample time.
    
        (ii) Calculate and record the mean mass concentration as:
    
    Equation 26
    [GRAPHIC] [TIFF OMITTED] TR18JY97.119
    
    where:
    n = total number of samplers;
    i = replicate number; and
    j = filter sampler number.
    
        (iii) (A) Calculate and record the coefficient of variation of the 
    total mass concentration as:
    
    Equation 27
    [GRAPHIC] [TIFF OMITTED] TR18JY97.120
    
    where:
    i = replicate number;
    j = total filter sampler number; and
    n = number of total filter samplers.
    
        (B) If the value of CVtotal exceeds 10 percent, then the 
    particle concentration uniformity is unacceptable, alterations to the 
    static chamber test apparatus must be made, and steps in paragraphs 
    (f)(1) through (f)(5) of this section must be repeated.
        (6) Determine the effectiveness of the candidate sampler. (i) 
    Determine the quantity of material collected on the candidate sampler's 
    after filter using a calibrated fluorometer. Calculate and record the 
    mass concentration for the candidate sampler as:
    
    Equation 28
    [GRAPHIC] [TIFF OMITTED] TR18JY97.121
    
    where:
    i = replicate number;
    Mcand = mass of material collected with the candidate 
    sampler;
    Q = candidate sampler volumetric flowrate; and
    t = sample time.
    
        (ii) Calculate and record the sampling effectiveness of the 
    candidate sampler as:
    
    Equation 29
    [GRAPHIC] [TIFF OMITTED] TR18JY97.122
    
    where:
    i = replicate number.
    
        (iii) Repeat step in paragraph (f)(4) through (f)(6) of this 
    section, as appropriate, to obtain a minimum of three replicate 
    measurements of sampling effectiveness.
        (iv) Calculate and record the average sampling effectiveness of the 
    test sampler as:
    
    Equation 30
    [GRAPHIC] [TIFF OMITTED] TR18JY97.123
    
    where:
    i= replicate number.
    
        (v)(A) Calculate and record the coefficient of variation for the 
    replicate sampling effectiveness measurements of the test sampler as:
    
    Equation 31
    [GRAPHIC] [TIFF OMITTED] TR18JY97.124
    
    where:
    i = replicate number; and
    n = number of measurements of effectiveness.
    
        (B) If the value of CVE exceeds 10 percent, then the 
    test run (steps in paragraphs (f)(2) through (f)(6) of this section) is 
    unacceptable and must be repeated.
        (7) Repeat steps in paragraphs (f)(1) through (f)(6) of this 
    section for each particle size specified in Table F-2 of this subpart.
        (g) Test procedure: Divided flow method--(1) Generate calibration 
    aerosol. Follow the procedures for aerosol generation prescribed in 
    Sec. 53.62(d)(2).
        (2) Verify the quality of the calibration aerosol. Follow the 
    procedures for verification of calibration aerosol size and quality 
    prescribed in Sec. 53.62(d)(4).
        (3) Introduce aerosol. Introduce the calibration aerosol into the 
    static chamber and allow the particle concentration to stabilize.
        (4) Validate that transport is equal for the divided flow option. 
    (i) With fluorometry as a detector:
        (A) Install a total filter on each leg of the divided flow 
    apparatus.
        (B) Collect particles simultaneously through both legs at 16.7 L/
    min onto an appropriate filter for a time period such that the relative 
    error of the measured concentration is less than 5.0 percent.
        (C) Determine the quantity of material collected on each filter 
    using a calibrated fluorometer. Calculate and record the mass 
    concentration measured in each leg as:
    
    Equation 32
    [GRAPHIC] [TIFF OMITTED] TR18JY97.125
    
    where:
    i = replicate number,
    M = mass of material collected with the total filter; and
    Q = candidate sampler volumetric flowrate.
    
        (D) Repeat steps in paragraphs (g)(4)(i)(A) through (g)(4)(i)(C) of 
    this section until a minimum of three replicate measurements are 
    performed.
        (ii) With a number counting device such as an aerosol detector:
        (A) Remove all flow obstructions from the flow paths of the two 
    legs.
    
    [[Page 38823]]
    
        (B) Quantify the aerosol concentration of the primary particles in 
    each leg of the apparatus.
        (C) Repeat steps in paragraphs (g)(4)(ii)(A) through (g)(4)(ii)(B) 
    of this section until a minimum of three replicate measurements are 
    performed.
        (iii) (A) Calculate the mean concentration and coefficient of 
    variation as:
    
    Equation 33
    [GRAPHIC] [TIFF OMITTED] TR18JY97.126
    
    Equation 34
    [GRAPHIC] [TIFF OMITTED] TR18JY97.127
    
    where:
    i = replicate number; and
    n = number of replicates.
    
        (B) If the measured mean concentrations through the two legs do not 
    agree within 5 percent, then adjustments may be made in the setup, and 
    this step must be repeated.
        (5) Determine effectiveness. Determine the sampling effectiveness 
    of the test sampler with the inlet removed by one of the following 
    procedures:
        (i) With fluorometry as a detector:
        (A) Prepare the divided flow apparatus for particle collection. 
    Install a total filter into the bypass leg of the divided flow 
    apparatus. Install the particle size fractionator with a total filter 
    placed immediately downstream of it into the other leg.
        (B) Collect particles simultaneously through both legs at 16.7 L/
    min onto appropriate filters for a time period such that the relative 
    error of the measured concentration is less than 5.0 percent.
        (C) Determine the quantity of material collected on each filter 
    using a calibrated fluorometer. Calculate and record the mass 
    concentration measured by the total filter and that measured after 
    penetrating through the candidate fractionator as follows:
    
    Equation 35
    [GRAPHIC] [TIFF OMITTED] TR18JY97.128
    
    Equation 36
    [GRAPHIC] [TIFF OMITTED] TR18JY97.129
    
    where:
    i = replicate number.
    
        (ii) With a number counting device as a detector:
        (A) Install the particle size fractionator into one of the legs of 
    the divided flow apparatus.
        (B) Quantify and record the aerosol number concentration of the 
    primary particles passing through the fractionator as 
    Ccand(i).
        (C) Divert the flow from the leg containing the candidate 
    fractionator to the bypass leg. Allow sufficient time for the aerosol 
    concentration to stabilize.
        (D) Quantify and record the aerosol number concentration of the 
    primary particles passing through the bypass leg as 
    Ctotal(i).
        (iii) Calculate and record sampling effectiveness of the candidate 
    sampler as:
    
    Equation 37
    [GRAPHIC] [TIFF OMITTED] TR18JY97.130
    
    where:
    i = replicate number.
    
        (6) Repeat step in paragraph (g)(5) of this section, as 
    appropriate, to obtain a minimum of three replicate measurements of 
    sampling effectiveness.
        (7) Calculate the mean and coefficient of variation for replicate 
    measurements of effectiveness. (i) Calculate and record the mean 
    sampling effectiveness of the candidate sampler as:
    
    Equation 38
    [GRAPHIC] [TIFF OMITTED] TR18JY97.131
    
    where:
    i = replicate number.
    
        (ii)(A) Calculate and record the coefficient of variation for the 
    replicate sampling effectiveness measurements of the candidate sampler 
    as:
    
    Equation 39
    [GRAPHIC] [TIFF OMITTED] TR18JY97.132
    
    where:
    i = replicate number; and
    n = number of replicates.
    
        (B) If the coefficient of variation is not less than 10 percent, 
    then the test run must be repeated (steps in paragraphs (g)(1) through 
    (g)(7) of this section).
        (8) Repeat steps in paragraphs (g)(1) through (g)(7) of this 
    section for each particle size specified in Table F-2 of this subpart.
        (h) Calculations--(1) Treatment of multiplets. For all measurements 
    made by fluorometric analysis, data shall be corrected for the presence 
    of multiplets as described in Sec. 53.62(f)(1). Data collected using a 
    real-time device (as described in paragraph (c)(3)(ii)) of this section 
    will not require multiplet correction.
        (2) Cutpoint determination. For each wind speed determine the 
    sampler Dp50 cutpoint defined as the aerodynamic particle 
    size corresponding to 50 percent effectiveness from the multiplet 
    corrected smooth curve.
        (3) Graphical analysis and numerical integration with ambient 
    distributions. Follow the steps outlined in Sec. 53.62(e)(3) through 
    (e)(4) to calculate the estimated concentration measurement ratio 
    between the candidate sampler and a reference method sampler.
        (i) Test evaluation. The candidate method passes the static 
    fractionator test if the values of Rc and Dp50 for each 
    distribution meets the specifications in Table F-1 of this subpart.
    
    
    Sec. 53.65   Test procedure: Loading test.
    
        (a) Overview. (1) The loading tests are designed to quantify any 
    appreciable changes in a candidate method sampler's performance as a 
    function of coarse aerosol collection. The candidate sampler is exposed 
    to a mass of coarse aerosol equivalent to sampling a mass concentration 
    of 150 g/m3 over the time period that the 
    manufacturer has specified between periodic cleaning. After loading, 
    the candidate sampler is then evaluated by performing the test in 
    Sec. 53.62 (full wind tunnel test), Sec. 53.63 (wind tunnel inlet 
    aspiration test), or Sec. 53.64 (static fractionator test). If the 
    acceptance criteria are met for this evaluation test, then the 
    candidate sampler is approved for multi-day sampling with the periodic 
    maintenance schedule as specified by the candidate method. For example, 
    if the candidate sampler passes the reevaluation tests following 
    loading with an aerosol mass equivalent to sampling a 150 g/
    m3 aerosol continuously for 7 days, then the sampler is 
    approved for 7 day field operation before cleaning is required.
        (b) Technical definition. Effectiveness after loading is the ratio 
    (expressed as a percentage) of the mass concentration of particles of a 
    given size reaching the sampler filter to the mass concentration of 
    particles of the same size approaching the sampler.
        (c) Facilities and equipment required--(1) Particle delivery 
    system. The particle delivery system shall consist of a static chamber 
    or a low velocity wind tunnel having a
    
    [[Page 38824]]
    
    sufficiently large cross-sectional area such that the test sampler, or 
    portion thereof, may be installed in the test section. At a minimum, 
    the system must have a sufficiently large cross section to house the 
    candidate sampler inlet as well as a collocated isokinetic nozzle for 
    measuring total aerosol concentration. The mean velocity in the test 
    section of the static chamber or wind tunnel shall not exceed 2 km/hr.
        (2) Aerosol generation equipment. For purposes of these tests, the 
    test aerosol shall be produced from commercially available, bulk 
    Arizona road dust. To provide direct interlaboratory comparability of 
    sampler loading characteristics, the bulk dust is specified as 0-10 
    m ATD available from Powder Technology Incorporated 
    (Burnsville, MN). A fluidized bed aerosol generator, Wright dust 
    feeder, or sonic nozzle shall be used to efficiently deagglomerate the 
    bulk test dust and transform it into an aerosol cloud. Other dust 
    generators may be used contingent upon prior approval by the Agency.
        (3) Isokinetic sampler. Mean aerosol concentration within the 
    static chamber or wind tunnel shall be established using a single 
    isokinetic sampler containing a preweighed high-efficiency total 
    filter.
        (4) Analytic balance. An analytical balance shall be used to 
    determine the weight of the total filter in the isokinetic sampler. The 
    precision and accuracy of this device shall be such that the relative 
    measurement error is less than 5.0 percent for the difference between 
    the initial and final weight of the total filter. The identical 
    analytic balance shall be used to perform both initial and final 
    weighing of the total filter.
        (d) Test procedure. (1) Calculate and record the target time 
    weighted concentration of Arizona road dust which is equivalent to 
    exposing the sampler to an environment of 150 g/m3 
    over the time between cleaning specified by the candidate sampler's 
    operations manual as:
    
    Equation 40
    [GRAPHIC] [TIFF OMITTED] TR18JY97.133
    
    where:
    t = the number of hours specified by the candidate method prior to 
    periodic cleaning.
    
        (2) Clean the candidate sampler. (i) Clean and dry the internal 
    surfaces of the candidate sampler.
        (ii) Prepare the internal surfaces in strict accordance with the 
    operating manual referred to in section 7.4.18 of 40 CFR part 50, 
    Appendix L.
        (3) Determine the preweight of the filter that shall be used in the 
    isokinetic sampler. Record this value as InitWt.
        (4) Install the candidate sampler's inlet and the isokinetic 
    sampler within the test chamber or wind tunnel.
        (5) Generate a dust cloud. (i) Generate a dust cloud composed of 
    Arizona test dust.
        (ii) Introduce the dust cloud into the chamber.
        (iii) Allow sufficient time for the particle concentration to 
    become steady within the chamber.
        (6) Sample aerosol with a total filter and the candidate sampler. 
    (i) Sample the aerosol for a time sufficient to produce an equivalent 
    TWC equal to that of the target TWC  15 percent.
        (ii) Record the sampling time as t.
        (7) Determine the time weighted concentration. (i) Determine the 
    postweight of the isokinetic sampler's total filter.
        (ii) Record this value as FinalWt.
        (iii) Calculate and record the TWC as:
    
    Equation 41
    [GRAPHIC] [TIFF OMITTED] TR18JY97.134
    
    where:
    Q = the flow rate of the candidate method.
    
        (iv) If the value of TWC deviates from the target TWC  
    15 percent, then the loaded mass is unacceptable and the entire test 
    procedure must be repeated.
        (8) Determine the candidate sampler's effectiveness after loading. 
    The candidate sampler's effectiveness as a function of particle 
    aerodynamic diameter must then be evaluated by performing the test in 
    Sec. 53.62 (full wind tunnel test). A sampler which fits the category 
    of inlet deviation in Sec. 53.60(e)(1) may opt to perform the test in 
    Sec. 53.63 (inlet aspiration test) in lieu of the full wind tunnel 
    test. A sampler which fits the category of fractionator deviation in 
    Sec. 53.60(e)(2) may opt to perform the test in Sec. 53.64 (static 
    fractionator test) in lieu of the full wind tunnel test.
        (e) Test results. If the candidate sampler meets the acceptance 
    criteria for the evaluation test performed in paragraph (d)(8) of this 
    section, then the candidate sampler passes this test with the 
    stipulation that the sampling train be cleaned as directed by and as 
    frequently as that specified by the candidate sampler's operations 
    manual.
    
    
    Sec. 53.66   Test procedure: Volatility test.
    
        (a) Overview. This test is designed to ensure that the candidate 
    method's losses due to volatility when sampling semi-volatile ambient 
    aerosol will be comparable to that of a federal reference method 
    sampler. This is accomplished by challenging the candidate sampler with 
    a polydisperse, semi-volatile liquid aerosol in three distinct phases. 
    During phase A of this test, the aerosol is elevated to a steady-state, 
    test-specified mass concentration and the sample filters are 
    conditioned and preweighed. In phase B, the challenge aerosol is 
    simultaneously sampled by the candidate method sampler and a reference 
    method sampler onto the preweighed filters for a specified time period. 
    In phase C (the blow-off phase), aerosol and aerosol-vapor free air is 
    sampled by the samplers for an additional time period to partially 
    volatilize the aerosol on the filters. The candidate sampler passes the 
    volatility test if the acceptance criteria presented in Table F-1 of 
    this subpart are met or exceeded.
        (b) Technical definitions. (1) Residual mass (RM) is defined as the 
    weight of the filter after the blow-off phase subtracted from the 
    initial weight of the filter.
        (2) Corrected residual mass (CRM) is defined as the residual mass 
    of the filter from the candidate sampler multiplied by the ratio of the 
    reference method flow rate to the candidate method flow rate.
        (c) Facilities and equipment required--(1) Environmental chamber. 
    Because the nature of a volatile aerosol is greatly dependent upon 
    environmental conditions, all phases of this test shall be conducted at 
    a temperature of 22.0  0.5  deg.C and a relative humidity 
    of 40  3 percent. For this reason, it is strongly advised 
    that all weighing and experimental apparatus be housed in an 
    environmental chamber capable of this level of control.
        (2) Aerosol generator. The aerosol generator shall be a pressure 
    nebulizer operated at 20 to 30 psig (140 to 207 kPa) to produce a 
    polydisperse, semi-voltile aerosol with a mass median diameter larger 
    than 1 m and smaller than 2.5 m. The nebulized liquid 
    shall be A.C.S. reagent grade glycerol 
    (C3H8O, FW = 92.09, CAS 56-81-5) of 
    99.5 percent minimum purity. For the purpose of this test the accepted 
    mass median diameter is predicated on the stable aerosol inside the 
    internal chamber and not on the aerosol emerging from the nebulizer 
    nozzle. Aerosol monitoring and its stability are described in (c)(3) 
    and (c)(4) of this section.
        (3) Aerosol monitoring equipment. The evaporation and condensation 
    dynamics of a volatile aerosol is greatly dependent upon the vapor 
    pressure of the volatile component in the carrier gas. The size of an 
    aerosol becomes fixed only when an equilibrium is established between 
    the aerosol and the surrounding vapor; therefore, aerosol
    
    [[Page 38825]]
    
    size measurement shall be used as a surrogate measure of this 
    equilibrium. A suitable instrument with a range of 0.3 to 10 
    m, an accuracy of 0.5 m, and a resolution of 0.2 
    m (e.g., an optical particle sizer, or a time-of-flight 
    instrument) shall be used for this purpose. The parameter monitored for 
    stability shall be the mass median instrument measured diameter (i.e. 
    optical diameter if an optical particle counter is used). A stable 
    aerosol shall be defined as an aerosol with a mass median diameter that 
    has changed less than 0.25 m over a 4 hour time period.
        (4) Internal chamber. The time required to achieve a stable aerosol 
    depends upon the time during which the aerosol is resident with the 
    surrounding air. This is a function of the internal volume of the 
    aerosol transport system and may be facilitated by recirculating the 
    challenge aerosol. A chamber with a volume of 0.5 m3 and a 
    recirculating loop (airflow of approximately 500 cfm) is recommended 
    for this purpose. In addition, a baffle is recommended to dissipate the 
    jet of air that the recirculating loop can create. Furthermore, a HEPA 
    filtered hole in the wall of the chamber is suggested to allow makeup 
    air to enter the chamber or excess air to exit the chamber to maintain 
    a system flow balance. The concentration inside the chamber shall be 
    maintained at 1 mg/m3  20 percent to obtain 
    consistent and significant filter loading.
        (5) Aerosol sampling manifold. A manifold shall be used to extract 
    the aerosol from the area in which it is equilibrated and transport it 
    to the candidate method sampler, the reference method sampler, and the 
    aerosol monitor. The losses in each leg of the manifold shall be 
    equivalent such that the three devices will be exposed to an identical 
    aerosol.
        (6) Chamber air temperature recorders. Minimum range 15-25  deg.C, 
    certified accuracy to within 0.2  deg.C, resolution of 0.1  deg.C. 
    Measurement shall be made at the intake to the sampling manifold and 
    adjacent to the weighing location.
        (7) Chamber air relative humidity recorders. Minimum range 30 - 50 
    percent, certified accuracy to within 1 percent, resolution of 0.5 
    percent. Measurement shall be made at the intake to the sampling 
    manifold and adjacent to the weighing location.
        (8) Clean air generation system. A source of aerosol and aerosol-
    vapor free air is required for phase C of this test. This clean air 
    shall be produced by filtering air through an absolute (HEPA) filter.
        (9) Balance. Minimum range 0 - 200 mg, certified accuracy to within 
    10 g, resolution of 1 g.
        (d) Additional filter handling conditions. (1) Filter handling. 
    Careful handling of the filter during sampling, conditioning, and 
    weighing is necessary to avoid errors due to damaged filters or loss of 
    collected particles from the filters. All filters must be weighed 
    immediately after phase A dynamic conditioning and phase C.
        (2) Dynamic conditioning of filters. Total dynamic conditioning is 
    required prior to the initial weight determined in phase A. Dynamic 
    conditioning refers to pulling clean air from the clean air generation 
    system through the filters. Total dynamic conditioning can be 
    established by sequential filter weighing every 30 minutes following 
    repetitive dynamic conditioning. The filters are considered 
    sufficiently conditioned if the sequential weights are repeatable to 
     3 g.
        (3) Static charge. The following procedure is suggested for 
    minimizing charge effects. Place six or more Polonium static control 
    devices (PSCD) inside the microbalance weighing chamber, (MWC). Two of 
    them must be placed horizontally on the floor of the MWC and the 
    remainder placed vertically on the back wall of the MWC. Taping two 
    PSCD's together or using double-sided tape will help to keep them from 
    falling. Place the filter that is to be weighed on the horizontal PSCDs 
    facing aerosol coated surface up. Close the MWC and wait 1 minute. Open 
    the MWC and place the filter on the balance dish. Wait 1 minute. If the 
    charges have been neutralized the weight will stabilize within 30-60 
    seconds. Repeat the procedure of neutralizing charges and weighing as 
    prescribed above several times (typically 2-4 times) until consecutive 
    weights will differ by no more than 3 micrograms. Record the last 
    measured weight and use this value for all subsequent calculations.
        (e) Test procedure--(1) Phase A - Preliminary steps. (i) Generate a 
    polydisperse glycerol test aerosol.
        (ii) Introduce the aerosol into the transport system.
        (iii) Monitor the aerosol size and concentration until stability 
    and level have been achieved.
        (iv) Condition the candidate method sampler and reference method 
    sampler filters until total dynamic conditioning is achieved as 
    specified in paragraph (d)(2) of this section.
        (v) Record the dynamically conditioned weight as InitWtc 
    and InitWtr where c is the candidate method sampler and r is 
    the reference method sampler.
        (2) Phase B - Aerosol loading. (i) Install the dynamically 
    conditioned filters into the appropriate samplers.
        (ii) Attach the samplers to the manifold.
        (iii) Operate the candidate and the reference samplers such that 
    they simultaneously sample the test aerosol for 30 minutes.
        (3) Phase C - Blow-off. (i) Alter the intake of the samplers to 
    sample air from the clean air generation system.
        (ii) Sample clean air for one of the required blow-off time 
    durations (1, 2, 3, and 4 hours).
        (iii) Remove the filters from the samplers.
        (iv) Weigh the filters immediately and record this weight, 
    FinalWtc and FinalWtr, where c is the candidate 
    method sampler and r is the reference method sampler.
        (v) Calculate the residual mass for the reference method sampler:
    
    Equation 41a
    [GRAPHIC] [TIFF OMITTED] TR18JY97.135
    
    where:
    i = repetition number; and
    j = blow-off time period.
    
        (vi) Calculate the corrected residual mass for the candidate method 
    sampler as:
    
    Equation 41b
    [GRAPHIC] [TIFF OMITTED] TR18JY97.136
    
    where:
    i = repetition number;
    j = blow-off time period;
    Qc = candidate method sampler flow rate, and
    Qr = reference method sampler flow rate.
    
