Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 40 - Protection of Environment |
Chapter I—Environmental Protection Agency |
SubChapter C—Air Programs |
Part 58 - Ambient Air Quality Surveillance |
Appendix C to Part 58 - —Ambient Air Quality Monitoring Methodology
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Appendix C to Part 58—Ambient Air Quality Monitoring Methodology
1.0 Purpose
2.0 SLAMS Ambient Air Monitoring Stations
3.0 NCore Ambient Air Monitoring Stations
4.0 Photochemical Assessment Monitoring Stations (PAMS)
5.0 Particulate Matter Episode Monitoring
6.0 References
1.0 Purpose
This appendix specifies the criteria pollutant monitoring methods (manual methods or automated analyzers) which must be used in SLAMS and NCore stations that are a subset of SLAMS.
2.0 SLAMS Ambient Air Monitoring Network
2.1 Except as otherwise provided in this appendix, a criteria pollutant monitoring method used for making NAAQS decisions at a SLAMS site must be a reference or equivalent method as defined in § 50.1 of this chapter.
2.1.1 Any NO2 FRM or FEM used for making primary NAAQS decisions must be capable of providing hourly averaged concentration data.
3 Any manual method or analyzer purchased prior to cancellation of its reference or equivalent method designation under § 53.11 or § 53.16 of this chapter may be used at a SLAMS site following cancellation for a reasonable period of time to be determined by the Administrator.2.2 Reserved PM10, PM2.
2.4 Approval of Non-designated Continuous PM2.5 Methods as Approved Regional Methods (ARMs) Operated Within a Network of Sites. A method for PM2.5 that has not been designated as an FRM or FEM as defined in § 50.1 of this chapter may be approved as an ARM for purposes of section 2.1 of this appendix at a particular site or network of sites under the following stipulations.
2.4.22.4.1 The candidate ARM must be demonstrated to meet the requirements for PM2.5 Class III equivalent methods as defined in subpart C of part 53 of this chapter. Specifically the requirements for precision, correlation, and additive and multiplicative bias apply. For purposes of this section 2.4, the following requirements shall apply:
2.4.1.1 The candidate ARM shall be tested at the site(s) in which it is intended to be used. For a network of sites operated by one reporting agency or primary quality assurance organization, the testing shall occur at a subset of sites to include one site in each MSA/CSA, up to the first 2 highest population MSA/CSA and at least one rural area or Micropolitan Statistical Area site. If the candidate ARM for a network is already approved for purposes of this section in another agency's network, subsequent testing shall minimally occur at one site in a MSA/CSA and one rural area or Micropolitan Statistical Area. There shall be no requirement for tests at any other sites.
2.4.1.2 For purposes of this section, a full year of testing may begin and end in any season, so long as all seasons are covered.
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 test specification for PM2.5 Class III equivalent method precision defined in subpart C of part 53 of this chapter applies; however, there is no specific requirement that collocated continuous monitors be operated for purposes of generating a statistic for coefficient of variation (CV). To provide an estimate of precision that meets the requirement identified in subpart C of part 53 of this chapter, agencies may cite peer-reviewed published data or data in AQS that can be presented demonstrating the candidate ARM operated will produce data that meets the specification for precision of Class III PM2.5 methods.
2.4.1.5 A minimum of 90 valid sample pairs per site for the year with no less than 20 valid sample pairs per season must be generated for use in demonstrating that additive bias, multiplicative bias and correlation meet the comparability requirements specified in subpart C of part 53 of this chapter. A valid sample pair may be generated with as little as one valid FRM and one valid candidate ARM measurement per day.
2.4.1.6 For purposes of determining bias, FRM data with concentrations less than 3 micrograms per cubic meter (µg/m3) may be excluded. Exclusion of data does not result in failure of sample completeness specified in this section.
2.4.1.7 Data transformations are allowed to be used to demonstrate meeting the comparability requirements specified in subpart C of part 53 of this chapter. Data transformation may be linear or non-linear, but must be applied in the same way to all sites used in the testing.
5, or PM10-2.5 continuous FEMs with existing valid designations may be calibrated using network data from collocated FRM and continuous FEM data under the following provisions:
2.2.1 Data to demonstrate a calibration may include valid data from State, local, or Tribal air agencies or data collected by instrument manufacturers in accordance with 40 CFR 53.35 or other data approved by the Administrator.
2.2.2 A request to update a designated methods calibration may be initiated by the instrument manufacturer of record or the EPA Administrator. State, local, Tribal, and multijusistincional organizations of these entities may work with an instrument manufacture to update a designated method calibration.
2.2.3 Requests for approval of an updated PM10, PM2.5, or PM10-2.5 continuous FEM calibration must meet the general submittal requirements of section 2.7 of this appendix.
2.2.4 Data included in the request should represent a subset of representative locations where the method is operational. For cases with a small number of collocated FRMs and continuous FEMs sites, an updated candidate calibration may be limited to the sites where both methods are in use.
2.2.5 Data included in a candidate method updated calibration may include a subset of sites where there is a large grouping of sites in one part of the country such that the updated calibration would be representative of the country as a whole.
2.2.6 Improvements should be national in scope and ideally implemented through a firmware change.
2.2.7 The goal of a change to a methods calibration is to increase the number of sites meeting measurements quality objectives of the method as identified in section 2.3.1.1 of appendix A to this part.