        (4) Repeat steps in paragraph (e)(1) through (e)(3) of this section 
    until three repetitions have been completed for each of the required 
    blow-off time durations (1, 2, 3, and 4 hours).
        (f) Calculations and analysis. (1) Perform a linear regression with 
    the candidate method CRM as the dependent variable and the reference 
    method RM as the independent variable.
        (2) Determine the following regression parameters: slope, 
    intercept, and correlation coefficient (r).
        (g) Test results. The candidate method passes the volatility test 
    if the regression parameters meet the acceptance criteria specified in 
    Table F-1 of this subpart.
    
    Tables to Subpart F of Part 53
    
    [[Page 38826]]
    
    
    
      Table F-1.--Performance Specifications for PM2.5 Class II Equivalent  
                                    Samplers                                
    ------------------------------------------------------------------------
                                                              Acceptance    
            Performance Test            Specifications         Criteria     
    ------------------------------------------------------------------------
    Sec.  53.62 Full Wind Tunnel     Solid VOAG produced  Dp50 = 2.5 m  
                                      and 24 km/hr.        0.2 m;  
                                                           Numerical        
                                                           Analysis Results:
                                                           95% Rc1
                                                           05%              
    Sec.  53.63 Wind Tunnel Inlet    Liquid VOAG          Relative          
     Aspiration Test.                 produced aerosol     Aspiration: 95%  
                                      at 2 km/hr and 24    A50 = 2.5 m  
                                      static conditions    0.2 m;  
                                                           Numerical        
                                                           Analysis Results:
                                                           95% Rc1
                                                           05%              
    Sec.  53.65 Loading Test.......  Loading of the       Acceptance        
                                      clean candidate      criteria as      
                                      under laboratory     specified in the 
                                      conditions           post-loading     
                                                           evaluation test  
                                                           (Sec.  53.62,    
                                                           Sec.  53.63, or  
                                                           Sec.  53.64)     
    Sec.  53.66 Volatility Test....  Polydisperse liquid  Regression        
                                      aerosol produced     Parameters Slope 
                                      by air               = 1  
                                      nebulization of      0.1, Intercept = 
                                      A.C.S. reagent       0    
                                      grade glycerol,      0.15 r  0.97     
                                      99.5% minimum                         
                                      purity                                
    ------------------------------------------------------------------------
    
    
      Table F-2.--Particle Sizes and Wind Speeds for Full Wind Tunnel Test, Wind Tunnel Inlet Aspiration Test, and  
                                                   Static Chamber Test                                              
    ----------------------------------------------------------------------------------------------------------------
                                             Full Wind Tunnel Test   Inlet Aspiration Test     Static               
     Primary Partical Mean Size a (m)                     2 km/hr    24 km/hr     2 km/hr    24 km/hr       Test         Test   
    ----------------------------------------------------------------------------------------------------------------
    1.50.25...................          S           S                                    S              
    2.00.25...................          S           S                                    S              
    2.20.25...................          S           S                                    S              
    2.50.25...................          S           S                                    S              
    2.80.25...................          S           S                                    S              
    3.00.25...................                                  L           L                           
    3.50.25...................          S           S                                    S              
    4.00.5....................          S           S                                    S              
    Polydisperse Glycerol Aerosol.........                                                                        L 
    ----------------------------------------------------------------------------------------------------------------
    a Aerodynamic diameter.                                                                                         
    S=Solid particles.                                                                                              
    L=Liquid particles.                                                                                             
    
    
                                        Table F-3.--Critical Parameters of Idealized Ambient Particle Size Distributions                                    
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Fine Particle Mode                    Coarse Particle Mode                      FRM Sampler
                                                      ------------------------------------------------------------------------------   PM2.5/     Expected  
                  Idealized Distribution                                            Conc.                                  Conc.        PM10     Mass Conc. 
                                                       MMD (g/  MMD (g/    Ratio    (g/
                                                           m>m)         Dev.         m3)          m>m)         Dev.         m3)                      m3)    
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Coarse...........................................         0.50           2         12.0            10           2         88.0        0.27       13.814 
    ``Typical''......................................         0.50           2         33.3            10           2         66.7        0.55       34.284 
    Fine.............................................         0.85           2         85.0            15           2         15.0        0.94       78.539 
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    
                          Table F-4.--Estimated Mass Concentration Measurement of PM2.5 for Idealized Coarse Aerosol Size Distribution                      
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Test Sampler                                                Ideal Sampler                      
                                     -----------------------------------------------------------------------------------------------------------------------
      Particle Aerodynamic Diameter                                             Estimated Mass                                              Estimated Mass  
              (m)                Fractional         Interval Mass       Concentration        Fractional         Interval Mass       Concentration  
                                           Sampling          Concentration        Measurement          Sampling          Concentration        Measurement   
                                         Effectiveness      (g/m3)     (g/m3)      Effectiveness      (g/m3)     (g/m3) 
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                   (1)                        (2)                 (3)                 (4)                 (5)                 (6)                 (7)       
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    <0.500 1.000="" 6.001="" 1.000="" 6.001="" 6.001="" 0.625="" 2.129="" 0.999="" 2.129="" 2.127="" 0.750="" 0.982="" 0.998="" 0.982="" 0.980="" 0.875="" 0.730="" 0.997="" 0.730="" 0.728="" 1.000="" 0.551="" 0.995="" 0.551="" 0.548="" 1.125="" 0.428="" 0.991="" 0.428="" 0.424="" 1.250="" 0.346="" 0.987="" 0.346="" 0.342="" 1.375="" 0.294="" 0.980="" 0.294="" 0.288="" 1.500="" 0.264="" 0.969="" 0.264="" 0.256="" 1.675="" 0.251="" 0.954="" 0.251="" 0.239="" 1.750="" 0.250="" 0.932="" 0.250="" 0.233="" 1.875="" 0.258="" 0.899="" 0.258="" 0.232="" [[page="" 38827]]="" 2.000="" 0.272="" 0.854="" 0.272="" 0.232="" 2.125="" 0.292="" 0.791="" 0.292="" 0.231="" 2.250="" 0.314="" 0.707="" 0.314="" 0.222="" 2.375="" 0.339="" 0.602="" 0.339="" 0.204="" 2.500="" 0.366="" 0.480="" 0.366="" 0.176="" 2.625="" 0.394="" 0.351="" 0.394="" 0.138="" 2.750="" 0.422="" 0.230="" 0.422="" 0.097="" 2.875="" 0.449="" 0.133="" 0.449="" 0.060="" 3.000="" 0.477="" 0.067="" 0.477="" 0.032="" 3.125="" 0.504="" 0.030="" 0.504="" 0.015="" 3.250="" 0.530="" 0.012="" 0.530="" 0.006="" 3.375="" 0.555="" 0.004="" 0.555="" 0.002="" 3.500="" 0.579="" 0.001="" 0.579="" 0.001="" 3.625="" 0.602="" 0.000000="" 0.602="" 0.000000="" 3.750="" 0.624="" 0.000000="" 0.624="" 0.000000="" 3.875="" 0.644="" 0.000000="" 0.644="" 0.000000="" 4.000="" 0.663="" 0.000000="" 0.663="" 0.000000="" 4.125="" 0.681="" 0.000000="" 0.681="" 0.000000="" 4.250="" 0.697="" 0.000000="" 0.697="" 0.000000="" 4.375="" 0.712="" 0.000000="" 0.712="" 0.000000="" 4.500="" 0.726="" 0.000000="" 0.726="" 0.000000="" 4.625="" 0.738="" 0.000000="" 0.738="" 0.000000="" 4.750="" 0.750="" 0.000000="" 0.750="" 0.000000="" 4.875="" 0.760="" 0.000000="" 0.760="" 0.000000="" 5.000="" 0.769="" 0.000000="" 0.769="" 0.000000="" 5.125="" 0.777="" 0.000000="" 0.777="" 0.000000="" 5.250="" 0.783="" 0.000000="" 0.783="" 0.000000="" 5.375="" 0.789="" 0.000000="" 0.789="" 0.000000="" 5.500="" 0.794="" 0.000000="" 0.794="" 0.000000="" 5.625="" 0.798="" 0.000000="" 0.798="" 0.000000="" 5.75="" 0.801="" 0.000000="" 0.801="" 0.000000="">sam(exp)=                                                  Cideal(exp)=        13.814            
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38828]]
    
    
                    Table F-5.--Estimated Mass Concentration Measurement of PM2.5 for Idealized ``Typical'' Coarse Aerosol Size Distribution                
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Test Sampler                                                Ideal Sampler                      
                                     -----------------------------------------------------------------------------------------------------------------------
      Particle Aerodynamic Diameter                                             Estimated Mass                                              Estimated Mass  
              (m)                Fractional         Interval Mass       Concentration        Fractional         Interval Mass       Concentration  
                                           Sampling          Concentration        Measurement          Sampling          Concentration        Measurement   
                                         Effectiveness      (g/m3)     (g/m3)      Effectiveness      (g/m3)     (g/m3) 
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                   (1)                        (2)                 (3)                 (4)                 (5)                 (6)                 (7)       
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    <0.500 1.000="" 16.651="" 1.000="" 16.651="" 16.651="" 0.625="" 5.899="" 0.999="" 5.899="" 5.893="" 0.750="" 2.708="" 0.998="" 2.708="" 2.703="" 0.875="" 1.996="" 0.997="" 1.996="" 1.990="" 1.000="" 1.478="" 0.995="" 1.478="" 1.471="" 1.125="" 1.108="" 0.991="" 1.108="" 1.098="" 1.250="" 0.846="" 0.987="" 0.846="" 0.835="" 1.375="" 0.661="" 0.980="" 0.661="" 0.648="" 1.500="" 0.532="" 0.969="" 0.532="" 0.516="" 1.675="" 0.444="" 0.954="" 0.444="" 0.424="" 1.750="" 0.384="" 0.932="" 0.384="" 0.358="" 1.875="" 0.347="" 0.899="" 0.347="" 0.312="" 2.000="" 0.325="" 0.854="" 0.325="" 0.277="" 2.125="" 0.314="" 0.791="" 0.314="" 0.248="" 2.250="" 0.312="" 0.707="" 0.312="" 0.221="" 2.375="" 0.316="" 0.602="" 0.316="" 0.190="" 2.500="" 0.325="" 0.480="" 0.325="" 0.156="" 2.625="" 0.336="" 0.351="" 0.336="" 0.118="" 2.750="" 0.350="" 0.230="" 0.350="" 0.081="" 2.875="" 0.366="" 0.133="" 0.366="" 0.049="" 3.000="" 0.382="" 0.067="" 0.382="" 0.026="" 3.125="" 0.399="" 0.030="" 0.399="" 0.012="" 3.250="" 0.416="" 0.012="" 0.416="" 0.005="" 3.375="" 0.432="" 0.004="" 0.432="" 0.002="" 3.500="" 0.449="" 0.001="" 0.449="" 0.000000="" 3.625="" 0.464="" 0.000000="" 0.464="" 0.000000="" 3.750="" 0.480="" 0.000000="" 0.480="" 0.000000="" 3.875="" 0.494="" 0.000000="" 0.494="" 0.000000="" 4.000="" 0.507="" 0.000000="" 0.507="" 0.000000="" 4.125="" 0.520="" 0.000000="" 0.520="" 0.000000="" 4.250="" 0.000000="" 0.532="" 0.000000="" 4.375="" 0.000000="" 0.543="" 0.000000="" 4.500="" 0.000000="" 0.553="" 0.000000="" 4.625="" 0.000000="" 0.562="" 0.000000="" 4.750="" 0.000000="" 0.570="" 0.000000="" 4.875="" 0.000000="" 0.577="" 0.000000="" 5.000="" 0.000000="" 0.584="" 0.000000="" 5.125="" 0.000000="" 0.590="" 0.000000="" 5.250="" 0.000000="" 0.595="" 0.000000="" 5.375="" 0.000000="" 0.599="" 0.000000="" 5.500="" 0.000000="" 0.603="" 0.000000="" 5.625="" 0.000000="" 0.605="" 0.000000="" 5.75="" 0.000000="" 0.608="" 0.000000="">sam(exp)=                                                  Cideal(exp)=        34.284            
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38829]]
    
    
                           Table F-6.--Estimated Mass Concentration Measurement of PM2.5 for Idealized Fine Aerosol Size Distribution                       
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Test Sampler                                                Ideal Sampler                      
                                     -----------------------------------------------------------------------------------------------------------------------
      Particle Aerodynamic Diameter                                             Estimated Mass                                              Estimated Mass  
              (m)                Fractional         Interval Mass       Concentration        Fractional         Interval Mass       Concentration  
                                           Sampling          Concentration        Measurement          Sampling          Concentration        Measurement   
                                         Effectiveness      (g/m3)     (g/m3)      Effectiveness      (g/m3)     (g/m3) 
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                   (1)                        (2)                 (3)                 (4)                 (5)                 (6)                 (7)       
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    <0.500 1.000="" 18.868="" 1.000="" 18.868="" 18.868="" 0.625="" 13.412="" 0.999="" 13.412="" 13.399="" 0.750="" 8.014="" 0.998="" 8.014="" 7.998="" 0.875="" 6.984="" 0.997="" 6.984="" 6.963="" 1.000="" 5.954="" 0.995="" 5.954="" 5.924="" 1.125="" 5.015="" 0.991="" 5.015="" 4.970="" 1.250="" 4.197="" 0.987="" 4.197="" 4.142="" 1.375="" 3.503="" 0.980="" 3.503="" 3.433="" 1.500="" 2.921="" 0.969="" 2.921="" 2.830="" 1.675="" 2.438="" 0.954="" 2.438="" 2.326="" 1.750="" 2.039="" 0.932="" 2.039="" 1.900="" 1.875="" 1.709="" 0.899="" 1.709="" 1.536="" 2.000="" 1.437="" 0.854="" 1.437="" 1.227="" 2.125="" 1.212="" 0.791="" 1.212="" 0.959="" 2.250="" 1.026="" 0.707="" 1.026="" 0.725="" 2.375="" 0.873="" 0.602="" 0.873="" 0.526="" 2.500="" 0.745="" 0.480="" 0.745="" 0.358="" 2.625="" 0.638="" 0.351="" 0.638="" 0.224="" 2.750="" 0.550="" 0.230="" 0.550="" 0.127="" 2.875="" 0.476="" 0.133="" 0.476="" 0.063="" 3.000="" 0.414="" 0.067="" 0.414="" 0.028="" 3.125="" 0.362="" 0.030="" 0.362="" 0.011="" 3.250="" 0.319="" 0.012="" 0.319="" 0.004="" 3.375="" 0.282="" 0.004="" 0.282="" 0.001="" 3.500="" 0.252="" 0.001="" 0.252="" 0.000000="" 3.625="" 0.226="" 0.000000="" 0.226="" 0.000000="" 3.750="" 0.204="" 0.000000="" 0.204="" 0.000000="" 3.875="" 0.185="" 0.000000="" 0.185="" 0.000000="" 4.000="" 0.170="" 0.000000="" 0.170="" 0.000000="" 4.125="" 0.157="" 0.000000="" 0.157="" 0.000000="" 4.250="" 0.146="" 0.000000="" 0.146="" 0.000000="" 4.375="" 0.136="" 0.000000="" 0.136="" 0.000000="" 4.500="" 0.129="" 0.000000="" 0.129="" 0.000000="" 4.625="" 0.122="" 0.000000="" 0.122="" 0.000000="" 4.750="" 0.117="" 0.000000="" 0.117="" 0.000000="" 4.875="" 0.112="" 0.000000="" 0.112="" 0.000000="" 5.000="" 0.108="" 0.000000="" 0.108="" 0.000000="" 5.125="" 0.105="" 0.000000="" 0.105="" 0.000000="" 5.250="" 0.102="" 0.000000="" 0.102="" 0.000000="" 5.375="" 0.100="" 0.000000="" 0.100="" 0.000000="" 5.500="" 0.098="" 0.000000="" 0.098="" 0.000000="" 5.625="" 0.097="" 0.000000="" 0.097="" 0.000000="" 5.75="" 0.096="" 0.000000="" 0.096="" 0.000000="">sam(exp)=                                                  Cideal(exp)=        78.539            
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    
    [[Page 38830]]
    
    Figures to Subpart F of Part 53
    
    
    Figure E-1.--Designation Testing Checklist
    
    DESIGNATION TESTING CHECKLIST FOR CLASS II
    
    ____________________      ____________________      
    ____________________
    Auditee                 Auditor signature                 Date
    
                                                                                                                    
    ----------------------------------------------------------------------------------------------------------------
           Compliance Status:    Y = Yes     N = No     NA = Not applicable/Not available                           
    ---------------------------------------------------------------------------------------------                   
                                  Verification                                Verified by Direct                    
    -------------------------------------------------------------------------   Observation of                      
                                                                                 Process or of       Verification   
                                                                                  Documented      Comments (Includes
                                                                                   Evidence:       documentation of 
                                                                                 Performance,      who, what, where,
                                                                                   Design or       when, why) (Doc. 
                    Y                          N                  NA           Application Spec.    #, Rev. #, Rev. 
                                                                               Corresponding to          Date)      
                                                                              Sections of 40 CFR                    
                                                                               Part 53, Subparts                    
                                                                                    E and F                         
    ----------------------------------------------------------------------------------------------------------------
                                                                              Subpart E:                            
                                                                               Performance                          
                                                                               Specification                        
                                                                               Tests                                
    ----------------------------------------------------------------------------------------------------------------
                                                                                Evaluation                          
                                                                               completed                            
                                                                               according to                         
                                                                               Subpart E Sec.                       
                                                                               53.50 to Sec.                        
                                                                               53.56                                
    ----------------------------------------------------------------------------------------------------------------
                                                                              Subpart E: Class I                    
                                                                               Sequential Tests                     
    ----------------------------------------------------------------------------------------------------------------
                                                                              Class II samplers                     
                                                                               that are also                        
                                                                               Class I                              
                                                                               (sequentialized)                     
                                                                               have passed the                      
                                                                               tests in Sec.                        
                                                                               53.57                                
    ----------------------------------------------------------------------------------------------------------------
                                                                              Subpart F:                            
                                                                               Performance Spec/                    
                                                                               Test                                 
    ----------------------------------------------------------------------------------------------------------------
                                                                              Evaluation of                         
                                                                               Physical                             
                                                                               Characteristics                      
                                                                               of Clean Sampler -                   
                                                                                One of these                        
                                                                               tests must be                        
                                                                               performed:                           
                                                                              Sec.  53.62 - Full                    
                                                                               Wind Tunnel                          
                                                                              Sec.  53.63 -                         
                                                                               Inlet Aspiration                     
                                                                              Sec.  53.64 -                         
                                                                               Static                               
                                                                               Fractionator                         
    ----------------------------------------------------------------------------------------------------------------
                                                                              Evaluation of                         
                                                                               Physical                             
                                                                               Characteristics                      
                                                                               of Loaded Sampler                    
                                                                                                                    
                                                                                                                    
    ----------------------------------------------------------------------------------------------------------------
                                                                                Evaluation of                       
                                                                               the Volatile                         
                                                                               Characteristics                      
                                                                               of the Class II                      
                                                                               Sampler Sec.                         
                                                                               53.66                                
    ----------------------------------------------------------------------------------------------------------------
    
    Appendix A to Subpart F of Part 53--References
    
        (1) Marple, V.A., K.L. Rubow, W. Turner, and J.D. Spangler, Low 
    Flow Rate Sharp Cut Impactors for Indoor Air Sampling: Design and 
    Calibration., JAPCA, 37: 1303-1307 (1987).
        (2) Vanderpool, R.W. and K.L. Rubow, Generation of Large, Solid 
    Calibration Aerosols, J. of Aer. Sci. and Tech., 9:65-69 (1988).
        (3) Society of Automotive Engineers Aerospace Material 
    Specification (SAE AMS) 2404C, Electroless Nickel Planting, SAE, 400 
    Commonwealth Drive, Warrendale PA-15096, Revised 7-1-84, pp. 1-6.
    
    PART 58--[AMENDED]
    
        2. In part 58:
        a. The authority citation for part 58 continues to read as follows:
    
        Authority: 42 U.S.C. 7410, 7601(a), 7613, 7619.
    
        b. Section 58.1 is amended by removing the existing alphabetic 
    paragraph designations, by alphabetizing the existing definitions, by 
    revising the definition Traceable and by adding in alphabetical order 
    the following definitions to read as follows:
    
    
    Sec. 58.1   Definitions.
    
        *    *    *    *    *
        Annual State air monitoring report is an annual report, prepared by 
    control agencies and submitted to EPA for approval, that consists of an 
    annual data summary report for all pollutants and a detailed report 
    describing any proposed changes to their air quality surveillance 
    network.
        *    *    *    *    *
        Community Monitoring Zone (CMZ) means an optional averaging area 
    with established, well defined boundaries, such as county or census 
    block, within a MPA that has relatively uniform concentrations of 
    annual PM2.5 as defined by Appendix D of this part. Two or 
    more core SLAMS and other monitors within a CMZ that meet certain 
    requirements as set forth in Appendix D of this part may be averaged 
    for making comparisons to the annual PM2.5 NAAQS.
        Consolidated Metropolitan Statistical Area (CMSA) means the most 
    recent area as designated by the U.S. Office of Management and Budget 
    and population figures from the Bureau of the Census. The Department of 
    Commerce provides that within metropolitan complexes of 1 million or 
    more population, separate component areas are defined if specific 
    criteria are met. Such areas are designated primary metropolitan 
    statistical areas (PMSAs; and any area containing PMSAs is designated 
    CMSA.
        Core PM2.5 SLAMS means community-oriented monitoring 
    sites representative of community-wide exposures that are the basic 
    component sites of the PM2.5 SLAMS regulatory network. Core 
    PM2.5 SLAMS include community-oriented
    
    [[Page 38831]]
    
    SLAMS monitors, and sites collocated at PAMS.
        *    *    *    *    *
        Correlated acceptable continuous (CAC) PM analyzer means an 
    optional fine particulate matter analyzer that can be used to 
    supplement a PM2.5 reference or equivalent sampler, in 
    accordance with the provisions of Sec. 58.13(f).
        *    *    *    *    *
        Equivalent method means a method of sampling and analyzing the 
    ambient air for an air pollutant that has been designated as an 
    equivalent method in accordance with part 53 of this chapter; it does 
    not include a method for which an equivalent method designation has 
    been canceled in accordance with Sec. 53.11 or Sec. 53.16 of this 
    chapter.
        *    *    *    *    *
        Metropolitan Statistical Area (MSA) means the most recent area as 
    designated by the U.S. Office of Management and Budget and population 
    figures from the U.S. Bureau of the Census. The Department of Commerce 
    defines a metropolitan area as one of a large population nucleus, 
    together with adjacent communities that have a high degree of economic 
    and social integration with that nucleus.
        *    *    *    *    *
        Monitoring Planning Area (MPA) means a contiguous geographic area 
    with established, well defined boundaries, such as a metropolitan 
    statistical area, county or State, having a common area that is used 
    for planning monitoring locations for PM2.5. MPAs may cross 
    State boundaries, such as the Philadelphia PA-NJ MSA, and be further 
    subdivided into community monitoring zones. MPAs are generally oriented 
    toward areas with populations greater than 200,000, but for 
    convenience, those portions of a State that are not associated with 
    MSAs can be considered as a single MPA. MPAs must be defined, where 
    applicable, in a State PM monitoring network description.
        *    *    *    *    *
        Particulate matter monitoring network description, required by 
    Sec. 58.20(f), means a detailed plan, prepared by control agencies and 
    submitted to EPA for approval, that describes their PM2.5 
    and PM10 air quality surveillance network.
        *    *    *    *    *
        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 40 CFR part 50, Appendix L, and designated 
    in accordance with part 53 of this chapter or by an equivalent method 
    designated in accordance with part 53 of this chapter.
        *    *    *    *    *
        Population-oriented monitoring (or sites) applies to residential 
    areas, commercial areas, recreational areas, industrial areas, and 
    other areas where a substantial number of people may spend a 
    significant fraction of their day.
        Primary Metropolitan Statistical Area (PMSA) is a separate 
    component of a consolidated metropolitan statistical area. For the 
    purposes of this part, PMSA is used interchangeably with MSA.
        *    *    *    *    *
        Reference method means a method of sampling and analyzing the 
    ambient air for an air pollutant that will be 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 Sec. 53.11 or Sec. 53.16 of this 
    chapter.
        *    *    *    *    *
        Special Purpose Monitor (SPM) is a generic term used for all 
    monitors other than SLAMS, NAMS, PAMS, and PSD monitors included in an 
    agency's monitoring network for monitors used in a special study whose 
    data are officially reported to EPA.
        *    *    *    *    *
        Traceable means that a local standard has been compared and 
    certified, either directly or via not more than one intermediate 
    standard, to a National Institute of Standards and Technology (NIST)-
    certified primary standard such as a NIST-Traceable Reference Material 
    (NTRM) or a NIST-certified Gas Manufacturer's Internal Standard (GMIS).
        *    *    *    *    *
        c. Section 58.13 is amended by revising paragraphs (b) and (d) and 
    adding new paragraphs (e) and (f) to read as follows:
    
    
    Sec. 58.13   Operating schedule.
    
        *    *    *    *    *
        (b) For manual methods (excluding PM10 samplers, 
    PM2.5 samplers, and PAMS VOC samplers), at least one 24-hour 
    sample must be obtained every sixth day except during periods or 
    seasons exempted by the Regional Administrator.
        *    *    *    *    *
        (d) For PM10 samplers--a 24-hour sample must be taken a 
    minimum of every third day.
        (e) For PM2.5 samplers, a 24-hour sample is required 
    everyday for certain core SLAMS, including certain PAMS, as described 
    in section 2.8.1.3 of Appendix D of this part, except during seasons or 
    periods of low PM2.5 as otherwise exempted by the Regional 
    Administrator. A waiver of the everyday sampling schedule for SLAMS may 
    be granted by the Regional Administrator or designee, and for NAMS by 
    the Administrator or designee, for 1 calendar year from the time a 
    PM2.5 sequential sampler (FRM or Class I equivalent) has 
    been approved by EPA. A 24-hour sample must be taken a minimum of every 
    third day for all other SLAMS, including NAMS, as described in section 
    2.8.1.3 of Appendix D of this part, except when exempted by the 
    Regional Administrator in accordance with forthcoming EPA guidance. 
    During periods for which exemptions to every third day or every day 
    sampling are allowed for core PM2.5 SLAMS, a minimum 
    frequency of one in 6-day sampling is still required. However, 
    alternative sampling frequencies are allowed for SLAMS sites that are 
    principally intended for comparisons to the 24-hour NAAQS. Such 
    modifications must be approved by the Regional Administrator.
        (f) Alternatives to everyday sampling at sites with correlated 
    acceptable continuous analyzers. (1) Certain PM2.5 core 
    SLAMS sites located in monitoring planning areas (as described in 
    section 2.8 of Appendix D of this part) are required to sample every 
    day with a reference or equivalent method operating in accordance with 
    part 53 of this chapter and section 2 of Appendix C of this part. 
    However, in accordance with the monitoring priority as defined in 
    paragraph (f)(2) of this section, established by the control agency and 
    approved by EPA, a core SLAMS monitor may operate with a reference or 
    equivalent method on a 1 in 3-day schedule and produce data that may be 
    compared to the NAAQS, provided that it is collocated with an 
    acceptable continuous fine particulate PM analyzer that is correlated 
    with the reference or equivalent method. If the alternative sampling 
    schedule is selected by the control agency and approved by EPA, the 
    alternative schedule shall be implemented on January 1 of the year in 
    which everyday sampling is required. The selection of correlated 
    acceptable continuous PM analyzers and procedures for correlation with 
    the intermittent reference or equivalent method shall be in accordance 
    with procedures approved by the Regional Administrator. Unless the 
    continuous fine particulate analyzer satisfies the requirements of 
    section 2 of Appendix C of this part, however, the data derived from 
    the correlated acceptable continuous monitor are not eligible for 
    direct comparisons to the NAAQS in accordance with part 50 of this 
    chapter.
    
    [[Page 38832]]
    
        (2) A Metropolitan Statistical Area (MSA) (or primary metropolitan 
    statistical area) with greater than 1 million population and high 
    concentrations of PM2.5 (greater than or equal to 80 percent 
    of the NAAQS) shall be a Priority 1 PM monitoring area. Other 
    monitoring planning areas may be designated as Priority 2 PM monitoring 
    areas.
        (3) Core SLAMS having a correlated acceptable continuous analyzer 
    collocated with a reference or equivalent method in a Priority 1 PM 
    monitoring area may operate on the 1 in 3 sampling frequency only after 
    reference or equivalent data are collected for at least 2 complete 
    years.
        (4) In all monitoring situations, with a correlated acceptable 
    continuous alternative, FRM samplers or filter-based equivalent 
    analyzers should preferably accompany the correlated acceptable 
    continuous monitor.
        d. Section 58.14 is revised to read as follows:
    
    
    Sec. 58.14   Special purpose monitors.
    
        (a) Except as specified in paragraph (b) of this section, any 
    ambient air quality monitoring station other than a SLAMS or PSD 
    station from which the State intends to use the data as part of a 
    demonstration of attainment or nonattainment or in computing a design 
    value for control purposes of the National Ambient Air Quality 
    Standards (NAAQS) must meet the requirements for SLAMS as described in 
    Sec. 58.22 and, after January 1, 1983, must also meet the requirements 
    for SLAMS described in Sec. 58.13 and Appendices A and E of this part.
        (b) Based on the need, in transitioning to a PM2.5 
    standard that newly addresses the ambient impacts of fine particles, to 
    encourage a sufficiently extensive geographical deployment of 
    PM2.5 monitors and thus hasten the development of an 
    adequate PM2.5 ambient air quality monitoring 
    infrastructure, PM2.5 NAAQS violation determinations shall 
    not be exclusively made based on data produced at a population-oriented 
    SPM site during the first 2 complete calendar years of its operation. 
    However, a notice of NAAQS violations resulting from population-
    oriented SPMs shall be reported to EPA in the State's annual monitoring 
    report and be considered by the State in the design of its overall 
    SLAMS network; these population-oriented SPMs should be considered to 
    become a permanent SLAMS during the annual network review in accordance 
    with Sec. 58.25.
        (c) Any ambient air quality monitoring station other than a SLAMS 
    or PSD station from which the State intends to use the data for SIP-
    related functions other than as described in paragraph (a) of this 
    section is not necessarily required to comply with the requirements for 
    a SLAMS station under paragraph (a) of this section but must be 
    operated in accordance with a monitoring schedule, methodology, quality 
    assurance procedures, and probe or instrument-siting specifications 
    approved by the Regional Administrator.
        e. Section 58.20 is amended by revising the section heading, 
    paragraph (d), and the introductory text of paragraph (e), by 
    designating the flush text at the end of the section as paragraph (i) 
    and amending the third sentence by removing the words ``(a) through 
    (f)'' and adding in their place, ``(a) through (h)'', by redesignating 
    paragraph (f) as paragraph (h), and adding new paragraphs (f) and (g) 
    to read as follows:
    
    
    Sec. 58.20   Air quality surveillance: plan content.
    
        *    *    *    *    *
        (d) Provide for the review of the air quality surveillance system 
    on an annual basis to determine if the system meets the monitoring 
    objectives defined in Appendix D of this part. Such review must 
    identify needed modifications to the network such as termination or 
    relocation of unnecessary stations or establishment of new stations 
    that are necessary. For PM2.5, the review must identify 
    needed changes to core SLAMS, monitoring planning areas, the chosen 
    community monitoring approach including optional community monitoring 
    zones, SLAMS, or SPMs.
        (e) Provide for having a SLAMS network description available for 
    public inspection and submission to the Administrator upon request. The 
    network description must be available at the time of plan revision 
    submittal and must contain the following information for each SLAMS:
        *    *    *    *    *
        (f) Provide for having a PM monitoring network description 
    available for public inspection which must provide for monitoring 
    planning areas, and the community monitoring approach involving core 
    monitors and optional community monitoring zones for PM2.5. 
    The PM monitoring network description for PM10 and 
    PM2.5 must be submitted to the Regional Administrator for 
    approval by July 1, 1998, and must contain the following information 
    for each PM SLAMS and PM2.5 SPM:
        (1) The AIRS site identification form for existing stations.
        (2) The proposed location for scheduled stations.
        (3) The sampling and analysis method.
        (4) The operating schedule.
        (5) The monitoring objective, spatial scale of representativeness, 
    and additionally for PM2.5, the monitoring planning area, 
    optional community monitoring zone, and the site code designation to 
    identify which site will be identified as core SLAMS; and SLAMS or 
    population-oriented SPMs, if any, that are microscale or middle scale 
    in their representativeness as defined in Appendix D of this part.
        (6) A schedule for:
        (i) Locating, placing into operation, and making available the AIRS 
    site identification form for each SLAMS which is not located and 
    operating at the time of plan revision submittal.
        (ii) Implementing quality assurance procedures of Appendix A of 
    this part for each SLAMS for which such procedures are not implemented 
    at the time of plan revision submittal.
        (iii) Resiting each SLAMS which does not meet the requirements of 
    Appendix E of this part at the time of plan revision submittal.
        (g) Provide for having a list of all PM2.5 monitoring 
    locations including SLAMS, NAMS, PAMS and population-oriented SPMs, 
    that are included in the State's PM monitoring network description and 
    are intended for comparison to the NAAQS, available for public 
    inspection.
        *    *    *    *    *
        f. Section 58.23 is amended by revising the introductory text and 
    adding a new paragraph (c) to read as follows:
    
    
    Sec. 58.23   Monitoring network completion.
    
        With the exception of the PM10 monitoring networks that 
    shall be in place by March 16, 1998 and with the exception of the 
    PM2.5 monitoring networks as described in paragraph (c) of 
    this section:
        *    *    *    *    *
        (c) Each PM2.5 station in the SLAMS network must be in 
    operation in accordance with the minimum requirements of Appendix D of 
    this part, be sited in accordance with the criteria in Appendix E of 
    this part, and be located as described on the station's AIRS site 
    identification form, according to the following schedule:
        (1) Within 1 year after September 16, 1997, at least one required 
    core PM2.5 SLAMS site in each MSA with population greater 
    than 500,000, plus one site in each PAMS area, (plus at least two 
    additional SLAMS sites per State) must be in operation.
        (2) Within 2 years after September 16, 1997, all other required 
    SLAMS,
    
    [[Page 38833]]
    
    including all required core SLAMS, required regional background and 
    regional transport SLAMS, continuous PM monitors in areas with greater 
    than 1 million population, and all additional required PM2.5 
    SLAMS must be in operation.
        (3) Within 3 years after September 16, 1997, all additional sites 
    (e.g., sites classified as SLAMS/SPM to complete the mature network) 
    must be in operation.
        g. Section 58.26 is amended by revising the section heading and the 
    introductory text of paragraph (b), and adding paragraphs (d) and (e) 
    to read as follows:
    
    
    Sec. 58.26   Annual state air monitoring report.
    
        *    *    *    *    *
        (b) The SLAMS annual data summary report must contain:
        *    *    *    *    *
        (d) For PM monitoring and data--(1) The State shall submit a 
    summary to the appropriate Regional Office (for SLAMS) or Administrator 
    (through the Regional Office) (for NAMS) that details proposed changes 
    to the PM Monitoring Network Description and to be in accordance with 
    the annual network review requirements in Sec. 58.25. This shall 
    discuss the existing PM networks, including modifications to the 
    number, size or boundaries of monitoring planning areas and optional 
    community monitoring zones; number and location of PM10 and 
    PM2.5 SLAMS; number and location of core PM2.5 
    SLAMS; alternative sampling frequencies proposed for PM2.5 
    SLAMS (including core PM2.5 SLAMS and PM2.5 
    NAMS), core PM2.5 SLAMS to be designated PM2.5 
    NAMS; and PM10 and PM2.5 SLAMS to be designated 
    PM10 and PM2.5 NAMS respectively.
        (2) The State shall submit an annual summary to the appropriate 
    Regional Office of all the ambient air quality monitoring PM data from 
    all special purpose monitors that are described in the State's PM 
    monitoring network description and are intended for SIP purposes. These 
    include those population-oriented SPMs that are eligible for comparison 
    to the PM NAAQS. The State shall certify the data in accordance with 
    paragraph (c) of this section.
        (e) The Annual State Air Monitoring Report shall be submitted to 
    the Regional Administrator by July 1 or by an alternative annual date 
    to be negotiated between the State and Regional Administrator. The 
    Region shall provide review and approval/disapproval within 60 days. 
    After 3 years following September 16, 1997, the schedule for submitting 
    the required annual revised PM2.5 monitoring network 
    description may be altered based on a new schedule determined by the 
    Regional Administrator. States may submit an alternative PM monitoring 
    network description in which it requests exemptions from specific 
    required elements of the network design (e.g., required number of core 
    sites, other SLAMS, sampling frequency, etc.). After 3 years following 
    September 16, 1997 or once a CMZ monitoring area has been determined to 
    violate the NAAQS, then changes to an MPA monitoring network affecting 
    the violating locations shall require public review and notification.
        h. Section 58.30 is amended by revising the introductory text of 
    paragraph (a) to read as follows:
    
    
    Sec. 58.30   NAMS network establishment.
    
        (a) By January 1, 1980, with the exception of PM10 and 
    PM2.5 samplers, which shall be by July 1, 1998, the State 
    shall:
        *    *    *    *    *
        i. In Sec. 58.31, paragraph (f) is revised to read as follows:
    
    
    Sec. 58.31   NAMS network description.
    
        *    *    *    *    *
        (f) The monitoring objective, spatial scale of representativeness, 
    and for PM2.5, the monitoring planning area and community 
    monitoring zone, as defined in Appendix D of this part.
        *    *    *    *    *
        j. In Sec. 58.34, the introductory text is revised to read as 
    follows:
    
    
    Sec. 58.34   NAMS network completion.
    
        With the exception of PM10 samplers, which shall be by 1 
    year after September 16, 1997, and PM2.5, which shall be by 
    3 years after September 16, 1997:
        *    *    *    *    *
        k. In Sec. 58.35, the first sentence of paragraph (b) is revised to 
    read as follows:
    
    
    Sec. 58.35   NAMS data submittal.
    
        *    *    *    *    *
        (b) The State shall report to the Administrator all ambient air 
    quality data for SO2, CO, O3, NO2, Pb, 
    PM10, and PM2.5, and information specified by the 
    AIRS Users Guide (Volume II, Air Quality Data Coding, and Volume III, 
    Air Quality Data Storage) to be coded into the AIRS-AQS format. *  *  *
        *    *    *    *    *
        l. Revise Appendix A of part 58 to read as follows:
    Appendix A--Quality Assurance Requirements for State and Local Air 
    Monitoring Stations (SLAMS)
    1. General Information.
        1.1 This Appendix specifies the minimum quality assurance/
    quality control (QA/QC) requirements applicable to SLAMS air 
    monitoring data submitted to EPA. State and local agencies are 
    encouraged to develop and maintain quality assurance programs more 
    extensive than the required minimum.
        1.2 To assure the quality of data from air monitoring 
    measurements, two distinct and important interrelated functions must 
    be performed. One function is the control of the measurement process 
    through broad quality assurance activities, such as establishing 
    policies and procedures, developing data quality objectives, 
    assigning roles and responsibilities, conducting oversight and 
    reviews, and implementing corrective actions. The other function is 
    the control of the measurement process through the implementation of 
    specific quality control procedures, such as audits, calibrations, 
    checks, replicates, routine self-assessments, etc. In general, the 
    greater the control of a given monitoring system, the better will be 
    the resulting quality of the monitoring data. The results of quality 
    assurance reviews and assessments indicate whether the control 
    efforts are adequate or need to be improved.
        1.3 Documentation of all quality assurance and quality control 
    efforts implemented during the data collection, analysis, and 
    reporting phases is important to data users, who can then consider 
    the impact of these control efforts on the data quality (see 
    Reference 1 of this Appendix). Both qualitative and quantitative 
    assessments of the effectiveness of these control efforts should 
    identify those areas most likely to impact the data quality and to 
    what extent.
        1.4 Periodic assessments of SLAMS data quality are required to 
    be reported to EPA. To provide national uniformity in this 
    assessment and reporting of data quality for all SLAMS networks, 
    specific assessment and reporting procedures are prescribed in 
    detail in sections 3, 4, and 5 of this Appendix. On the other hand, 
    the selection and extent of the QA and QC activities used by a 
    monitoring agency depend on a number of local factors such as the 
    field and laboratory conditions, the objectives for monitoring, the 
    level of the data quality needed, the expertise of assigned 
    personnel, the cost of control procedures, pollutant concentration 
    levels, etc. Therefore, the quality system requirements, in section 
    2 of this Appendix, are specified in general terms to allow each 
    State to develop a quality assurance program that is most efficient 
    and effective for its own circumstances while achieving the Ambient 
    Air Quality Programs data quality objectives.
    2. Quality System Requirements.
        2.1 Each State and local agency must develop a quality system 
    (Reference 2 of this Appendix) to ensure that the monitoring 
    results:
        (a) Meet a well-defined need, use, or purpose.
        (b) Satisfy customers' expectations.
        (c) Comply with applicable standards specifications.
        (d) Comply with statutory (and other) requirements of society.
        (e) Reflect consideration of cost and economics.
        (f) Implement a quality assurance program consisting of 
    policies, procedures, specifications, standards, and documentation 
    necessary to:
    
    [[Page 38834]]
    
        (1) Provide data of adequate quality to meet monitoring 
    objectives, and
        (2) Minimize loss of air quality data due to malfunctions or 
    out-of-control conditions. This quality assurance program must be 
    described in detail, suitably documented in accordance with Agency 
    requirements (Reference 4 of this Appendix), and approved by the 
    appropriate Regional Administrator, or the Regional Administrator's 
    designee. The Quality Assurance Program will be reviewed during the 
    systems audits described in section 2.5 of this Appendix.
        2.2 Primary requirements and guidance documents for developing 
    the quality assurance program are contained in References 2 through 
    7 of this Appendix, which also contain many suggested and required 
    procedures, checks, and control specifications. Reference 7 of this 
    Appendix describes specific guidance for the development of a QA 
    Program for SLAMS. Many specific quality control checks and 
    specifications for methods are included in the respective reference 
    methods described in part 50 of this chapter or in the respective 
    equivalent method descriptions available from EPA (Reference 8 of 
    this Appendix). Similarly, quality control procedures related to 
    specifically designated reference and equivalent method analyzers 
    are contained in the respective operation or instruction manuals 
    associated with those analyzers. Quality assurance guidance for 
    meteorological systems at PAMS is contained in Reference 9 of this 
    Appendix. Quality assurance procedures for VOC, NOx 
    (including NO and NO2), O3, and carbonyl 
    measurements at PAMS must be consistent with Reference 15 of this 
    Appendix. Reference 4 of this Appendix includes requirements for the 
    development of quality assurance project plans, and quality 
    assurance and control programs, and systems audits demonstrating 
    attainment of the requirements.
        2.3 Pollutant Concentration and Flow Rate Standards.
        2.3.1 Gaseous pollutant concentration standards (permeation 
    devices or cylinders of compressed gas) used to obtain test 
    concentrations for CO, SO2, NO, and NO2 must 
    be traceable to either a National Institute of Standards and 
    Technology (NIST) NIST-Traceable Reference Material (NTRM) or a 
    NIST-certified Gas Manufacturer's Internal Standard (GMIS), 
    certified in accordance with one of the procedures given in 
    Reference 10 of this Appendix.
        2.3.2 Test concentrations for O3 must be obtained in 
    accordance with the UV photometric calibration procedure specified 
    in 40 CFR part 50, Appendix D, or by means of a certified ozone 
    transfer standard. Consult References 11 and 12 of this Appendix for 
    guidance on primary and transfer standards for O3.
        2.3.3 Flow rate measurements must be made by a flow measuring 
    instrument that is traceable to an authoritative volume or other 
    applicable standard. Guidance for certifying some types of 
    flowmeters is provided in Reference 7 of this Appendix.
        2.4 National Performance Audit Program (NPAP). Agencies 
    operating SLAMS are required to participate in EPA's NPAP. These 
    audits are described in Reference 7 of this Appendix. For further 
    instructions, agencies should contact either the appropriate EPA 
    Regional QA Coordinator at the appropriate EPA Regional Office 
    location, or the NPAP Coordinator, Emissions Monitoring and Analysis 
    Division (MD-14), U.S. Environmental Protection Agency, Research 
    Triangle Park, NC 27711.
        2.5 Systems Audit Programs. Systems audits of the ambient air 
    monitoring programs of agencies operating SLAMS shall be conducted 
    at least every 3 years by the appropriate EPA Regional Office. 
    Systems audit programs are described in Reference 7 of this 
    Appendix. For further instructions, agencies should contact either 
    the appropriate EPA Regional QA Coordinator or the Systems Audit QA 
    Coordinator, Office of Air Quality Planning and Standards, Emissions 
    Monitoring and Analysis Division (MD-14), U.S. Environmental 
    Protection Agency, Research Triangle Park, NC 27711.
    3. Data Quality Assessment Requirements.
        3.0.1 All ambient monitoring methods or analyzers used in SLAMS 
    shall be tested periodically, as described in this section, to 
    quantitatively assess the quality of the SLAMS data. Measurement 
    uncertainty is estimated for both automated and manual methods. 
    Terminology associated with measurement uncertainty are found within 
    this Appendix and includes:
        (a) Precision. A measurement of mutual agreement among 
    individual measurements of the same property usually under 
    prescribed similar conditions, expressed generally in terms of the 
    standard deviation;
        (b) Accuracy. The degree of agreement between an observed value 
    and an accepted reference value, accuracy includes a combination of 
    random error (precision) and systematic error (bias) components 
    which are due to sampling and analytical operations;
        (c) Bias. The systematic or persistent distortion of a 
    measurement process which causes errors in one direction. The 
    individual results of these tests for each method or analyzer shall 
    be reported to EPA as specified in section 4 of this Appendix. EPA 
    will then calculate quarterly assessments of measurement uncertainty 
    applicable to the SLAMS data as described in section 5 of this 
    Appendix. Data assessment results should be reported to EPA only for 
    methods and analyzers approved for use in SLAMS monitoring under 
    Appendix C of this part.
        3.0.2 Estimates of the data quality will be calculated on the 
    basis of single monitors and reporting organizations and may also be 
    calculated for each region and for the entire Nation. A reporting 
    organization is defined as a State, subordinate organization within 
    a State, or other organization that is responsible for a set of 
    stations that monitors the same pollutant and for which data quality 
    assessments can be pooled. States must define one or more reporting 
    organizations for each pollutant such that each monitoring station 
    in the State SLAMS network is included in one, and only one, 
    reporting organization.
        3.0.3 Each reporting organization shall be defined such that 
    measurement uncertainty among all stations in the organization can 
    be expected to be reasonably homogeneous, as a result of common 
    factors.
        (a) Common factors that should be considered by States in 
    defining reporting organizations include:
        (1) Operation by a common team of field operators.
        (2) Common calibration facilities.
        (3) Oversight by a common quality assurance organization.
        (4) Support by a common laboratory or headquarters.
        (b) Where there is uncertainty in defining the reporting 
    organizations or in assigning specific sites to reporting 
    organizations, States shall consult with the appropriate EPA 
    Regional Office. All definitions of reporting organizations shall be 
    subject to final approval by the appropriate EPA Regional Office.
        3.0.4 Assessment results shall be reported as specified in 
    section 4 of this Appendix. Table A-1 of this Appendix provides a 
    summary of the minimum data quality assessment requirements, which 
    are described in more detail in the following sections.
        3.1 Precision of Automated Methods Excluding PM2.5.
        3.1.1 Methods for SO2, NO2, O3 
    and CO. A one- point precision check must be performed at least once 
    every 2 weeks on each automated analyzer used to measure 
    SO2, NO2, O3 and CO. The precision 
    check is made by challenging the analyzer with a precision check gas 
    of known concentration (effective concentration for open path 
    analyzers) between 0.08 and 0.10 ppm for SO2, 
    NO2, and O3 analyzers, and between 8 and 10 
    ppm for CO analyzers. To check the precision of SLAMS analyzers 
    operating on ranges higher than 0 to 1.0 ppm SO2, 
    NO2, and O3, or 0 to 100 ppm for CO, use 
    precision check gases of appropriately higher concentration as 
    approved by the appropriate Regional Administrator or their 
    designee. However, the results of precision checks at concentration 
    levels other than those specified above need not be reported to EPA. 
    The standards from which precision check test concentrations are 
    obtained must meet the specifications of section 2.3 of this 
    Appendix.
        3.1.1.1 Except for certain CO analyzers described below, point 
    analyzers must operate in their normal sampling mode during the 
    precision check, and the test atmosphere must pass through all 
    filters, scrubbers, conditioners and other components used during 
    normal ambient sampling and as much of the ambient air inlet system 
    as is practicable. If permitted by the associated operation or 
    instruction manual, a CO point analyzer may be temporarily modified 
    during the precision check to reduce vent or purge flows, or the 
    test atmosphere may enter the analyzer at a point other than the 
    normal sample inlet, provided that the analyzer's response is not 
    likely to be altered by these deviations from the normal operational 
    mode. If a precision check is made in conjunction with a zero or 
    span adjustment, it must be made prior to such zero or span 
    adjustments. Randomization of the precision check with respect to 
    time of day, day of week, and routine service and adjustments is 
    encouraged where possible.
    
    [[Page 38835]]
    
        3.1.1.2 Open path analyzers are tested by inserting a test cell 
    containing a precision check gas concentration into the optical 
    measurement beam of the instrument. If possible, the normally used 
    transmitter, receiver, and as appropriate, reflecting devices should 
    be used during the test, and the normal monitoring configuration of 
    the instrument should be altered as little as possible to 
    accommodate the test cell for the test. However, if permitted by the 
    associated operation or instruction manual, an alternate local light 
    source or an alternate optical path that does not include the normal 
    atmospheric monitoring path may be used. The actual concentration of 
    the precision check gas in the test cell must be selected to produce 
    an effective concentration in the range specified in section 3.1.1. 
    Generally, the precision test concentration measurement will be the 
    sum of the atmospheric pollutant concentration and the precision 
    test concentration. If so, the result must be corrected to remove 
    the atmospheric concentration contribution. The corrected 
    concentration is obtained by subtracting the average of the 
    atmospheric concentrations measured by the open path instrument 
    under test immediately before and immediately after the precision 
    check test from the precision test concentration measurement. If the 
    difference between these before and after measurements is greater 
    than 20 percent of the effective concentration of the test gas, 
    discard the test result and repeat the test. If possible, open path 
    analyzers should be tested during periods when the atmospheric 
    pollutant concentrations are relatively low and steady.
        3.1.1.3 Report the actual concentration (effective concentration 
    for open path analyzers) of the precision check gas and the 
    corresponding concentration measurement (corrected concentration, if 
    applicable, for open path analyzers) indicated by the analyzer. The 
    percent differences between these concentrations are used to assess 
    the precision of the monitoring data as described in section 5.1. of 
    this Appendix.
        3.1.2 Methods for Particulate Matter Excluding PM2.5. 
    A one-point precision check must be performed at least once every 2 
    weeks on each automated analyzer used to measure PM10. 
    The precision check is made by checking the operational flow rate of 
    the analyzer. If a precision flow rate check is made in conjunction 
    with a flow rate adjustment, it must be made prior to such flow rate 
    adjustment. Randomization of the precision check with respect to 
    time of day, day of week, and routine service and adjustments is 
    encouraged where possible.
        3.1.2.1 Standard procedure: Use a flow rate transfer standard 
    certified in accordance with section 2.3.3 of this Appendix to check 
    the analyzer's normal flow rate. Care should be used in selecting 
    and using the flow rate measurement device such that it does not 
    alter the normal operating flow rate of the analyzer. Report the 
    actual analyzer flow rate measured by the transfer standard and the 
    corresponding flow rate measured, indicated, or assumed by the 
    analyzer.
        3.1.2.2 Alternative procedure:
        3.1.2.2.1 It is permissible to obtain the precision check flow 
    rate data from the analyzer's internal flow meter without the use of 
    an external flow rate transfer standard, provided that:
        3.1.2.2.1.1 The flow meter is audited with an external flow rate 
    transfer standard at least every 6 months.
        3.1.2.2.1.2 Records of at least the three most recent flow 
    audits of the instrument's internal flow meter over at least several 
    weeks confirm that the flow meter is stable, verifiable and accurate 
    to 4%.
        3.1.2.2.1.3 The instrument and flow meter give no indication of 
    improper operation.
        3.1.2.2.2 With suitable communication capability, the precision 
    check may thus be carried out remotely. For this procedure, report 
    the set-point flow rate as the actual flow rate along with the flow 
    rate measured or indicated by the analyzer flow meter.
        3.1.2.2.3 For either procedure, the percent differences between 
    the actual and indicated flow rates are used to assess the precision 
    of the monitoring data as described in section 5.1 of this Appendix 
    (using flow rates in lieu of concentrations). The percent 
    differences between these concentrations are used to assess the 
    precision of the monitoring data as described in section 5.1. of 
    this Appendix.
        3.2 Accuracy of Automated Methods Excluding PM2.5.
        3.2.1 Methods for SO2, NO2, O3, 
    or CO.
        3.2.1.1 Each calendar quarter (during which analyzers are 
    operated), audit at least 25 percent of the SLAMS analyzers that 
    monitor for SO2, NO2, O3, or CO 
    such that each analyzer is audited at least once per year. If there 
    are fewer than four analyzers for a pollutant within a reporting 
    organization, randomly reaudit one or more analyzers so that at 
    least one analyzer for that pollutant is audited each calendar 
    quarter. Where possible, EPA strongly encourages more frequent 
    auditing, up to an audit frequency of once per quarter for each 
    SLAMS analyzer.
        3.2.1.2 (a) The audit is made by challenging the analyzer with 
    at least one audit gas of known concentration (effective 
    concentration for open path analyzers) from each of the following 
    ranges applicable to the analyzer being audited:
    
    ------------------------------------------------------------------------
                                              Concentration Range, PPM      
                Audit Level           --------------------------------------
                                         SO2, O3        NO2           CO    
    ------------------------------------------------------------------------
    1................................    0.03-0.08    0.03-0.08          3-8
    2................................    0.15-0.20    0.15-0.20        15-20
    3................................    0.35-0.45    0.35-0.45        35-45
    4................................    0.80-0.90  ...........        80-90
    ------------------------------------------------------------------------
    
        (b) NO2 audit gas for chemiluminescence-type 
    NO2 analyzers must also contain at least 0.08 ppm NO.
        3.2.1.3 NO concentrations substantially higher than 0.08 ppm, as 
    may occur when using some gas phase titration (GPT) techniques, may 
    lead to audit errors in chemiluminescence analyzers due to 
    inevitable minor NO-NOx channel imbalance. Such errors 
    may be atypical of routine monitoring errors to the extent that such 
    NO concentrations exceed typical ambient NO concentrations at the 
    site. These errors may be minimized by modifying the GPT technique 
    to lower the NO concentrations remaining in the NO2 audit 
    gas to levels closer to typical ambient NO concentrations at the 
    site.
        3.2.1.4 To audit SLAMS analyzers operating on ranges higher than 
    0 to 1.0 ppm for SO2, NO2, and O3 
    or 0 to 100 ppm for CO, use audit gases of appropriately higher 
    concentration as approved by the appropriate Regional Administrator 
    or the Administrators's designee. The results of audits at 
    concentration levels other than those shown in the above table need 
    not be reported to EPA.
        3.2.1.5 The standards from which audit gas test concentrations 
    are obtained must meet the specifications of section 2.3 of this 
    Appendix. The gas standards and equipment used for auditing must not 
    be the same as the standards and equipment used for calibration or 
    calibration span adjustments. The auditor should not be the operator 
    or analyst who conducts the routine monitoring, calibration, and 
    analysis.
        3.2.1.6 For point analyzers, the audit shall be carried out by 
    allowing the analyzer to analyze the audit test atmosphere in its 
    normal sampling mode such that the test atmosphere passes through 
    all filters, scrubbers, conditioners, and other sample inlet 
    components used during normal ambient sampling and as much of the 
    ambient air inlet system as is practicable. The exception provided 
    in section 3.1 of this Appendix for certain CO analyzers does not 
    apply for audits.
        3.2.1.7 Open path analyzers are audited by inserting a test cell 
    containing the various audit gas concentrations into the optical 
    measurement beam of the instrument. If possible, the normally used 
    transmitter, receiver, and, as appropriate, reflecting devices 
    should be used during the audit, and the normal monitoring 
    configuration of the instrument should be modified as little as 
    possible to accommodate the test cell for the audit. However, if 
    permitted by the associated operation or instruction manual, an 
    alternate local light source or an alternate optical path that does 
    not include the normal atmospheric monitoring path may be used. The 
    actual concentrations of the audit gas in the test cell must be 
    selected to produce effective concentrations in the ranges specified 
    in this section 3.2 of this Appendix.
    
    [[Page 38836]]
    
    Generally, each audit concentration measurement result will be the 
    sum of the atmospheric pollutant concentration and the audit test 
    concentration. If so, the result must be corrected to remove the 
    atmospheric concentration contribution. The corrected concentration 
    is obtained by subtracting the average of the atmospheric 
    concentrations measured by the open path instrument under test 
    immediately before and immediately after the audit test (or 
    preferably before and after each audit concentration level) from the 
    audit concentration measurement. If the difference between the 
    before and after measurements is greater than 20 percent of the 
    effective concentration of the test gas standard, discard the test 
    result for that concentration level and repeat the test for that 
    level. If possible, open path analyzers should be audited during 
    periods when the atmospheric pollutant concentrations are relatively 
    low and steady. Also, the monitoring path length must be reverified 
    to within 3 percent to validate the audit, since the 
    monitoring path length is critical to the determination of the 
    effective concentration.
        3.2.1.8 Report both the actual concentrations (effective 
    concentrations for open path analyzers) of the audit gases and the 
    corresponding concentration measurements (corrected concentrations, 
    if applicable, for open path analyzers) indicated or produced by the 
    analyzer being tested. The percent differences between these 
    concentrations are used to assess the accuracy of the monitoring 
    data as described in section 5.2 of this Appendix.
        3.2.2 Methods for Particulate Matter Excluding PM2.5.
        3.2.2.1 Each calendar quarter, audit the flow rate of at least 
    25 percent of the SLAMS PM10 analyzers such that each 
    PM10 analyzer is audited at least once per year. If there 
    are fewer than four PM10 analyzers within a reporting 
    organization, randomly re-audit one or more analyzers so that at 
    least one analyzer is audited each calendar quarter. Where possible, 
    EPA strongly encourages more frequent auditing, up to an audit 
    frequency of once per quarter for each SLAMS analyzer.
        3.2.2.2 The audit is made by measuring the analyzer's normal 
    operating flow rate, using a flow rate transfer standard certified 
    in accordance with section 2.3.3 of this Appendix. The flow rate 
    standard used for auditing must not be the same flow rate standard 
    used to calibrate the analyzer. However, both the calibration 
    standard and the audit standard may be referenced to the same 
    primary flow rate or volume standard. Great care must be used in 
    auditing the flow rate to be certain that the flow measurement 
    device does not alter the normal operating flow rate of the 
    analyzer. Report the audit (actual) flow rate and the corresponding 
    flow rate indicated or assumed by the sampler. The percent 
    differences between these flow rates are used to calculate accuracy 
    (PM10) as described in section 5.2 of this Appendix.
        3.3 Precision of Manual Methods Excluding PM2.5.
        3.3.1 For each network of manual methods other than for 
    PM2.5, select one or more monitoring sites within the 
    reporting organization for duplicate, collocated sampling as 
    follows: for 1 to 5 sites, select 1 site; for 6 to 20 sites, select 
    2 sites; and for over 20 sites, select 3 sites. Where possible, 
    additional collocated sampling is encouraged. For purposes of 
    precision assessment, networks for measuring TSP and PM10 
    shall be considered separately from one another. PM10 and 
    TSP sites having annual mean particulate matter concentrations among 
    the highest 25 percent of the annual mean concentrations for all the 
    sites in the network must be selected or, if such sites are 
    impractical, alternative sites approved by the Regional 
    Administrator may be selected.
        3.3.2 In determining the number of collocated sites required for 
    PM10, monitoring networks for lead should be treated 
    independently from networks for particulate matter, even though the 
    separate networks may share one or more common samplers. However, a 
    single pair of samplers collocated at a common-sampler monitoring 
    site that meets the requirements for both a collocated lead site and 
    a collocated particulate matter site may serve as a collocated site 
    for both networks.
        3.3.3 The two collocated samplers must be within 4 meters of 
    each other, and particulate matter samplers must be at least 2 
    meters apart to preclude airflow interference. Calibration, 
    sampling, and analysis must be the same for both collocated samplers 
    and the same as for all other samplers in the network.
        3.3.4 For each pair of collocated samplers, designate one 
    sampler as the primary sampler whose samples will be used to report 
    air quality for the site, and designate the other as the duplicate 
    sampler. Each duplicate sampler must be operated concurrently with 
    its associated routine sampler at least once per week. The operation 
    schedule should be selected so that the sampling days are 
    distributed evenly over the year and over the seven days of the 
    week. A six-day sampling schedule is required. Report the 
    measurements from both samplers at each collocated sampling site. 
    The calculations for evaluating precision between the two collocated 
    samplers are described in section 5.3 of this Appendix.
        3.4 Accuracy of Manual Methods Excluding PM2.5. The 
    accuracy of manual sampling methods is assessed by auditing a 
    portion of the measurement process.
        3.4.1 Procedures for PM10 and TSP.
        3.4.1.1 Procedures for flow rate audits for PM10. 
    Each calendar quarter, audit the flow rate of at least 25 percent of 
    the PM10 samplers such that each PM10 sampler 
    is audited at least once per year. If there are fewer than four 
    PM10 samplers within a reporting organization, randomly 
    reaudit one or more samplers so that one sampler is audited each 
    calendar quarter. Audit each sampler at its normal operating flow 
    rate, using a flow rate transfer standard certified in accordance 
    with section 2.3.3 of this Appendix. The flow rate standard used for 
    auditing must not be the same flow rate standard used to calibrate 
    the sampler. However, both the calibration standard and the audit 
    standard may be referenced to the same primary flow rate standard. 
    The flow audit should be scheduled so as to avoid interference with 
    a scheduled sampling period. Report the audit (actual) flow rate and 
    the corresponding flow rate indicated by the sampler's normally used 
    flow indicator. The percent differences between these flow rates are 
    used to calculate accuracy and bias as described in section 5.4.1 of 
    this Appendix.
        3.4.1.2 Great care must be used in auditing high-volume 
    particulate matter samplers having flow regulators because the 
    introduction of resistance plates in the audit flow standard device 
    can cause abnormal flow patterns at the point of flow sensing. For 
    this reason, the flow audit standard should be used with a normal 
    filter in place and without resistance plates in auditing flow-
    regulated high-volume samplers, or other steps should be taken to 
    assure that flow patterns are not perturbed at the point of flow 
    sensing.
        3.4.2 SO2 Methods.
        3.4.2.1 Prepare audit solutions from a working sulfite-
    tetrachloromercurate (TCM) solution as described in section 10.2 of 
    the SO2 Reference Method (40 CFR part 50, Appendix A). 
    These audit samples must be prepared independently from the 
    standardized sulfite solutions used in the routine calibration 
    procedure. Sulfite-TCM audit samples must be stored between 0 and 5 
    deg.C and expire 30 days after preparation.
        3.4.2.2 Prepare audit samples in each of the concentration 
    ranges of 0.2-0.3, 0.5-0.6, and 0.8-0.9 g SO2/
    ml. Analyze an audit sample in each of the three ranges at least 
    once each day that samples are analyzed and at least twice per 
    calendar quarter. Report the audit concentrations (in g 
    SO2/ml) and the corresponding indicated concentrations 
    (in g SO2/ml). The percent differences between 
    these concentrations are used to calculate accuracy as described in 
    section 5.4.2 of this Appendix.
        3.4.3 NO2 Methods. Prepare audit solutions from a 
    working sodium nitrite solution as described in the appropriate 
    equivalent method (see Reference 8 of this Appendix). These audit 
    samples must be prepared independently from the standardized nitrite 
    solutions used in the routine calibration procedure. Sodium nitrite 
    audit samples expire in 3 months after preparation. Prepare audit 
    samples in each of the concentration ranges of 0.2-0.3, 0.5-0.6, and 
    0.8-0.9 g NO2/ml. Analyze an audit sample in 
    each of the three ranges at least once each day that samples are 
    analyzed and at least twice per calendar quarter. Report the audit 
    concentrations (in g NO2/ml) and the 
    corresponding indicated concentrations (in g 
    NO2/ml). The percent differences between these 
    concentrations are used to calculate accuracy as described in 
    section 5.4.2 of this Appendix.
        3.4.4 Pb Methods.
        3.4.4.1 For the Pb Reference Method (40 CFR part 50, Appendix 
    G), the flow rates of the high-volume Pb samplers shall be audited 
    as part of the TSP network using the same procedures described in 
    section 3.4.1 of this Appendix. For agencies operating both TSP and 
    Pb networks, 25 percent of the total number of high-volume samplers 
    are to be audited each quarter.
        3.4.4.2 Each calendar quarter, audit the Pb Reference Method 
    analytical procedure using
    
    [[Page 38837]]
    
    glass fiber filter strips containing a known quantity of Pb. These 
    audit sample strips are prepared by depositing a Pb solution on 
    unexposed glass fiber filter strips of dimensions 1.9 cm by 20.3 cm 
    (3/4 inch by 8 inch) and allowing them to dry thoroughly. The audit 
    samples must be prepared using batches of reagents different from 
    those used to calibrate the Pb analytical equipment being audited. 
    Prepare audit samples in the following concentration ranges:
    
    ------------------------------------------------------------------------
                                                               Equivalent   
                                                 Pb            Ambient Pb   
                    Range                  Concentration,    Concentration, 
                                          g/Strip    g/m3 
    ---------------------------------------------------------------\1\------
    1...................................           100-300           0.5-1.5
    2...................................          600-1000          3.0-5.0 
    ------------------------------------------------------------------------
    \1\ Equivalent ambient Pb concentration in g/m3 is based on    
      sampling at 1.7 m3/min for 24 hours on a 20.3 cm x 25.4 cm (8 inch x  
      10 inch) glass fiber filter.                                          
    
        3.4.4.3 Audit samples must be extracted using the same 
    extraction procedure used for exposed filters.
        3.4.4.4 Analyze three audit samples in each of the two ranges 
    each quarter samples are analyzed. The audit sample analyses shall 
    be distributed as much as possible over the entire calendar quarter. 
    Report the audit concentrations (in g Pb/strip) and the 
    corresponding measured concentrations (in g Pb/strip) using 
    unit code 77. The percent differences between the concentrations are 
    used to calculate analytical accuracy as described in section 5.4.2 
    of this Appendix.
        3.4.4.5 The accuracy of an equivalent Pb method is assessed in 
    the same manner as for the reference method. The flow auditing 
    device and Pb analysis audit samples must be compatible with the 
    specific requirements of the equivalent method.
        3.5 Measurement Uncertainty for Automated and Manual 
    PM2.5 Methods. The goal for acceptable measurement 
    uncertainty has been defined as 10 percent coefficient of variation 
    (CV) for total precision and  10 percent for total bias 
    (Reference 14 of this Appendix).
        3.5.1 Flow Rate Audits.
        3.5.1.1 Automated methods for PM2.5. A one-point 
    precision check must be performed at least once every 2 weeks on 
    each automated analyzer used to measure PM2.5. The 
    precision check is made by checking the operational flow rate of the 
    analyzer. If a precision flow rate check is made in conjunction with 
    a flow rate adjustment, it must be made prior to such flow rate 
    adjustment. Randomization of the precision check with respect to 
    time of day, day of week, and routine service and adjustments is 
    encouraged where possible.
        3.5.1.1.1 Standard procedure: Use a flow rate transfer standard 
    certified in accordance with section 2.3.3 of this Appendix to check 
    the analyzer's normal flow rate. Care should be used in selecting 
    and using the flow rate measurement device such that it does not 
    alter the normal operating flow rate of the analyzer. Report the 
    actual analyzer flow rate measured by the transfer standard and the 
    corresponding flow rate measured, indicated, or assumed by the 
    analyzer.
        3.5.1.1.2 Alternative procedure: It is permissible to obtain the 
    precision check flow rate data from the analyzer's internal flow 
    meter without the use of an external flow rate transfer standard, 
    provided that the flow meter is audited with an external flow rate 
    transfer standard at least every 6 months; records of at least the 
    three most recent flow audits of the instrument's internal flow 
    meter over at least several weeks confirm that the flow meter is 
    stable, verifiable and accurate to 4%; and the 
    instrument and flow meter give no indication of improper operation. 
    With suitable communication capability, the precision check may thus 
    be carried out remotely. For this procedure, report the set-point 
    flow rate as the actual flow rate along with the flow rate measured 
    or indicated by the analyzer flow meter.
        3.5.1.1.3 For either procedure, the differences between the 
    actual and indicated flow rates are used to assess the precision of 
    the monitoring data as described in section 5.5 of this Appendix.
        3.5.1.2 Manual methods for PM2.5. Each calendar 
    quarter, audit the flow rate of each SLAMS PM2.5 
    analyzer. The audit is made by measuring the analyzer's normal 
    operating flow rate, using a flow rate transfer standard certified 
    in accordance with section 2.3.3 of this Appendix. The flow rate 
    standard used for auditing must not be the same flow rate standard 
    used to calibrate the analyzer. However, both the calibration 
    standard and the audit standard may be referenced to the same 
    primary flow rate or volume standard. Great care must be used in 
    auditing the flow rate to be certain that the flow measurement 
    device does not alter the normal operating flow rate of the 
    analyzer. Report the audit (actual) flow rate and the corresponding 
    flow rate indicated or assumed by the sampler. The procedures used 
    to calculate measurement uncertainty PM2.5 are described 
    in section 5.5 of this Appendix.
        3.5.2 Measurement of Precision using Collocated Procedures for 
    Automated and Manual Methods of PM2.5.
        (a) For PM2.5 sites within a reporting organization 
    each EPA designated Federal reference method (FRM) or Federal 
    equivalent method (FEM) must:
        (1) Have 25 percent of the monitors collocated (values of .5 and 
    greater round up).
        (2) Have at least 1 collocated monitor (if the total number of 
    monitors is less than 4). The first collocated monitor must be a 
    designated FRM monitor.
        (b) In addition, monitors selected must also meet the following 
    requirements:
        (1) A monitor designated as an EPA FRM shall be collocated with 
    a monitor having the same EPA FRM designation.
        (2) For each monitor designated as an EPA FEM, 50 percent of the 
    designated monitors shall be collocated with a monitor having the 
    same method designation and 50 percent of the monitors shall be 
    collocated with an FRM monitor. If there are an odd number of 
    collocated monitors required, the additional monitor shall be an 
    FRM. An example of this procedure is found in Table A-2 of this 
    Appendix.
        (c) For PM2.5 sites during the initial deployment of 
    the SLAMS network, special emphasis should be placed on those sites 
    in areas likely to be in violation of the NAAQS. Once areas are 
    initially determined to be in violation, the collocated monitors 
    should be deployed according to the following protocol:
        (1) Eighty percent of the collocated monitors should be deployed 
    at sites with concentrations  ninety percent of the 
    annual PM2.5 NAAQS (or 24-hour NAAQS if that is affecting 
    the area); one hundred percent if all sites have concentrations 
    above either NAAQS, and each area determined to be in violation 
    should be represented by at least one collocated monitor.
        (2) The remaining 20 percent of the collocated monitors should 
    be deployed at sites with concentrations < ninety="" percent="" of="" the="" annual="">2.5 NAAQS (or 24-hour NAAQS if that is affecting 
    the area)
        (3) If an organization has no sites at concentration ranges 
     ninety percent of the annual PM2.5 NAAQS (or 
    24-hour NAAQS if that is affecting the area), 60 percent of the 
    collocated monitors should be deployed at those sites with the 
    annual mean PM2.5 concentrations (or 24-hour NAAQS if 
    that is affecting the area) among the highest 25 percent for all 
    PM2.5 sites in the network.
        3.5.2.1 In determining the number of collocated sites required 
    for PM2.5, monitoring networks for visibility should not 
    be treated independently from networks for particulate matter, as 
    the separate networks may share one or more common samplers. 
    However, for class I visibility areas, EPA will accept visibility 
    aerosol mass measurement instead of a PM2.5 measurement 
    if the latter measurement is unavailable. Any PM2.5 
    monitoring site which does not have a monitor which is an EPA 
    federal reference or equivalent method is not required to be 
    included in the number of sites which are used to determine the 
    number of collocated monitors.
        3.5.2.2 The two collocated samplers must be within 4 meters of 
    each other, and particulate matter samplers must be at least 2 
    meters apart to preclude airflow interference. Calibration, 
    sampling, and analysis must be the same for both collocated samplers 
    and the same as for all other samplers in the network.
        3.5.2.3 For each pair of collocated samplers, designate one 
    sampler as the primary sampler whose samples will be used to report 
    air quality for the site, and designate the other as the duplicate 
    sampler. Each duplicate sampler must be operated concurrently with 
    its associated primary sampler. The operation schedule should be 
    selected so that the sampling days are distributed evenly over the 
    year and over the 7 days of the week and therefore, a 6-day sampling 
    schedule is required. Report the measurements from both samplers at 
    each collocated sampling site. The calculations for evaluating 
    precision between the two collocated samplers are described in 
    section 5.5 of this Appendix.
        3.5.3 Measurement of Bias using the FRM Audit Procedures for 
    Automated and Manual Methods of PM2.5.
        3.5.3.1 The FRM audit is an independent assessment of the total 
    measurement system bias. These audits will be performed under the 
    National Performance Audit Program
    
    [[Page 38838]]
    
    (section 2.4 of this Appendix) or a comparable program. Twenty-five 
    percent of the SLAMS monitors within each reporting organization 
    will be assessed with an FRM audit each year. Additionally, every 
    designated FRM or FEM within a reporting organization must:
        (a) Have at least 25 percent of each method designation audited, 
    including collocated sites (even those collocated with FRM 
    instruments), (values of .5 and greater round up).
        (b) Have at least one monitor audited.
        (c) Be audited at a frequency of four audits per year.
        (d) Have all FRM or FEM samples subject to an FRM audit at least 
    once every 4 years. Table A-2 illustrates the procedure mentioned 
    above.
        3.5.3.2 For PM2.5 sites during the initial deployment 
    of the SLAMS network, special emphasis should be placed on those 
    sites in areas likely to be in violation of the NAAQS. Once areas 
    are initially determined to be in violation, the FRM audit program 
    should be implemented according to the following protocol:
        (a) Eighty percent of the FRM audits should be deployed at sites 
    with concentrations  ninety percent of the annual 
    PM2.5 NAAQS (or 24-hour NAAQS if that is affecting the 
    area); one hundred percent if all sites have concentrations above 
    either NAAQS, and each area determined to be in violation should 
    implement an FRM audit at a minimum of one monitor within that area.
        (b) The remaining 20 percent of the FRM audits should be 
    implemented at sites with concentrations < ninety="" percent="" of="" the="" annual="">2.5 NAAQS (or 24-hour NAAQS if that is affecting 
    the area).
        (c) If an organization has no sites at concentration ranges 
     ninety percent of the annual PM2.5 NAAQS (or 
    24-hour NAAQS if that is affecting the area), 60 percent of the FRM 
    audits should be implemented at those sites with the annual mean 
    PM2.5 concentrations (or 24-hour NAAQS if that is 
    affecting the area) among the highest 25 percent for all 
    PM2.5 sites in the network. Additional information 
    concerning the FRM audit program is contained in Reference 7 of this 
    Appendix. The calculations for evaluating bias between the primary 
    monitor and the FRM audit are described in section 5.5.
    4. Reporting Requirements.
        (a) For each pollutant, prepare a list of all monitoring sites 
    and their AIRS site identification codes in each reporting 
    organization and submit the list to the appropriate EPA Regional 
    Office, with a copy to AIRS-AQS. Whenever there is a change in this 
    list of monitoring sites in a reporting organization, report this 
    change to the Regional Office and to AIRS-AQS.
        4.1 Quarterly Reports. For each quarter, each reporting 
    organization shall report to AIRS-AQS directly (or via the 
    appropriate EPA Regional Office for organizations not direct users 
    of AIRS) the results of all valid precision, bias and accuracy tests 
    it has carried out during the quarter. The quarterly reports of 
    precision, bias and accuracy data must be submitted consistent with 
    the data reporting requirements specified for air quality data as 
    set forth in Sec. 58.35(c). EPA strongly encourages early submittal 
    of the QA data in order to assist the State and Local agencies in 
    controlling and evaluating the quality of the ambient air SLAMS 
    data. Each organization shall report all QA/QC measurements. Report 
    results from invalid tests, from tests carried out during a time 
    period for which ambient data immediately prior or subsequent to the 
    tests were invalidated for appropriate reasons, and from tests of 
    methods or analyzers not approved for use in SLAMS monitoring 
    networks under Appendix C of this part. Such data should be flagged 
    so that it will not be utilized for quantitative assessment of 
    precision, bias and accuracy.
        4.2 Annual Reports.
        4.2.1 When precision, bias and accuracy estimates for a 
    reporting organization have been calculated for all four quarters of 
    the calendar year, EPA will calculate and report the measurement 
    uncertainty for the entire calendar year. These limits will then be 
    associated with the data submitted in the annual SLAMS report 
    required by Sec.  58.26.
        4.2.2 Each reporting organization shall submit, along with its 
    annual SLAMS report, a listing by pollutant of all monitoring sites 
    in the reporting organization.
    5. Calculations for Data Quality Assessment.
        (a) Calculations of measurement uncertainty are carried out by 
    EPA according to the following procedures. Reporting organizations 
    should report the data for individual precision, bias and accuracy 
    tests as specified in sections 3 and 4 of this Appendix even though 
    they may elect to perform some or all of the calculations in this 
    section on their own.
        5.1 Precision of Automated Methods Excluding PM2.5. 
    Estimates of the precision of automated methods are calculated from 
    the results of biweekly precision checks as specified in section 3.1 
    of this Appendix. At the end of each calendar quarter, an integrated 
    precision probability interval for all SLAMS analyzers in the 
    organization is calculated for each pollutant.
        5.1.1 Single Analyzer Precision.
        5.1.1.1 The percent difference (di) for each 
    precision check is calculated using equation 1, where Yi 
    is the concentration indicated by the analyzer for the I-th 
    precision check and Xi is the known concentration for the 
    I-th precision check, as follows:
    
    Equation 1
    [GRAPHIC] [TIFF OMITTED] TR18JY97.138
    
        5.1.1.2 For each analyzer, the quarterly average (dj) 
    is calculated with equation 2, and the standard deviation 
    (Sj) with equation 3, where n is the number of precision 
    checks on the instrument made during the calendar quarter. For 
    example, n should be 6 or 7 if precision checks are made biweekly 
    during a quarter. Equation 2 and 3 follow:
    
    Equation 2
    [GRAPHIC] [TIFF OMITTED] TR18JY97.139
    
    Equation 3
    [GRAPHIC] [TIFF OMITTED] TR18JY97.140
    
        5.1.2 Precision for Reporting Organization.
        5.1.2.1 For each pollutant, the average of averages (D) and the 
    pooled standard deviation (Sa) are calculated for all 
    analyzers audited for the pollutant during the quarter, using either 
    equations 4 and 5 or 4a and 5a, where k is the number of analyzers 
    audited within the reporting organization for a single pollutant, as 
    follows:
    
    Equation 4
    [GRAPHIC] [TIFF OMITTED] TR18JY97.141
    
    Equation 4a
    [GRAPHIC] [TIFF OMITTED] TR18JY97.142
    
    Equation 5
    [GRAPHIC] [TIFF OMITTED] TR18JY97.143
    
    Equation 5a
    [GRAPHIC] [TIFF OMITTED] TR18JY97.144
    
        5.1.2.2 Equations 4 and 5 are used when the same number of 
    precision checks are made for each analyzer. Equations 4a and 5a are 
    used to obtain a weighted average and a weighted standard deviation 
    when different numbers of precision checks are made for the 
    analyzers.
        5.1.2.3 For each pollutant, the 95 Percent Probability Limits 
    for the precision of a reporting organization are calculated using 
    equations 6 and 7, as follows:
    
    [[Page 38839]]
    
    Equation 6
    [GRAPHIC] [TIFF OMITTED] TR18JY97.145
    
    Equation 7
    [GRAPHIC] [TIFF OMITTED] TR18JY97.146
    
        5.2 Accuracy of Automated Methods Excluding PM2.5. 
    Estimates of the accuracy of automated methods are calculated from 
    the results of independent audits as described in section 3.2 of 
    this Appendix. At the end of each calendar quarter, an integrated 
    accuracy probability interval for all SLAMS analyzers audited in the 
    reporting organization is calculated for each pollutant. Separate 
    probability limits are calculated for each audit concentration level 
    in section 3.2 of this Appendix.
        5.2.1 Single Analyzer Accuracy. The percentage difference 
    (di) for each audit concentration is calculated using 
    equation 1, where Yi is the analyzer's indicated 
    concentration measurement from the I-th audit check and 
    Xi is the actual concentration of the audit gas used for 
    the I-th audit check.
        5.2.2 Accuracy for Reporting Organization.
        5.2.2.1 For each audit concentration level of a particular 
    pollutant, the average (D) of the individual percentage differences 
    (di) for all n analyzers audited during the quarter is 
    calculated using equation 8, as follows:
    
    Equation 8
    [GRAPHIC] [TIFF OMITTED] TR18JY97.147
    
        5.2.2.2 For each concentration level of a particular pollutant, 
    the standard deviation (Sa) of all the individual 
    percentage differences for all n analyzers audited during the 
    quarter is calculated, using equation 9, as follows:
    
    Equation 9
    [GRAPHIC] [TIFF OMITTED] TR18JY97.148
    
        5.2.2.3 For reporting organizations having four or fewer 
    analyzers for a particular pollutant, only one audit is required 
    each quarter. For such reporting organizations, the audit results of 
    two consecutive quarters are required to calculate an average and a 
    standard deviation, using equations 8 and 9. Therefore, the 
    reporting of probability limits shall be on a semiannual (instead of 
    a quarterly) basis.
        5.2.2.4 For each pollutant, the 95 Percent Probability Limits 
    for the accuracy of a reporting organization are calculated at each 
    audit concentration level using equations 6 and 7.
        5.3 Precision of Manual Methods Excluding PM2.5. 
    Estimates of precision of manual methods are calculated from the 
    results obtained from collocated samplers as described in section 
    3.3 of this Appendix. At the end of each calendar quarter, an 
    integrated precision probability interval for all collocated 
    samplers operating in the reporting organization is calculated for 
    each manual method network.
        5.3.1 Single Sampler Precision.
        5.3.1.1 At low concentrations, agreement between the 
    measurements of collocated samplers, expressed as percent 
    differences, may be relatively poor. For this reason, collocated 
    measurement pairs are selected for use in the precision calculations 
    only when both measurements are above the following limits:
        (a) TSP: 20 g/m3.
        (b) SO2: 45 g/m3.
        (c) NO2: 30 g/m3.
        (d) Pb: 0.15 g/m3.
        (e) PM10: 20 g/m3.
        5.3.1.2 For each selected measurement pair, the percent 
    difference (di) is calculated, using equation 10, as 
    follows:
    
    Equation 10
    [GRAPHIC] [TIFF OMITTED] TR18JY97.149
    
    where:
    Yi is the pollutant concentration measurement obtained 
    from the duplicate sampler; and
    Xi is the concentration measurement obtained from the 
    primary sampler designated for reporting air quality for the site.
        (a) For each site, the quarterly average percent difference 
    (dj) is calculated from equation 2 and the standard 
    deviation (Sj) is calculated from equation 3, where n= 
    the number of selected measurement pairs at the site.
        5.3.2 Precision for Reporting Organization.
        5.3.2.1 For each pollutant, the average percentage difference 
    (D) and the pooled standard deviation (Sa) are 
    calculated, using equations 4 and 5, or using equations 4a and 5a if 
    different numbers of paired measurements are obtained at the 
    collocated sites. For these calculations, the k of equations 4, 4a, 
    5 and 5a is the number of collocated sites.
        5.3.2.2 The 95 Percent Probability Limits for the integrated 
    precision for a reporting organization are calculated using 
    equations 11 and 12, as follows:
    
    Equation 11
    [GRAPHIC] [TIFF OMITTED] TR18JY97.150
    
    Equation 12
    [GRAPHIC] [TIFF OMITTED] TR18JY97.151
    
        5.4 Accuracy of Manual Methods Excluding PM2.5. 
    Estimates of the accuracy of manual methods are calculated from the 
    results of independent audits as described in section 3.4 of this 
    Appendix. At the end of each calendar quarter, an integrated 
    accuracy probability interval is calculated for each manual method 
    network operated by the reporting organization.
        5.4.1 Particulate Matter Samplers other than PM2.5 
    (including reference method Pb samplers).
        5.4.1.1 Single Sampler Accuracy. For the flow rate audit 
    described in section 3.4.1 of this Appendix, the percentage 
    difference (di) for each audit is calculated using 
    equation 1, where Xi represents the known flow rate and 
    Yi represents the flow rate indicated by the sampler.
        5.4.1.2 Accuracy for Reporting Organization. For each type of 
    particulate matter measured (e.g., TSP/Pb), the average (D) of the 
    individual percent differences for all similar particulate matter 
    samplers audited during the calendar quarter is calculated using 
    equation 8. The standard deviation (Sa) of the percentage 
    differences for all of the similar particulate matter samplers 
    audited during the calendar quarter is calculated using equation 9. 
    The 95 Percent Probability Limits for the integrated accuracy for 
    the reporting organization are calculated using equations 6 and 7. 
    For reporting organizations having four or fewer particulate matter 
    samplers of one type, only one audit is required each quarter, and 
    the audit results of two consecutive quarters are required to 
    calculate an average and a standard deviation. In that case, 
    probability limits shall be reported semi-annually rather than 
    quarterly.
        5.4.2 Analytical Methods for SO2, NO2, and 
    Pb.
        5.4.2.1 Single Analysis-Day Accuracy. For each of the audits of 
    the analytical methods for SO2, NO2, and Pb 
    described in sections 3.4.2, 3.4.3, and 3.4.4 of this Appendix, the 
    percentage difference (dj) at each concentration level is 
    calculated using equation 1, where Xj represents the 
    known value of the audit sample and Yj represents the 
    value of SO2, NO2, or Pb indicated by the 
    analytical method.
        5.4.2.2 Accuracy for Reporting Organization. For each analytical 
    method, the average (D) of the individual percent differences at 
    each concentration level for all audits during the calendar quarter 
    is calculated using equation 8. The standard deviation 
    (Sa) of the percentage differences at each concentration 
    level for all audits during the calendar quarter is calculated using 
    equation 9. The 95 Percent Probability Limits for the accuracy for 
    the reporting organization are calculated using equations 6 and 7.
        5.5 Precision, Accuracy and Bias for Automated and Manual 
    PM2.5 Methods.
        (a) Reporting organizations are required to report the data that 
    will allow assessments of the following individual quality control 
    checks and audits:
        (1) Flow rate audit.
        (2) Collocated samplers, where the duplicate sampler is not an 
    FRM device.
        (3) Collocated samplers, where the duplicate sampler is an FRM 
    device.
        (4) FRM audits.
        (b) EPA uses the reported results to derive precision, accuracy 
    and bias estimates according to the following procedures.
        5.5.1 Flow Rate Audits. The reporting organization shall report 
    both the audit standard flow rate and the flow rate indicated by the 
    sampling instrument. These results are
    
    [[Page 38840]]
    
    used by EPA to calculate flow rate accuracy and bias estimates.
        5.5.1.1 Accuracy of a Single Sampler - Single Check (Quarterly) 
    Basis (di). The percentage difference (di) for 
    a single flow rate audit di is calculated using Equation 
    13, where Xi represents the audit standard flow rate 
    (known) and Yi represents the indicated flow rate, as 
    follows:
    
    Equation 13
    [GRAPHIC] [TIFF OMITTED] TR18JY97.152
    
        5.5.1.2 Bias of a Single Sampler - Annual Basis (Dj). 
    For an individual particulate sampler j, the average (Dj) 
    of the individual percentage differences (di) during the 
    calendar year is calculated using Equation 14, where nj 
    is the number of individual percentage differences produced for 
    sampler j during the calendar year, as follows:
    
    Equation 14
    [GRAPHIC] [TIFF OMITTED] TR18JY97.153
    
        5.5.1.3 Bias for Each EPA Federal Reference and Equivalent 
    Method Designation Employed by Each Reporting Organization - 
    Quarterly Basis (Dk,q). For method designation k used by 
    the reporting organization, quarter q's single sampler percentage 
    differences (di) are averaged using Equation 16, where 
    nk,q is the number of individual percentage differences 
    produced for method designation k in quarter q, as follows:
    
    Equation 15
    [GRAPHIC] [TIFF OMITTED] TR18JY97.154
    
        5.5.1.4 Bias for Each Reporting Organization - Quarterly Basis 
    (Dq). For each reporting organization, quarter q's single 
    sampler percentage differences (di) are averaged using 
    Equation 16, to produce a single average for each reporting 
    organization, where nq is the total number of single 
    sampler percentage differences for all federal reference or 
    equivalent methods of samplers in quarter q, as follows:
    
    Equation 16
    [GRAPHIC] [TIFF OMITTED] TR18JY97.155
    
        5.5.1.5 Bias for Each EPA Federal Reference and Equivalent 
    Method Designation Employed by Each Reporting Organization - Annual 
    Basis (Dk). For method designation k used by the 
    reporting organization, the annual average percentage difference, 
    Dk, is derived using Equation 17, where Dk,q 
    is the average reported for method designation k during the qth 
    quarter, and nk,q is the number of the method designation 
    k's monitors that were deployed during the qth quarter, as follows:
    
    Equation 17
    [GRAPHIC] [TIFF OMITTED] TR18JY97.156
    
        5.5.1.6 Bias for Each Reporting Organization - Annual Basis (D). 
    For each reporting organization, the annual average percentage 
    difference, D, is derived using Equation 18, where Dq is 
    the average reported for the reporting organization during the qth 
    quarter, and nq is the total number monitors that were 
    deployed during the qth quarter. A single annual average is produced 
    for each reporting organization. Equation 18 follows:
    
    Equation 18
    [GRAPHIC] [TIFF OMITTED] TR18JY97.157
    
        5.5.2 Collocated Samplers, Where the Duplicate Sampler is not an 
    FRM Device. (a) At low concentrations, agreement between the 
    measurements of collocated samplers may be relatively poor. For this 
    reason, collocated measurement pairs are selected for use in the 
    precision calculations only when both measurements are above the 
    following limits:
                  PM2.5 : 6 g/m3
    (b) Collocated sampler results are used to assess measurement 
    system precision. A collocated sampler pair consists of a primary 
    sampler (used for routine monitoring) and a duplicate sampler (used 
    as a quality control check). Quarterly precision estimates are 
    calculated by EPA for each pair of collocated samplers and for each 
    method designation employed by each reporting organization. Annual 
    precision estimates are calculated by EPA for each primary sampler, 
    for each EPA Federal reference method and equivalent method 
    designation employed by each reporting organization, and nationally 
    for each EPA Federal reference method and equivalent method 
    designation.
        5.5.2.1 Percent Difference for a Single Check (di). 
    The percentage difference, di, for each check is 
    calculated by EPA using Equation 19, where Xi represents 
    the concentration produced from the primary sampler and 
    Yi represents concentration reported for the duplicate 
    sampler, as follows:
    
    Equation 19
    [GRAPHIC] [TIFF OMITTED] TR18JY97.158
    
        5.5.2.2 Coefficient of Variation (CV) for a Single Check 
    (CVi). The coefficient of variation, CVi, for 
    each check is calculated by EPA by dividing the absolute value of 
    the percentage difference, di, by the square root of two 
    as shown in Equation 20, as follows:
    
    Equation 20
    [GRAPHIC] [TIFF OMITTED] TR18JY97.159
    
        5.5.2.3 Precision of a Single Sampler - Quarterly Basis 
    (CVj,q).
        (a) For particulate sampler j, the individual coefficients of 
    variation (CVj,q) during the quarter are pooled using 
    Equation 21, where nj,q is the number of pairs of 
    measurements from collocated samplers during the quarter, as 
    follows:
    
    Equation 21
    [GRAPHIC] [TIFF OMITTED] TR18JY97.160
    
        (b) The 90 percent confidence limits for the single sampler's CV 
    are calculated by EPA using Equations 22 and 23, where X2 
    0.05,df and X2 0.95,df are the 0.05 
    and 0.95 quantiles of the chi-square (X2) distribution 
    with nj,q degrees of freedom, as follows:
    
    Equation 22
    [GRAPHIC] [TIFF OMITTED] TR18JY97.161
    
    Equation 23
    [GRAPHIC] [TIFF OMITTED] TR18JY97.162
    
        5.5.2.4 Precision of a Single Sampler - Annual Basis. For 
    particulate sampler j, the individual coefficients of variation, 
    CVi, produced during the calendar year are pooled using 
    Equation 21, where nj is the number of checks made during 
    the calendar year. The 90 percent confidence limits for the single 
    sampler's CV are calculated by EPA using Equations 22 and 23, where 
    X2 0.05,df and X2 
    0.95,df are the 0.05 and 0.95 quantiles of the chi-square 
    (X2) distribution with nj degrees of freedom.
        5.5.2.5 Precision for Each EPA Federal Reference Method and 
    Equivalent Method Designation Employed by Each Reporting 
    Organization - Quarterly Basis (CVk,q).
        (a) For each method designation k used by the reporting 
    organization, the quarter's single sampler coefficients of 
    variation, CVj,qs, obtained from Equation 21, are pooled 
    using Equation 24, where nk,q is the number of collocated 
    primary monitors for the designated method (but not collocated with 
    FRM samplers) and nj,q is the number of degrees of 
    freedom associated with CVj,q, as follows:
    
    [[Page 38841]]
    
    Equation 24
    [GRAPHIC] [TIFF OMITTED] TR18JY97.163
    
        (b) The number of method CVs produced for a reporting 
    organization will equal the number of different method designations 
    having more than one primary monitor employed by the organization 
    during the quarter. (When exactly one monitor of a specified 
    designation is used by a reporting organization, it will be 
    collocated with an FRM sampler.)
        5.5.2.6 Precision for Each Method Designation Employed by Each 
    Reporting Organization- Annual Basis (CVk). For each 
    method designation k used by the reporting organization, the 
    quarterly estimated coefficients of variation, CVk,q, are 
    pooled using Equation 25, where nk,q is the number of 
    collocated primary monitors for the designated method during the qth 
    quarter and also the number of degrees of freedom associated with 
    the quarter's precision estimate for the method designation, 
    CVk,q, as follows:
    
    Equation 25
    [GRAPHIC] [TIFF OMITTED] TR18JY97.164
    
        5.5.3 Collocated Samplers, Where the Duplicate Sampler is an FRM 
    Device. At low concentrations, agreement between the measurements of 
    collocated samplers may be relatively poor. For this reason, 
    collocated measurement pairs are selected for use in the precision 
    calculations only when both measurements are above the following 
    limits: PM2.5: 6 g/m3. These 
    duplicate sampler results are used to assess measurement system 
    bias. Quarterly bias estimates are calculated by EPA for each 
    primary sampler and for each method designation employed by each 
    reporting organization. Annual precision estimates are calculated by 
    EPA for each primary monitor, for each method designation employed 
    by each reporting organization, and nationally for each method 
    designation.
        5.5.3.1 Accuracy for a Single Check (d'i). The 
    percentage difference, d'i, for each check is calculated 
    by EPA using Equation 26, where Xi represents the 
    concentration produced from the FRM sampler taken as the true value 
    and Yi represents concentration reported for the primary 
    sampler, as follows:
    
    Equation 26
    [GRAPHIC] [TIFF OMITTED] TR18JY97.165
    
        5.5.3.2 Bias of a Single Sampler - Quarterly Basis 
    (D'j,q).
        (a) For particulate sampler j, the average of the individual 
    percentage differences during the quarter q is calculated by EPA 
    using Equation 27, where nj,q is the number of checks 
    made for sampler j during the calendar quarter, as follows:
    
    Equation 27
    [GRAPHIC] [TIFF OMITTED] TR18JY97.166
    
        (b) The standard deviation, s'j,q, of sampler j's 
    percentage differences for quarter q is calculated using Equation 
    28, as follows:
    
    Equation 28
    [GRAPHIC] [TIFF OMITTED] TR18JY97.167
    
        (c) The 95 Percent Confidence Limits for the single sampler's 
    bias are calculated using Equations 29 and 30 where 
    t0.975,df is the 0.975 quantile of Student's t 
    distribution with df = nj,q-1 degrees of freedom, as 
    follows:
    
    Equation 29
    [GRAPHIC] [TIFF OMITTED] TR18JY97.168
    
    Equation 30
    [GRAPHIC] [TIFF OMITTED] TR18JY97.169
    
        5.5.3.3 Bias of a Single Sampler - Annual Basis 
    (D'j).
        (a) For particulate sampler j, the mean bias for the year is 
    derived from the quarterly bias estimates, D'j,q, using 
    Equation 31, where the variables are as defined for Equations 27 and 
    28, as follows:
    
    Equation 31
    [GRAPHIC] [TIFF OMITTED] TR18JY97.170
    
        (b) The standard error of the above estimate, sej' is 
    calculated using Equation 32, as follows:
    
    Equation 32
    [GRAPHIC] [TIFF OMITTED] TR18JY97.171
    
        (c) The 95 Percent Confidence Limits for the single sampler's 
    bias are calculated using Equations 33 and 34, where 
    t0.975,df is the 0.975 quantile of Student's t 
    distribution with 
    df=(nj,1+nj,2+nj,3+nj,4-
    4) degrees of freedom, as follows:
    
    Equation 33
    [GRAPHIC] [TIFF OMITTED] TR18JY97.172
    
    Equation 34
    [GRAPHIC] [TIFF OMITTED] TR18JY97.173
    
        5.5.3.4 Bias for a Single Reporting Organization (D') - Annual 
    Basis. The reporting organizations mean bias is calculated using 
    Equation 35, where variables are as defined in Equations 31 and 32, 
    as follows:
    
    Equation 35
    [GRAPHIC] [TIFF OMITTED] TR18JY97.174
    
        5.5.4 FRM Audits. FRM Audits are performed once per quarter for 
    selected samplers. The reporting organization reports concentration 
    data from the primary sampler. Calculations for FRM Audits are 
    similar to those for collocated samplers having FRM samplers as 
    duplicates. The calculations differ because only one check is 
    performed per quarter.
        5.5.4.1 Accuracy for a Single Sampler, Quarterly Basis 
    (di). The percentage difference, di, for each 
    check is calculated using Equation 26, where Xi 
    represents the concentration produced from the FRM sampler and 
    Yi represents the concentration reported for the primary 
    sampler. For quarter q, the bias estimate for sampler j is denoted 
    Dj,q.
        5.5.4.2 Bias of a Single Sampler - Annual Basis 
    (D'j). For particulate sampler j, the mean bias for the 
    year is derived from the quarterly bias estimates, Dj,q, 
    using Equation 31, where nj,q equals 1 because one FRM 
    audit is performed per quarter.
        5.5.4.3. Bias for a Single Reporting Organization - Annual Basis 
    (D'). The reporting organizations mean bias is calculated using 
    Equation 35, where variables are as defined in Equations 31 and 32.
    References in Appendix A of Part 58
        (1) Rhodes, R.C. Guideline on the Meaning and Use of Precision 
    and Accuracy Data Required by 40 CFR part 58, Appendices A and B. 
    EPA-600/4-83/023. U.S. Environmental Protection Agency, Research 
    Triangle Park, NC 27711, June, 1983.
        (2) American National Standard--Specifications and Guidelines 
    for Quality
    
    [[Page 38842]]
    
    Systems for Environmental Data Collection and Environmental 
    Technology Programs. ANSI/ASQC E4-1994. January 1995. Available from 
    American Society for Quality Control, 611 East Wisconsin Avenue, 
    Milwaukee, WI 53202.
        (3) EPA Requirements for Quality Management Plans. EPA QA/R-2. 
    August 1994. Available from U.S. Environmental Protection Agency, 
    ORD Publications Office, Center for Environmental Research 
    Information (CERI), 26 W. Martin Luther King Drive, Cincinnati, OH 
    45268.
        (4) EPA Requirements for Quality Assurance Project Plans for 
    Environmental Data Operations. EPA QA/R-5. August 1994. Available 
    from U.S. Environmental Protection Agency, ORD Publications Office, 
    Center for Environmental Research Information (CERI), 26 W. Martin 
    Luther King Drive, Cincinnati, OH 45268.
        (5) Guidance for the Data Quality Objectives Process. EPA QA/G-
    4. September 1994. Available from U.S. Environmental Protection 
    Agency, ORD Publications Office, Center for Environmental Research 
    Information (CERI), 26 W. Martin Luther King Drive, Cincinnati, OH 
    45268.
        (6) Quality Assurance Handbook for Air Pollution Measurement 
    Systems, Volume 1--A Field Guide to Environmental Quality Assurance. 
    EPA-600/R-94/038a. April 1994. Available from U.S. Environmental 
    Protection Agency, ORD Publications Office, Center for Environmental 
    Research Information (CERI), 26 W. Martin Luther King Drive, 
    Cincinnati, OH 45268.
        (7) Quality Assurance Handbook for Air Pollution Measurement 
    Systems, Volume II--Ambient Air Specific Methods EPA-600/R-94/038b. 
    Available from U.S. Environmental Protection Agency, ORD 
    Publications Office, Center for Environmental Research Information 
    (CERI), 26 W. Martin Luther King Drive, Cincinnati, OH 45268.
        (7a) Copies of section 2.12 of the Quality Assurance Handbook 
    for Air Pollution Measurement Systems, are available from Department 
    E (MD-77B), U.S. EPA, Research Triangle Park, NC 27711.
        (8) List of Designated Reference and Equivalent Methods. 
    Available from U.S. Environmental Protection Agency, National 
    Exposure Research Laboratory, Quality Assurance Branch, MD-77B, 
    Research Triangle Park, NC 27711.
        (9) Technical Assistance Document for Sampling and Analysis of 
    Ozone Precursors. Atmospheric Research and Exposure Assessment 
    Laboratory, U.S. Environmental Protection Agency, Research Triangle 
    Park, NC 27711. EPA 600/8-91-215. October 1991.
        (10) EPA Traceability Protocol for Assay and Certification of 
    Gaseous Calibration Standards. EPA-600/R-93/224. September 1993. 
    Available from U.S. Environmental Protection Agency, ORD 
    Publications Office, Center for Environmental Research Information 
    (CERI), 26 W. Martin Luther King Drive, Cincinnati, OH 45268.
        (11) Paur, R.J. and F.F. McElroy. Technical Assistance Document 
    for the Calibration of Ambient Ozone Monitors. EPA-600/4-79-057. 
    U.S. Environmental Protection Agency, Research Triangle Park, NC 
    27711, September, 1979.
        (12) McElroy, F.F. Transfer Standards for the Calibration of 
    Ambient Air Monitoring Analyzers for Ozone. EPA-600/4-79-056. U.S. 
    Environmental Protection Agency, Research Triangle Park, NC 27711, 
    September, 1979.
        (13) Musick, D.R. The Ambient Air Precision and Accuracy 
    Program: 1995 Annual Report. EPA-454/R97001. U.S. Environmental 
    Protection Agency, Research Triangle Park, NC 27711, February 1997.
        (14) Papp, M.L., J,B., Elkins, D.R., Musick and M.J., Messner, 
    Data Quality Objectives for the PM2.5. Monitoring Data, 
    U.S. Environmental Protection Agency, Research Triangle Park, NC 
    27711. In preparation.
        (15) Photochemical Assessment Monitoring Stations Implementation 
    Manual. EPA-454/B-93-051, U.S. Environmental Protection Agency, 
    Research Triangle Park, NC 27711, March 1994.
    
    Tables to Appendix A of Part 58
    
                                    Table A-1.--Minimum Data Assessment Requirements                                
    ----------------------------------------------------------------------------------------------------------------
                                                                                                      Parameters    
                 Method                Assessment Method       Coverage        Minimum Frequency       Reported     
    ----------------------------------------------------------------------------------------------------------------
    Precision:                                                                                                      
        Automated Methods for SO2,    Response check at   Each analyzer       Once per 2 weeks    Actual            
         NO2, O3, and CO               concentration                                               concentration \2\
                                       between .08 and                                             and measured     
                                       .10 ppm (8 & 10                                             concentration \3\
                                       ppm for CO) \2\                                                              
                                                                                                                    
        Manual Methods: All methods   Collocated          1 site for 1-5      Once every six      Particle mass     
         except PM2.5                  samplers            sites               days                concentration    
                                                          2 sites for 6-20                         indicated by     
                                                           sites                                   sampler and by   
                                                          3 sites >20 sites                        collocated       
                                                           (sites with                             sampler          
                                                           highest conc.)                                           
    Accuracy:                                                                                                       
        Automated Methods for SO2,    Response check at   1. Each analyzer    1. Once per year    Actual            
         NO2, O3, and CO              .03-.08 ppm1,2      2. 25% of           2. Each calendar     concentration \2\
                                      .15-.20 ppm1,2       analyzers (at       quarter             and measured     
                                      .35-.45 ppm1,2       least 1)                                (indicated)      
                                      80-.90 ppm1,2 (if                                            concentration \3\
                                       applicable)                                                 for each level   
                                                                                                                    
        Manual Methods for SO2, and   Check of            Analytical system   Each day samples    Actual            
         NO2                           analytical                              are analyzed, at    concentration and
                                       procedure with                          least twice per     measured         
                                       audit standard                          quarter             (indicated)      
                                       solutions                                                   concentration for
                                                                                                   each audit       
                                                                                                   solution         
                                                                                                                    
        TSP, PM10                     Check of sampler    1. Each sampler     1. Once per year    Actual flow rate  
                                       flow rate          2. 25% of samplers  2. Each calendar     and flow rate    
                                                           (at least 1)        quarter             indicated by the 
                                                                                                   sampler          
                                                                                                                    
        Lead                          1. Check of sample  1. Each sampler     1. Include with     1. Same as for TSP
                                       flow rate as for                        TSP                                  
                                       TSP                                                                          
                                      2. Check of         2. Analytical       2. Each quarter     2. Actual         
                                       analytical system   system                                  concentration and
                                       with Pb audit                                               measured         
                                       strips                                                      (indicated)      
                                                                                                   concentration of 
                                                                                                   audit samples    
                                                                                                   (g Pb/  
                                                                                                   strip)           
    PM2.5                                                                                                           
    
    [[Page 38843]]
    
                                                                                                                    
        Manual and Automated Methods- Collocated          25% of SLAMS        Once every six      1. Particle mass  
         Precision.                    samplers            (monitors with      days                concentration    
                                                           Conc affecting                          indicated by     
                                                           NAAQS violation                         sampler and by   
                                                           status)                                 collocated       
                                                                                                   sampler          
                                                                                                  2. 24-hour value  
                                                                                                   for automated    
                                                                                                   methods          
        Manual and Automated Methods- 1. Check of         25% of SLAMS        1. Minimum of       1. Actual flow    
         Accuracy and Bias             sampler flow rate   (monitors with      every calendar      rate and flow    
                                                           Conc affecting      quarter, 4 checks   rate indicated by
                                                           NAAQS violation     per year            sampler          
                                                           status)                                                  
                                      2. Audit with                           2. Minimum 4        2. Particle mass  
                                       reference method                        measurements per    concentration    
                                                                               year                indicated by     
                                                                                                   sampler and by   
                                                                                                   audit reference  
                                                                                                   sampler          
    ----------------------------------------------------------------------------------------------------------------
    \1\ Concentration times 100 for CO.                                                                             
    \2\ Effective concentration for open path analyzers.                                                            
    \3\ Corrected concentration, if applicable, for open path analyzers.                                            
    
    
    
      Table A-2.--Summary of PM2.5 Collocation and Audits Procedures As an Example of a Typical Reporting Organization Needing 43 Monitors, Having Procured 
                                                          FRMs and Three Other Equivalent Method Types                                                      
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                   # of Collocated      # of Independent FRM
             Method Designation            Total # of Monitors     Total # Collocated     # of Collocated FRMs  Monitors of Same Type          Audits       
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    FRM                                            25                       6                      6                     n/a                     6          
    Type A                                         10                       3                      2                      1                      3          
    Type C                                          2                       1                      1                      0                      1          
    Type D                                          6                       2                      1                      1                      2          
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
        m. Appendix C is amended by revising section 2.2 and adding 
    sections 2.2.1 and 2.2.2, adding sections 2.4 through 2.5, revising 
    section 2.7.1, and adding section 2.9 and references 4 through 6 to 
    section 6.0 to read as follows:
    Appendix C--Ambient Air Quality Monitoring Methodology
        *    *    *    *    *
        2.2 Substitute PM10 samplers.
        2.2.1 For purposes of showing compliance with the NAAQS for 
    particulate matter, a high volume TSP sampler described in 40 CFR 
    part 50, Appendix B, may be used in a SLAMS in lieu of a 
    PM10 monitor as long as the ambient concentrations of 
    particles measured by the TSP sampler are below the PM10 
    NAAQS. If the TSP sampler measures a single value that is higher 
    than the PM10 24-hour standard, or if the annual average 
    of its measurements is greater than the PM10 annual 
    standard, the TSP sampler operating as a substitute PM10 
    sampler must be replaced with a PM10 monitor. For a TSP 
    measurement above the 24-hour standard, the TSP sampler should be 
    replaced with a PM10 monitor before the end of the 
    calendar quarter following the quarter in which the high 
    concentration occurred. For a TSP annual average above the annual 
    standard, the PM10 monitor should be operating by June 30 
    of the year following the exceedance.
        2.2.2 In order to maintain historical continuity of ambient 
    particulate matter trends and patterns for PM10 NAMS that 
    were previously TSP NAMS, the TSP high volume sampler must be 
    operated concurrently with the PM10 monitor for a one-
    year period beginning with the PM10 NAMS start-up date. 
    The operating schedule for the TSP sampler must be at least once 
    every 6 days regardless of the PM10 sampling frequency.
        *    *    *    *    *
        2.4 Approval of non-designated PM2.5 methods operated 
    at specific individual sites. A method for PM2.5 that has 
    not been designated as a reference or equivalent method as defined 
    in Sec. 50.1 of this chapter may be approved for use for purposes of 
    section 2.1 of this Appendix at a particular SLAMS under the 
    following stipulations.
        2.4.1 The method must be demonstrated to meet the comparability 
    requirements (except as provided in this section 2.4.1) set forth in 
    Sec. 53.34 of this chapter in each of the four seasons at the site 
    at which it is intended to be used. For purposes of this section 
    2.4.1, the requirements of Sec. 53.34 of this chapter shall apply 
    except as follows:
        2.4.1.1 The method shall be tested at the site at which it is 
    intended to be used, and there shall be no requirement for tests at 
    any other test site.
        2.4.1.2 For purposes of this section 2.4, the seasons shall be 
    defined as follows: Spring shall be the months of March, April, and 
    May; summer shall be the months of June, July, and August; fall 
    shall be the months of September, October, and November; and winter 
    shall be the months of December, January, and February; when 
    alternate seasons are approved by the Administrator.
        2.4.1.3 No PM10 samplers shall be required for the 
    test, as determination of the PM2.5/PM10 ratio 
    at the test site shall not be required.
        2.4.1.4 The specifications given in Table C-4 of part 53 of this 
    chapter for Class I methods shall apply, except that there shall be 
    no requirement for any minimum number of sample sets with Rj greater 
    than 40 g/m3 for 24-hour samples or greater than 
    15 g/m3 average concentration collected over a 
    48-hour period.
        2.4.2 The monitoring agency wishing to use the method must 
    develop and implement appropriate quality assurance procedures for 
    the method.
        2.4.3 The monitoring agency wishing to use the method must 
    develop and implement appropriate procedures for assessing and 
    reporting the precision and accuracy of the method comparable to the 
    procedures set forth in Appendix A of this part for designated 
    reference and equivalent methods.
        2.4.4 The assessment of network operating precision using 
    collocated measurements with reference method ``audit'' samplers 
    required under section 3 of Appendix A of this part shall be carried 
    out semi-annually rather than annually (i.e., monthly audits with 
    assessment determinations each 6 months).
        2.4.5 Requests for approval under this section 2.4 must meet the 
    general submittal requirements of sections 2.7.1 and 2.7.2.1 of this 
    Appendix and must include the requirements in sections 2.4.5.1 
    through 2.4.5.7 of this Appendix.
        2.4.5.1 A clear and unique description of the site at which the 
    method or sampler will be used and tested, and a description of the 
    nature or character of the site and the particulate matter that is 
    expected to occur there.
        2.4.5.2 A detailed description of the method and the nature of 
    the sampler or analyzer upon which it is based.
    
    [[Page 38844]]
    
        2.4.5.3 A brief statement of the reason or rationale for 
    requesting the approval.
        2.4.5.4 A detailed description of the quality assurance 
    procedures that have been developed and that will be implemented for 
    the method.
        2.4.5.5 A detailed description of the procedures for assessing 
    the precision and accuracy of the method that will be implemented 
    for reporting to AIRS.
        2.4.5.6 Test results from the comparability tests as required in 
    section 2.4.1 through 2.4.1.4 of this Appendix.
        2.4.5.7 Such further supplemental information as may be 
    necessary or helpful to support the required statements and test 
    results.
        2.4.6 Within 120 days after receiving a request for approval of 
    the use of a method at a particular site under this section 2.4 and 
    such further information as may be requested for purposes of the 
    decision, the Administrator will approve or disapprove the method by 
    letter to the person or agency requesting such approval.
        2.5 Approval of non-designated methods under Sec. 58.13(f). An 
    automated (continuous) method for PM2.5 that is not 
    designated as either a reference or equivalent method as defined in 
    Sec. 50.1 of this chapter may be approved under Sec. 58.13(f) for 
    use at a SLAMS for the limited purposes of Sec. 58.13(f). Such an 
    analyzer that is approved for use at a SLAMS under Sec.  58.13(f), 
    identified as correlated acceptable continuous (CAC) monitors, shall 
    not be considered a reference or equivalent method as defined in 
    Sec. 50.1 of this chapter by virtue of its approval for use under 
    Sec. 58.13(f), and the PM2.5 monitoring data obtained 
    from such a monitor shall not be otherwise used for purposes of part 
    50 of this chapter.
        *    *    *    *    *
        2.7.1 Requests for approval under sections 2.4, 2.6.2, or 2.8 of 
    this Appendix must be submitted to: Director, National Exposure 
    Assessment Laboratory, Department E, (MD-77B), U.S. Environmental 
    Protection Agency, Research Triangle Park, North Carolina 27711.
        *    *    *    *    *
        2.9 Use of IMPROVE Samplers at a SLAMS. ``IMPROVE'' samplers may 
    be used in SLAMS for monitoring of regional background and regional 
    transport concentrations of fine particulate matter. The IMPROVE 
    samplers were developed for use in the Interagency Monitoring of 
    Protected Visual Environments (IMPROVE) network to characterize all 
    of the major components and many trace constituents of the 
    particulate matter that impair visibility in Federal Class I Areas. 
    These samplers are routinely operated at about 70 locations in the 
    United States. IMPROVE samplers consist of four sampling modules 
    that are used to collect twice weekly 24-hour duration simultaneous 
    samples. Modules A, B, and C collect PM2.5 on three 
    different filter substrates that are compatible with a variety of 
    analytical techniques, and module D collects a PM10 
    sample. PM2.5 mass and elemental concentrations are 
    determined by analysis of the 25mm diameter stretched Teflon filters 
    from module A. More complete descriptions of the IMPROVE samplers 
    and the data they collect are available elsewhere (References 4, 5, 
    and 6 of this Appendix).
        *    *    *    *    *
    6.0 References.
        *    *    *    *    *
        (4) Eldred, R.A., Cahill, T.A., Wilkenson, L.K., et al., 
    Measurements of fine particles and their chemical components in the 
    IMPROVE/NPS networks, in Transactions of the International Specialty 
    Conference on Visibility and Fine Particles, Air and Waste 
    Management Association: Pittsburgh, PA, 1990; pp 187-196.
        (5) Sisler, J.F., Huffman, D., and Latimer, D.A.; Spatial and 
    temporal patterns and the chemical composition of the haze in the 
    United States: An analysis of data from the IMPROVE network, 1988-
    1991, ISSN No. 0737-5253-26, National Park Service, Ft. Collins, CO, 
    1993.
        (6) Eldred, R.A., Cahill, T.A., Pitchford, M., and Malm, W.C.; 
    IMPROVE--a new remote area particulate monitoring system for 
    visibility studies, Proceedings of the 81st Annual Meeting of the 
    Air Pollution Control Association, Dallas, Paper 88-54.3, 1988.
        n. Appendix D is amended by revising in the table of contents the 
    entries for 2.8, 3.7, 4., and 5. and adding an entry for 6., by 
    revising the first three paragraphs and Table 1 of section 1., revising 
    the second paragraph in section 2. and adding a new paragraph to the 
    end of the section before section 2.1, revising section 2.8 and adding 
    sections 2.8.0.1 through 2.8.2.3, revising the third and fifth 
    paragraphs in section 3., revising section 3.7 and adding sections 
    3.7.1 through 3.7.7.4, revising the sixth paragraph in section 4.2 and 
    redesignating Figures 1 and 2 as Figures 5 and 6 respectively, and 
    revising the redesignated figures, revising footnote 3 of Table 2 of 
    section 4.4, revising section 5. and reference 18 in section 6. to read 
    as follows:
    Appendix D--Network Design for State and Local Air Monitoring Stations 
    (SLAMS), National Air Monitoring Stations (NAMS), and Photochemical 
    Assessment Monitoring Stations (PAMS)
        *    *    *    *    *
        2.8 Particulate Matter Design Criteria for SLAMS
        *    *    *    *    *
        3.7 Particulate Matter Design Criteria for NAMS
        4. Network Design for Photochemical Assessment Monitoring 
    Stations (PAMS)
        5. Summary
        6. References
    1. SLAMS Monitoring Objectives and Spatial Scales.
        The purpose of this Appendix is to describe monitoring 
    objectives and general criteria to be applied in establishing the 
    State and Local Air Monitoring Stations (SLAMS) networks and for 
    choosing general locations for new monitoring stations. It also 
    describes criteria for determining the number and location of 
    National Air Monitoring Stations (NAMS), Photochemical Assessment 
    Monitoring Stations (PAMS), and core Stations for PM2.5. 
    These criteria will also be used by EPA in evaluating the adequacy 
    of the SLAMS/NAMS/PAMS and core PM2.5 networks.
        The network of stations that comprise SLAMS should be designed 
    to meet a minimum of six basic monitoring objectives. These basic 
    monitoring objectives are:
        (1) To determine highest concentrations expected to occur in the 
    area covered by the network.
        (2) To determine representative concentrations in areas of high 
    population density.
        (3) To determine the impact on ambient pollution levels of 
    significant sources or source categories.
        (4) To determine general background concentration levels.
        (5) To determine the extent of Regional pollutant transport 
    among populated areas; and in support of secondary standards.
        (6) To determine the welfare-related impacts in more rural and 
    remote areas (such as visibility impairment and effects on 
    vegetation).
        It should be noted that this Appendix contains no criteria for 
    determining the total number of stations in SLAMS networks, except 
    that a minimum number of lead SLAMS and PM2.5 are 
    prescribed and the minimal network introduced in Sec. 58.20 is 
    explained. The optimum size of a particular SLAMS network involves 
    trade offs among data needs and available resources that EPA 
    believes can best be resolved during the network design process.
        *    *    *    *    *
    
         Table 1.--Relationship Among Monitoring Objectives and Scale of    
                               Representativeness                           
    ------------------------------------------------------------------------
               Monitoring Objective               Appropriate Siting Scales 
    ------------------------------------------------------------------------
    Highest concentration.....................  Micro, Middle, neighborhood 
                                                 (sometimes urban1)         
    Population................................  Neighborhood, urban         
    Source impact.............................  Micro, middle, neighborhood 
    General/background........................  Neighborhood, urban,        
                                                 regional                   
    Regional transport........................  Urban/regional              
    Welfare-related impacts...................  Urban/regional              
    ------------------------------------------------------------------------
    1 Urban denotes a geographic scale applicable to both cities and rural  
      areas                                                                 
    
        *    *    *    *    *
    2. SLAMS Network Design Procedures.
        *    *    *    *    *
        The discussion of scales in sections 2.3 through 2.8 of this 
    Appendix does not include all of the possible scales for each 
    pollutant. The scales that are discussed are those that are felt to 
    be most pertinent for SLAMS network design.
        *    *    *    *    *
        Information such as emissions density, housing density, 
    climatological data, geographic information, traffic counts, and the 
    results of modeling will be useful in designing regulatory networks. 
    Air pollution control agencies have shown the value of
    
    [[Page 38845]]
    
    screening studies, such as intensive studies conducted with portable 
    samplers, in designing networks. In many cases, in selecting sites 
    for core PM2.5 or carbon monoxide SLAMS, and for defining 
    the boundaries of PM2.5 optional community monitoring 
    zones, air pollution control agencies will benefit from using such 
    studies to evaluate the spatial distribution of pollutants.
        *    *    *    *    *
        2.8 Particulate Matter Design Criteria for SLAMS.
        As with other pollutants measured in the SLAMS network, the 
    first step in designing the particulate matter network is to collect 
    the necessary background information. Various studies in References 
    11, 12, 13, 14, 15, and 16 of section 6 of this Appendix have 
    documented the major source categories of particulate matter and 
    their contribution to ambient levels in various locations throughout 
    the country.
        2.8.0.1 Sources of background information would be regional and 
    traffic maps, and aerial photographs showing topography, 
    settlements, major industries and highways. These maps and 
    photographs would be used to identify areas of the type that are of 
    concern to the particular monitoring objective. After potentially 
    suitable monitoring areas for particulate matter have been 
    identified on a map, modeling may be used to provide an estimate of 
    particulate matter concentrations throughout the area of interest. 
    After completing the first step, existing particulate matter 
    stations should be evaluated to determine their potential as 
    candidates for SLAMS designation. Stations meeting one or more of 
    the six basic monitoring objectives described in section 1 of this 
    Appendix must be classified into one of the five scales of 
    representativeness (micro, middle, neighborhood, urban and regional) 
    if the stations are to become SLAMS. In siting and classifying 
    particulate matter stations, the procedures in references 17 and 18 
    of section 6 of this Appendix should be used.
        2.8.0.2 The most important spatial scales to effectively 
    characterize the emissions of particulate matter from both mobile 
    and stationary sources are the middle scales for PM10 and 
    neighborhood scales for both PM10 and PM2.5. 
    For purposes of establishing monitoring stations to represent large 
    homogenous areas other than the above scales of representativeness 
    and to characterize regional transport, urban or regional scale 
    stations would also be needed. Most PM2.5 monitoring in 
    urban areas should be representative of a neighborhood scale.
        2.8.0.3 Microscale--This scale would typify areas such as 
    downtown street canyons and traffic corridors where the general 
    public would be exposed to maximum concentrations from mobile 
    sources. In some circumstances, the microscale is appropriate for 
    particulate stations; core SLAMS on the microscale should, however, 
    be limited to urban sites that are representative of long-term human 
    exposure and of many such microenvironments in the area. In general, 
    microscale particulate matter sites should be located near inhabited 
    buildings or locations where the general public can be expected to 
    be exposed to the concentration measured. Emissions from stationary 
    sources such as primary and secondary smelters, power plants, and 
    other large industrial processes may, under certain plume 
    conditions, likewise result in high ground level concentrations at 
    the microscale. In the latter case, the microscale would represent 
    an area impacted by the plume with dimensions extending up to 
    approximately 100 meters. Data collected at microscale stations 
    provide information for evaluating and developing hot spot control 
    measures. Unless these sites are indicative of population-oriented 
    monitoring, they may be more appropriately classified as SPMs.
        2.8.0.4 Middle Scale--Much of the measurement of short-term 
    public exposure to coarse fraction particles (PM10) is on 
    this scale and on the neighborhood scale; for fine particulate, much 
    of the measurement is on the neighborhood scale. People moving 
    through downtown areas, or living near major roadways, encounter 
    particles that would be adequately characterized by measurements of 
    this spatial scale. Thus, measurements of this type would be 
    appropriate for the evaluation of possible short-term exposure 
    public health effects of particulate matter pollution. In many 
    situations, monitoring sites that are representative of micro-scale 
    or middle-scale impacts are not unique and are representative of 
    many similar situations. This can occur along traffic corridors or 
    other locations in a residential district. In this case, one 
    location is representative of a neighborhood of small scale sites 
    and is appropriate for evaluation of long-term or chronic effects. 
    This scale also includes the characteristic concentrations for other 
    areas with dimensions of a few hundred meters such as the parking 
    lot and feeder streets associated with shopping centers, stadia, and 
    office buildings. In the case of PM10, unpaved or seldom 
    swept parking lots associated with these sources could be an 
    important source in addition to the vehicular emissions themselves.
        2.8.0.5 Neighborhood Scale--Measurements in this category would 
    represent conditions throughout some reasonably homogeneous urban 
    subregion with dimensions of a few kilometers and of generally more 
    regular shape than the middle scale. Homogeneity refers to the 
    particulate matter concentrations, as well as the land use and land 
    surface characteristics. Much of the PM2.5 exposures are 
    expected to be associated with this scale of measurement. In some 
    cases, a location carefully chosen to provide neighborhood scale 
    data would represent not only the immediate neighborhood but also 
    neighborhoods of the same type in other parts of the city. Stations 
    of this kind provide good information about trends and compliance 
    with standards because they often represent conditions in areas 
    where people commonly live and work for periods comparable to those 
    specified in the NAAQS. In general, most PM2.5 monitoring 
    in urban areas should have this scale. A PM2.5 monitoring 
    location is assumed to be representative of a neighborhood scale 
    unless the monitor is adjacent to a recognized PM2.5 
    emissions source or is otherwise demonstrated to be representative 
    of a smaller spatial scale by an intensive monitoring study. This 
    category also may include industrial and commercial neighborhoods 
    especially in districts of diverse land use where residences are 
    interspersed.
        2.8.0.6 Neighborhood scale data could provide valuable 
    information for developing, testing, and revising models that 
    describe the larger-scale concentration patterns, especially those 
    models relying on spatially smoothed emission fields for inputs. The 
    neighborhood scale measurements could also be used for neighborhood 
    comparisons within or between cities. This is the most likely scale 
    of measurements to meet the needs of planners.
        2.8.0.7 Urban Scale--This class of measurement would be made to 
    characterize the particulate matter concentration over an entire 
    metropolitan or rural area ranging in size from 4 to 50 km. Such 
    measurements would be useful for assessing trends in area-wide air 
    quality, and hence, the effectiveness of large scale air pollution 
    control strategies. Core PM2.5 SLAMS may have this scale.
        2.8.0.8 Regional Scale--These measurements would characterize 
    conditions over areas with dimensions of as much as hundreds of 
    kilometers. As noted earlier, using representative conditions for an 
    area implies some degree of homogeneity in that area. For this 
    reason, regional scale measurements would be most applicable to 
    sparsely populated areas with reasonably uniform ground cover. Data 
    characteristics of this scale would provide information about larger 
    scale processes of particulate matter emissions, losses and 
    transport. Especially in the case of PM2.5, transport 
    contributes to particulate concentrations and may affect multiple 
    urban and State entities with large populations such as in the 
    Eastern United States. Development of effective pollution control 
    strategies requires an understanding at regional geographical scales 
    of the emission sources and atmospheric processes that are 
    responsible for elevated PM2.5 levels and may also be 
    associated with elevated ozone and regional haze.
        2.8.1 Specific Design Criteria for PM2.5.
        2.8.1.1 Monitoring Planning Areas.
        Monitoring planning areas (MPAs) shall be used to conform to the 
    community-oriented monitoring approach used for the PM2.5 
    NAAQS given in part 50 of this chapter. MPAs are required to 
    correspond to all metropolitan statistical areas (MSAs) with 
    population greater than 200,000, and all other areas determined to 
    be in violation of the PM2.5 NAAQS.1 MPAs for 
    other designated parts of the State are optional. All MPAs shall be 
    defined on the basis of existing, delineated mapping data such as 
    State boundaries, county boundaries, zip codes, census blocks, or 
    census block groups.
    ---------------------------------------------------------------------------
    
        1The boundaries of MPAs do not have to necessarily correspond to 
    those of MSAs and existing intra or interstate air pollution 
    planning districts may be utilized.
    ---------------------------------------------------------------------------
    
        2.8.1.2 PM2.5 Monitoring Sites within the State's PM 
    Monitoring Network Description.
        2.8.1.2.1 The minimum required number, type of monitoring sites, 
    and sampling
    
    [[Page 38846]]
    
    requirements for PM2.5 are based on monitoring planning 
    areas described in the PM monitoring network description and 
    proposed by the State in accordance with Sec. 58.20.
        2.8.1.2.2 Comparisons to the PM2.5 NAAQS may be based 
    on data from SPMs in addition to SLAMS (including NAMS, core SLAMS 
    and collocated PM2.5 sites at PAMS), that meet the 
    requirements of Sec. 58.13 and Appendices A, C and E of this part, 
    that are included in the PM monitoring network description. For 
    comparison to the annual NAAQS, the monitors should be neighborhood 
    scale community-oriented locations. Special purpose monitors that 
    meet part 58 requirements will be exempt from NAAQS comparisons with 
    the PM2.5 NAAQS for the first 2 calendar years of their 
    operation to encourage PM2.5 monitoring initially. After 
    this time, however, any SPM that records a violation of the 
    PM2.5 NAAQS must be seriously considered as a potential 
    SLAMS site during the annual SLAMS network review in accordance with 
    Sec. 58.25. If such SPMs are not established as a SLAMS, the agency 
    must document in its annual report the technical basis for excluding 
    it as a SLAMS.
        2.8.1.2.3 The health-effects data base that served as the basis 
    for selecting the new PM2.5 standards relied on a spatial 
    average approach that reflects average community-oriented area-wide 
    PM exposure levels. Under this approach, the most effective way to 
    reduce total population risk is by lowering the annual distributions 
    of ambient 24-hour PM2.5 concentrations, as opposed to 
    controlling peak 24-hour concentrations on individual days. The 
    annual standard selected by EPA will generally be the controlling 
    standard for lowering both short- and long-term PM2.5 
    concentrations on an area-wide basis and will achieve this result. 
    In order to be consistent with this rationale, therefore, 
    PM2.5 data collected from SLAMS and special purpose 
    monitors that are representative, not of area-wide but rather, of 
    relatively unique population-oriented microscale, or localized hot 
    spot, or unique population-oriented middle-scale impact sites are 
    only eligible for comparison only to the 24-hour PM2.5 
    NAAQS. However, in instances where certain population-oriented 
    micro- or middle-scale PM2.5 monitoring sites are 
    determined by the EPA Regional Administrator to collectively 
    identify a larger region of localized high ambient PM2.5 
    concentrations, data from these population-oriented sites would be 
    eligible for comparison to the annual NAAQS.
        2.8.1.2.4 Within each MPA, the responsible air pollution control 
    agency shall install core SLAMS, other required SLAMS and as many 
    PM2.5 stations judged necessary to satisfy the SLAMS 
    requirements and monitoring objectives of this Appendix.
        2.8.1.3 Core Monitoring Stations for PM2.5.
        Core monitoring stations or sites are a subset of the SLAMS 
    network for PM2.5 that are sited to represent community-
    wide air quality. These core sites include sites to be collocated at 
    PAMS.
        2.8.1.3.1 Within each monitoring planning area, the responsible 
    air pollution control agency shall install the following core 
    PM2.5 SLAMS:
        (a) At least two core PM2.5 SLAMS per MSA with 
    population greater than 500,000 sampling everyday, unless exempted 
    by the Regional Administrator, including at least one station in a 
    population-oriented area of expected maximum concentration and at 
    least one station in an area of poor air quality and at least one 
    additional core monitor collocated at a PAMS site if the MPA is also 
    a PAMS area2.
    ---------------------------------------------------------------------------
    
        2The core monitor to be collocated at a PAMS site shall not be 
    considered a part of the PAMS as described in section 4 of this 
    Appendix, but shall instead be considered to be a component of the 
    particular MPA PM2.5 network.
    ---------------------------------------------------------------------------
    
        (b) At least one core PM2.5 SLAMS per MSA with 
    population greater than 200,000 and less than or equal to 500,000 
    sampling every third day.
        (c) Additional core PM2.5 SLAMS per MSA with 
    population greater than 1 million, sampling every third day, as 
    specified in the following table:
    
       Table 1.--Required Number of Core SLAMS According to MSA Population  
    ------------------------------------------------------------------------
                                                Minimum Required No. of Core
                  MSA Population                           Sites1           
    ------------------------------------------------------------------------
    >1 M                                        3                           
    ------------------------------------------------------------------------
    >2 M                                        4                           
    ------------------------------------------------------------------------
    >4 M                                        6                           
    ------------------------------------------------------------------------
    >6 M                                        8                           
    ------------------------------------------------------------------------
    >8 M                                        10                          
    ------------------------------------------------------------------------
    1Core SLAMS at PAMS are in addition to these numbers.                   
    
        2.8.1.3.2 The site situated in the area of expected maximum 
    concentration is analogous to NAMS ``category a.'' 3 This 
    will henceforth be termed a category a core SLAMS site. The site 
    located in the area of poor air quality with high population density 
    or representative of maximum population impact is analogous to NAMS, 
    ``category b.'' This second site will be called a category b core 
    SLAMS site.
    ---------------------------------------------------------------------------
    
        3The measured maximum concentrations at core population-oriented 
    sites should be consistent with the averaging time of the NAAQS. 
    Therefore, sites only with high concentrations for shorter averaging 
    times (say 1-hour) should not be category ``a'' core SLAMS monitors.
    ---------------------------------------------------------------------------
    
        2.8.1.3.3 Those MPAs that are substantially impacted by several 
    different and geographically disjoint local sources of fine 
    particulate should have separate core sites to monitor each 
    influencing source region.
        2.8.1.3.4 Within each monitoring planning area, one or more 
    required core SLAMS may be exempted by the Regional Administrator. 
    This may be appropriate in areas where the highest concentration is 
    expected to occur at the same location as the area of maximum or 
    sensitive population impact, or areas with low concentrations (e.g., 
    highest concentrations are less than 80 percent of the NAAQS). When 
    only one core monitor for PM2.5 is included in a MPA or 
    optional CMZ, however, a ``category a'' core site is strongly 
    preferred to determine community-oriented PM2.5 
    concentrations in areas of high average PM2.5 
    concentration.
        2.8.1.3.5 More than the minimum number of core SLAMS should be 
    deployed as necessary in all MPAs. Except for the core SLAMS 
    described in section 2.8.1.3.1 of this Appendix, the additional core 
    SLAMS must only comply with the minimum sampling frequency for SLAMS 
    specified in Sec. 58.13(e).
        2.8.1.3.6 A subset of the core PM2.5 SLAMS shall be 
    designated NAMS as discussed in section 3.7 of this Appendix. The 
    selection of core monitoring sites in relation to MPAs and CMZs is 
    discussed further in section 2.8.3 of this Appendix.
        2.8.1.3.7 Core monitoring sites shall represent neighborhood or 
    larger spatial scales. A monitor that is established in the ambient 
    air that is in or near a populated area, and meets appropriate 40 
    CFR part 58 criteria (i.e., meets the requirements of Sec. 58.13 and 
    Sec. 58.14, Appendices A, C, and E of this part) can be presumed to 
    be representative of at least a neighborhood scale, is eligible to 
    be called a core site and shall produce data that are eligible for 
    comparison to both the 24-hour and annual PM2.5 NAAQS. If 
    the site is adjacent to a dominating local source or can be shown to 
    have average 24-hour concentrations representative of a smaller 
    spatial scale, then the site would only be compared to the 24-hour 
    PM2.5 NAAQS.
        2.8.1.3.8 Continuous fine particulate monitoring at core SLAMS. 
    At least one continuous fine particulate analyzer (e.g., beta 
    attenuation analyzer; tapered-element, oscillating microbalance 
    (TEOM); transmissometer; nephelometer; or other acceptable 
    continuous fine particulate monitor) shall be located at a core 
    monitoring PM2.5 site in each metropolitan area with a 
    population greater than 1 million. These analyzers shall be used to 
    provide improved temporal resolution to better understand the 
    processes and causes of elevated PM2.5 concentrations and 
    to facilitate public reporting of PM2.5 air quality and 
    will be in accordance with appropriate methodologies and QA/QC 
    procedures approved by the Regional Administrator.
        2.8.1.4 Other PM2.5 SLAMS Locations.
        In addition to the required core sites described in section 
    2.8.1.3 of this Appendix, the State shall also install and operate 
    on an every third day sampling schedule at least one SLAMS to 
    monitor for regional background and at least one SLAMS to monitor 
    regional transport. These monitoring stations may be at a community-
    oriented site and their requirement may be satisfied by a 
    corresponding SLAMS monitor in an area having similar air quality in 
    another State. The State shall also be required to establish 
    additional SLAMS sites based on the total population outside the 
    MSA(s) associated with monitoring planning areas that contain 
    required core SLAMS. There shall be one such additional SLAMS for 
    each 200,000 people. The minimum number of SLAMS may be deployed 
    anywhere in the State to satisfy the SLAMS monitoring objectives 
    including monitoring of small scale impacts which may not be 
    community-oriented or for regional transport as described in section 
    1
    
    [[Page 38847]]
    
    of this Appendix. Other SLAMS may also be established and are 
    encouraged in a State PM2.5 network.
        2.8.1.5 Additional PM2.5 Analysis Requirements.
        (a) Within 1 year after September 16, 1997, chemical speciation 
    will be required at approximately 25 PM2.5 core sites 
    collocated at PAMS sites (1 type 2 site per PAMS area) and at 
    approximately 25 other core sites for a total of approximately 50 
    sites. The selection of these sites will be performed by the 
    Administrator in consultation with the Regional Administrator and 
    the States. Chemical speciation is encouraged at additional sites. 
    At a minimum, chemical speciation to be conducted will include 
    analysis for elements, selected anions and cations, and carbon. 
    Samples for required speciation will be collected using appropriate 
    monitoring methods and sampling schedule in accordance with 
    procedures approved by the Administrator.
        (b) Air pollution control agencies shall archive 
    PM2.5 filters from all other SLAMS sites for a minimum of 
    one year after collection. These filters shall be made available for 
    supplemental analyses at the request of EPA or to provide 
    information to State and local agencies on the composition for 
    PM2.5. The filters shall be archived in accordance with 
    procedures approved by the Administrator.
        2.8.1.6 Community Monitoring Zones.
        2.8.1.6.1 The CMZs describe areas within which two or more core 
    monitors may be averaged for comparison with the annual 
    PM2.5 NAAQS. This averaging approach as specified in 40 
    CFR part 50, Appendix N, is directly related to epidemiological 
    studies used as the basis for the PM2.5 NAAQS. A CMZ 
    should characterize an area of relatively similar annual average air 
    quality (i.e., the average concentrations at individual sites shall 
    not exceed the spatial average by more than 20 percent) and exhibit 
    similar day to day variability (e.g., the monitoring sites should 
    not have low correlations, say less than 0.6). Moreover, the entire 
    CMZ should principally be affected by the same major emission 
    sources of PM2.5 .
        2.8.1.6.2 Each monitoring planning area may have at least one 
    CMZ, that may or may not cover the entire MPA. In metropolitan 
    statistical areas (MSAs) for which MPAs are required, the CMZs may 
    completely cover the entire MSA. When more than one CMZ is described 
    within an MPA, CMZs shall not overlap in their geographical 
    coverage. All areas in the ambient air may become a CMZ.
        2.8.1.6.3. As PM2.5 networks are first established, 
    core sites would be used individually for making comparisons to the 
    annual PM2.5 NAAQS. As these networks evolve, individual 
    monitors may not be adequate by themselves to characterize the 
    annual average community wide air quality. This is especially true 
    for areas with sharp gradients in annual average air quality. 
    Therefore, CMZs with multiple core SLAMS or other eligible sites as 
    described in accordance with section 2.8.1.2 to this Appendix, may 
    be established for the purposes of providing improved estimates of 
    community wide air quality and for making comparisons to the annual 
    NAAQS. This CMZ approach is subject to the constraints of section 
    2.8.1.6.1 to this Appendix.
        2.8.1.6.4 The spatial representativeness of individual 
    monitoring sites should be considered in the design of the network 
    and in establishing the boundaries of CMZs. Communities within the 
    MPA with the highest PM2.5 concentrations must have a 
    high priority for PM2.5 monitoring. Until a sufficient 
    number of monitoring stations or CMZs are established, however, the 
    monitored air quality in all parts of the MPA may not be precisely 
    known. It would be desirable, however, to design the placement of 
    monitors so that those portions of the MPAs without monitors could 
    be characterized as having average concentrations less than the 
    monitored portions of the network.
        2.8.1.7 Selection of Monitoring Locations Within MPAs or CMZs.
        2.8.1.7.1 Figure 1 of this Appendix illustrates a hypothetical 
    monitoring planning area and shows the location of monitors in 
    relation to population and areas of poor air quality. Figure 2 of 
    this Appendix shows the same hypothetical MPA as Figure 1 of this 
    Appendix and illustrates potential community monitoring zones and 
    the location of core monitoring sites within them. Figure 3 of this 
    Appendix illustrates which sites within the CMZs of the same MPA may 
    be used for comparison to the PM2.5 NAAQS.
        2.8.1.7.2 In Figure 1 of this Appendix, a hypothetical 
    monitoring planning area is shown representing a typical Eastern US 
    urban areas. The ellipses represent zones with relatively high 
    population and poor air quality, respectively. Concentration 
    isopleths are also depicted. The highest population density is 
    indicated by the urban icons, while the area of worst air quality is 
    presumed to be near the industrial symbols. The monitoring area 
    should have at least one core monitor to represent community wide 
    air quality in each sub-area affected by different emission sources. 
    Each monitoring planning area with population greater than 500,000 
    is required to have at least two core population-oriented monitors 
    that will sample everyday (with PAMS areas requiring three) and may 
    have as many other core SLAMS, other SLAMS, and SPMs as necessary. 
    All SLAMS should generally be population-oriented, while the SPMs 
    can focus more on other monitoring objectives, e.g., identifying 
    source impacts and the area boundaries with maximum concentration. 
    Ca denotes ``category a'' core SLAMS site (community-
    oriented site in area of expected maximum concentration); it is 
    shown within the populated area and closest to the area with highest 
    concentration. Cb denotes a ``category b'' core SLAMS 
    site (area of poor air quality with high population density or 
    representative of maximum population impact); it is shown in the 
    area of poor air quality, closest to highest population density. S 
    denotes other SLAMS sites (monitoring for any objective: Max 
    concentration, population exposure, source-oriented, background, or 
    regional transport or in support of secondary NAAQS). P denotes a 
    Special Purpose Monitor (a specialized monitor that, for example, 
    may use a non-reference sampler). Finally, note that all SPMs would 
    be subject to the 2-year moratorium against data comparison to the 
    NAAQS for the first 2 complete calendar years of its operation.
        2.8.1.7.3 A Monitoring Planning Area may have one or more 
    community monitoring zones (CMZ) for aggregation of data from 
    eligible SLAMS and SPM sites for comparison to the annual NAAQS. The 
    planning area has large gradients of average air quality and, as 
    shown in Figure 2 may be assigned three CMZs: An industrial zone, a 
    downtown central business district (CBD), and a residential area. 
    (If there is not a large difference between downtown concentrations 
    and other residential areas, a separate CBD zone would not be 
    appropriate).
    
    [[Page 38848]]
    
    [GRAPHIC] [TIFF OMITTED] TR18JY97.175
    
    
        2.8.1.7.4 Figure 3 of this Appendix illustrates how CMZs and 
    PM2.5 monitors might be located in a hypothetical MPA 
    typical of a Western State. Western States with more localized 
    sources of PM and larger geographic area could require a different 
    mix
    
    [[Page 38849]]
    
    of SLAMS and SPM monitors and may need more total monitors. As the 
    networks are deployed, the available monitors may not be sufficient 
    to completely represent all geographic portions of the Monitoring 
    Planning Area. Due to the distribution of pollution and population 
    and because of the number and spatial representativeness of 
    monitors, the MPAs and CMZs may not cover the entire State.
    [GRAPHIC] [TIFF OMITTED] TR18JY97.176
    
        2.8.1.7.5 Figure 4 of this Appendix shows how the MPAs, CMZs, 
    and PM2.5 monitors might be distributed within a 
    hypothetical State. Areas of the State included within MPAs are 
    shown within heavy solid lines. Two MPAs are illustrated. Areas in 
    the State outside the MPAs will also include monitors, but this 
    monitoring coverage may be limited. This portion of the State may 
    also be represented by CMZs (shown by areas enclosed within dotted 
    lines). The monitors that are intended for comparison to the NAAQS 
    are indicated by X. Furthermore, eligible monitors within a CMZ 
    could be averaged for comparison to the annual NAAQS or examined 
    individually for comparison to both NAAQS. Both within the MPAs and 
    in the remainder of the State, some special study monitors might not 
    satisfy applicable 40 CFR part 58 requirements and will not be 
    eligible for comparison to the NAAQS.
    
    [[Page 38850]]
    
    [GRAPHIC] [TIFF OMITTED] TR18JY97.177
    
    
        2.8.2 Substitute PM Monitoring Sites.
        2.8.2.1 Section 2.2 of Appendix C of this part describes 
    conditions under which TSP samplers can be used as substitutes for 
    PM10. This provision is intended to be used when 
    PM10 concentrations are expected to be very low and 
    substitute TSP samplers can be used to satisfy the minimum number of 
    PM10 samplers needed for an adequate PM10 
    network.
        2.8.2.2 If data produced by substitute PM samplers exceed the 
    concentration levels described in Appendix C of this part, then the 
    need for this sampler to be converted to a PM10 or 
    PM2.5 sampler, shall be considered in the PM monitoring 
    network review. If the State does not believe that a PM10 
    or PM2.5 sampler should be sited, the State shall submit 
    documentation to EPA as part of its annual PM report to justify this 
    decision. If a PM site is not designated as a substitute site in the 
    PM monitoring network description, then high concentrations at this 
    site would not necessarily cause this site to become a 
    PM2.5 or PM10 site, whichever is indicated.
        2.8.2.3 Consistent with Sec. 58.1, combinations of SLAMS 
    PM10 or PM2.5 monitors and other monitors may 
    occupy the same structure without any mutual effect on the 
    regulatory definition of the monitors.
    3. Network Design for National Air Monitoring Stations (NAMS).
        *    *    *    *    *
        Category (a): Stations located in area(s) of expected maximum 
    concentrations, generally microscale for CO, microscale or middle 
    scale for Pb, middle scale or neighborhood scale for population-
    oriented particulate matter, urban or regional scale for Regional 
    transport PM2.5, neighborhood scale for SO2, and NO2, and 
    urban scale for O3.
        *    *    *    *    *
        For each MSA where NAMS are required, both categories of 
    monitoring stations must be established. In the case of 
    SO2 if only one NAMS is needed, then category (a) must be 
    used. The analysis and interpretation of data from NAMS should 
    consider the distinction between these types of stations as 
    appropriate.
        *    *    *    *    *
        3.7 Particulate Matter Design Criteria for NAMS.
        3.7.1 Table 4 indicates the approximate number of permanent 
    stations required in MSAs to characterize national and regional 
    PM10 air quality trends and geographical patterns. The 
    number of PM10 stations in areas where MSA populations 
    exceed 1,000,000 must be in the range from 2 to 10 stations, while 
    in low population urban areas, no more than two stations are 
    required. A range of monitoring stations is specified in Table 4 
    because sources of pollutants and local control efforts can vary 
    from one part of the country to another and therefore, some 
    flexibility is allowed in selecting the actual number of stations in 
    any one locale.
        3.7.2 Through promulgation of the NAAQS for PM2.5, 
    the number of PM10 SLAMS is expected to decrease, but 
    requirements to maintain PM10 NAMS remain in effect. The 
    PM10 NAMS are retained to provide trends data, to support 
    national assessments and decisions, and in some cases to continue 
    demonstration that a NAAQS for PM10 is maintained as a 
    requirement under a State Implementation Plan.
        3.7.3 The PM2.5 NAMS shall be a subset of the core 
    PM2.5 SLAMS and other SLAMS intended to monitor for 
    regional transport. The PM2.5 NAMS are planned as long-
    term monitoring stations concentrated in metropolitan areas. A 
    target range of 200 to 300 stations shall be designated nationwide. 
    The largest metropolitan areas (those with a population greater than 
    approximately one million) shall have at least one PM2.5 
    NAMS stations.
        3.7.4 The number of total PM2.5 NAMS per Region will 
    be based on recommendations of the EPA Regional Offices, in concert 
    with
    
    [[Page 38851]]
    
    their State and local agencies, in accordance with the network 
    design goals described in sections 3.7.5 through 3.7.7 of this 
    Appendix. The selected stations should represent the range of 
    conditions occurring in the Regions and will consider factors such 
    as total number or type of sources, ambient concentrations of 
    particulate matter, and regional transport.
        3.7.5 The approach for PM2.5 NAMS is intended to give 
    State and local agencies maximum flexibility while apportioning a 
    limited national network. By advancing a range of monitors per 
    Region, EPA intends to balance the national network with respect to 
    geographic area and population. Table 5 presents the target number 
    of PM2.5 NAMS per Region to meet the national goal of 200 
    to 300 stations. These numbers consider a variety of factors such as 
    Regional differences in metropolitan population, population density, 
    land area, sources of particulate emissions, and the numbers of 
    PM10 NAMS.
        3.7.6 States will be required to establish approximately 50 NAMS 
    sites for routine chemical speciation of PM2.5. These 
    sites will include those collocated at approximately 25 PAMS sites 
    and approximately 25 other core SLAMS sites to be selected by the 
    Administrator. After 5 years of data collection, the Administrator 
    may exempt some sites from collecting speciated data. The number of 
    NAMS sites at which speciation will be performed each year and the 
    number of samples per year will be determined by the Administrator.
        3.7.7 Since emissions associated with the operation of motor 
    vehicles contribute to urban area particulate matter levels, 
    consideration of the impact of these sources must be included in the 
    design of the NAMS network, particularly in MSAs greater than 
    500,000 population. In certain urban areas particulate emissions 
    from motor vehicle diesel exhaust currently is or is expected to be 
    a significant source of particulate matter ambient levels. The 
    actual number of NAMS and their locations must be determined by EPA 
    Regional Offices and the State agencies, subject to the approval of 
    the Administrator as required by Sec. 58.32. The Administrator's 
    approval is necessary to ensure that individual stations conform to 
    the NAMS selection criteria and that the network as a whole is 
    sufficient in terms of number and location for purposes of national 
    analyses.
    
                                 Table 4.--PM10 National Air Monitoring Station Criteria                            
                                        [Approximate Number of Stations per MSA]1                                   
    ----------------------------------------------------------------------------------------------------------------
                                                                           High           Medium            Low     
                           Population Category                        Concentration2  Concentration3  Concentration4
    ----------------------------------------------------------------------------------------------------------------
    >1,000,000......................................................       6-10                4-8           2-4    
    500,000-1,000,000...............................................        4-8                2-4           1-2    
    250,000-500,000.................................................        3-4                1-2           0-1    
    100,000-250,000.................................................        1-2                0-1             0    
    ----------------------------------------------------------------------------------------------------------------
    1 Selection of urban areas and actual number of stations per area will be jointly determined by EPA and the     
      State agency.                                                                                                 
    2 High concentration areas are those for which ambient PM10 data show ambient concentrations exceeding either   
      PM10 NAAQS by 20 percent or more.                                                                             
    3 Medium concentration areas are those for which ambient PM10 data show ambient concentrations exceeding 80     
      percent of the PM10 NAAQS.                                                                                    
    4 Low concentration areas are those for which ambient PM10 data show ambient concentrations less than 80 percent
      of the PM10 NAAQS.                                                                                            
    
        3.7.7.1 Selection of urban areas and actual number of stations 
    per area will be jointly determined by EPA and the State agency.
        3.7.7.2 High concentration areas are those for which: Ambient 
    PM10 data show ambient concentrations exceeding either 
    PM10 NAAQS by 20 percent or more.
        3.7.7.3 Medium concentration areas are those for which: Ambient 
    PM10 data show ambient concentrations exceeding either 80 
    percent of the PM10 NAAQS.
        3.7.7.4 Low concentration areas are those for which: Ambient 
    PM10 data show ambient concentrations less than 80 
    percent of the PM10 NAAQS.
    
               Table 5.--Goals for Number of PM2.5 NAMS by Region           
    ------------------------------------------------------------------------
                                                               Percent of   
                EPA Region                Number of NAMS     National Total 
    -------------------------------------------\1\--------------------------
    1.................................  15 to 20           6 to 8           
    2.................................  20 to 30           8 to 12          
    3.................................  20 to 25           8 to 10          
    4.................................  35 to 50           14 to 20         
    5.................................  35 to 50           14 to 20         
    6.................................  25 to 35           10 to 14         
    7.................................  10 to 15           4 to 6           
    8.................................  10 to 15           4 to 6           
    9.................................  25 to 40           10 to 16         
    10................................  10 to 15           4 to 6           
                                       -------------------------------------
        Total.........................  205-295            100              
    ------------------------------------------------------------------------
    \1\ Each region will have one to three NAMS having the monitoring of    
      regional transport as a primary objective.                            
    
        *    *    *    *    *
        4.2 PAMS Monitoring Objectives.
        *    *    *    *    *
        States choosing to submit an individual network description for 
    each affected nonattainment area, irrespective of its proximity to 
    other affected areas, must fulfill the requirements for isolated 
    areas as described in section 4 of this Appendix, as an example, and 
    illustrated by Figure 5. States containing areas which experience 
    significant impact from long-range transport or are proximate to 
    other nonattainment areas (even in other States) should collectively 
    submit a network description which contains alternative sites to 
    those that would be required for an isolated area. Such a submittal 
    should, as a guide, be based on the example provided in Figure 6, 
    but must include a demonstration that the design satisfies the 
    monitoring data uses and fulfills the PAMS monitoring objectives 
    described in sections 4.1 and 4.2 of this Appendix.
    
    [[Page 38852]]
    
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    [[Page 38853]]
    
    [GRAPHIC] [TIFF OMITTED] TR18JY97.179
    
    
    
    [[Page 38854]]
    
        *    *    *    *    *
        4.4 Minimum Monitoring Network Requirements.
        *    *    *    *    *
        Table 2 * * *
    
        3See Figure 5.
        *    *    *    *    *
    5. Summary.
        Table 6 of this Appendix shows by pollutant, all of the spatial 
    scales that are applicable for SLAMS and the required spatial scales 
    for NAMS. There may also be some situations, as discussed later in 
    Appendix E of this part, where additional scales may be allowed for 
    NAMS purposes.
    
                       Table 6.--Summary of Spatial Scales for SLAMS and Required Scales for NAMS                   
    ----------------------------------------------------------------------------------------------------------------
                                                              Scales Applicable for SLAMS                           
            Spatial Scale        -----------------------------------------------------------------------------------
                                      SO2         CO          O3          NO2         Pb         PM10        PM2.5  
    ----------------------------------------------------------------------------------------------------------------
    Micro.......................                                                        
    Middle......................                                   
    Neighborhood................                                   
    Urban.......................                                          
    Regional....................                                                 
                                                                                                                    
                                                                                                                    
    (6)Scales Required for NAMS                                                                                     
                                                                                                                    
    Micro.......................                                                      1 
    Middle......................                                                             1 
    Neighborhood................                                   
    Urban.......................                                                             2 
    Regional....................                                                                          2  
    ----------------------------------------------------------------------------------------------------------------
    \1\ Only permitted if representative of many such micro-scale environments in a residential district (for middle
      scale, at least two).                                                                                         
    \2\ Either urban or regional scale for regional transport sites.                                                
    
    6. References.
        *    *    *    *    *
        18. Watson et al. Guidance for Network Design and Optimum Site 
    Exposure for PM2.5 and PM10. Prepared for U.S. 
    Environmental Protection Agency, Research Triangle Park, NC.
        o. Appendix E is amended by revising the entry for 8. in the table 
    of contents, by revising the heading to section 8., adding a sentence 
    at the end of the first paragraph of section 8.1, and in section 8.3 
    removing the term ``PM10'' wherever it appears and adding in 
    its place ``PM'' to read as follows:
    Appendix E--Probe and Monitoring Path Siting Criteria for Ambient Air 
    Quality Monitoring
        *    *    *    *    *
        8. Particulate Matter (PM10 and PM2.5)
        *    *    *    *    *
    8. Particulate Matter (PM10 and PM2.5).
        8.1 Vertical Placement * * * Although microscale or middle scale 
    stations are not the preferred spatial scale for PM2.5 
    sites, there are situations where such sites are representative of 
    several locations within an area where large segments of the 
    population may live or work (e.g., central business district of 
    Metropolitan area). In these cases, the sampler inlet for such 
    microscale PM2.5 stations must also be 2-7 meters above 
    ground level.
        *    *    *    *    *
        p. Appendix F is amended by revising in the table of contents the 
    entry for 2.7.3 and adding a new entry for 2.7.4, by redesignating 
    section 2.7.3 as section 2.7.4 and adding a new section 2.7.3 to read 
    as follows:
    Appendix F--Annual SLAMS Air Quality Information
        *    *    *    *    *
        2.7.3 Annual Summary Statistics
    
        2.7.4 Episode and Other Unscheduled Sampling Data
        *    *    *    *    *
        2.7.3 Annual Summary Statistics. Annual arithmetic mean 
    (g/m3) as specified in 40 CFR part 50, Appendix 
    N. All daily PM-fine values above the level of the 24-hour PM-fine 
    NAAQS and dates of occurrence. Sampling schedule used such as once 
    every 6 days, everyday, etc. Number of 24-hour average 
    concentrations in ranges:
    
    ------------------------------------------------------------------------
                                                                  Number of 
                               Range                                Values  
    ------------------------------------------------------------------------
    0 to 15 (g/m\3\)..................................             
    16 to 30...................................................             
    31 to 50...................................................             
    51 to 70...................................................             
    71 to 90...................................................             
    91 to 110..................................................             
    Greater than 110...........................................             
    ------------------------------------------------------------------------
    
    [FR Doc. 97-18579 Filed 7-17-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
9/16/1997
Published:
07/18/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-18579
Dates:
This regulation is effective September 16, 1997.
Pages:
38764-38854 (91 pages)
Docket Numbers:
AD-FRL-5725-6
RINs:
2060-AE66: NAAQS: Particulate Matter (Review)
RIN Links:
https://www.federalregister.gov/regulations/2060-AE66/naaqs-particulate-matter-review-
PDF File:
97-18579.pdf
CFR: (91)
40 CFR 53.64)
40 CFR 53.4(a)
40 CFR 53.51(a),(d
40 CFR 53.9(b).)
40 CFR 53.4(b)(3)
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