2.2.8 For meeting measurement quality objectives (MQOs), the primary objective is to meet the bias goal as this statistic will likely have the most influence on improving the resultant data collected.
2.2.9 Precision data are to be included, but so long as precision data are at least as good as existing network data or meet the MQO referenced in section 2.2.8 of this appendix, no further work is necessary with precision.
2.2.10 Data available to use may include routine primary and collocated data.
2.2.11 Audit data may be useful to confirm the performance of a candidate updated calibration but should not be used as the basis of the calibration to keep the independence of the audit data.
2.2.12 Data utilized as the basis of the updated calibration may be obtained by accessing EPA's AQS database or future analogous EPA database.
2.2.13 Years of data to use in a candidate method calibration should include two recent years where we are past the certification period for the previous year's data, which is May 1 of each year.
2.2.14 Data from additional years is to be used to test an updated calibration such that the calibration is independent of the test years of interest. Data from these additional years need to minimally demonstrate that a larger number of sites are expected to meet bias MQO especially at sites near the level of the NAAQS for the PM indicator of interest.
2.2.15 Outliers may be excluded using routine outlier tests.
2.2.16 The range of data used in a calibration may include all data available or alternatively use data in the range from the lowest measured data available up to 125% of the 24-hour NAAQS for the PM indicator of interest.
2.2.17 Other improvements to a PM continuous method may be included as part of a recommended update so long as appropriate testing is conducted with input from EPA's Office of Research and Development (ORD) Reference and Equivalent (R&E) Methods Designation program.
2.2.18 EPA encourages early communication by instrument manufacturers considering an update to a PM method. Instrument companies should initiate such dialogue by contacting EPA's ORD R&E Methods Designation program. The contact information for this can be found at 40 CFR 53.4.
2.2.19 Manufacturers interested in improving instrument's performance through an updated factory calibration must submit a written modification request to EPA with supporting rationale. Because the testing requirements and acceptance criteria of any field and/or lab tests can depend upon the nature and extent of the intended modification, applicants should contact EPA's R&E Methods Designation program for guidance prior to development of the modification request.
2.3 Any manual method or analyzer purchased prior to cancellation of its reference or equivalent method designation under § 53.11 or § 53.16 of this chapter may be used at a SLAMS site following cancellation for a reasonable period of time to be determined by the Administrator.
2.4 [Reserved]
2.4.1 [Reserved]
2.4.2 The monitoring agency wishing to use an ARM must develop and implement appropriate quality assurance procedures for the method. Additionally, the following procedures are required for the method:
2.4.2.1 The ARM must be consistently operated throughout the network. Exceptions to a consistent operation must be approved according to section 2.8 of this appendix;
2.4.2.2 The ARM must be operated on an hourly sampling frequency capable of providing data suitable for aggregation into daily 24-hour average measurements;
2.4.2.3 The ARM must use an inlet and separation device, as needed, that are already approved in either the reference method identified in appendix L to part 50 of this chapter or under part 53 of this chapter as approved for use on a PM2.5 reference or equivalent method. The only exceptions to this requirement are those methods that by their inherent measurement principle may not need an inlet or separation device that segregates the aerosol; and
2.4.2.4 The ARM must be capable of providing for flow audits, unless by its inherent measurement principle, measured flow is not required. These flow audits are to be performed on the frequency identified in appendix A to this part.
2.4.2.5 If data transformations are used, they must be described in the monitoring agencies Quality Assurance Project plan (or addendum to QAPP). The QAPP shall describe how often (e.g., quarterly, yearly) and under what provisions the data transformation will be updated. For example, not meeting the data quality objectives for a site over a season or year may be cause for recalculating a data transformation, but by itself would not be cause for invalidating the data. Data transformations must be applied prospectively, i.e., in real-time or near real-time, to the data output from the PM2.5 continuous method. See reference 7 of this appendix.
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 Assessments of data quality shall follow the same frequencies and calculations as required under section 3 of appendix A to this part with the following exceptions:
2.4.4.1 Collocation of ARM with FRM/FEM samplers must be maintained at a minimum of 30 percent of the required SLAMS sites with a minimum of 1 per network;
2.4.4.2 All collocated FRM/FEM samplers must maintain a sample frequency of at least 1 in 6 sample days;
2.4.4.3 Collocated FRM/FEM samplers shall be located at the design value site, with the required FRM/FEM samplers deployed among the largest MSA/CSA in the network, until all required FRM/FEM are deployed; and
2.4.4.4 Data from collocated FRM/FEM are to be substituted for any calendar quarter that an ARM method has incomplete data.
2.4.4.5 Collocation with an ARM under this part for purposes of determining the coefficient of variation of the method shall be conducted at a minimum of 7.5 percent of the sites with a minimum of 1 per network. This is consistent with the requirements in appendix A to this part for one-half of the required collocation of FRM/FEM (15 percent) to be collocated with the same method.
2.4.4.6 Assessments of bias with an independent audit of the total measurement system shall be conducted with the same frequency as an FEM as identified in appendix A to this part.
2.4.5 Request for approval of a candidate ARM, that is not already approved in another agency's network under this section, must meet the general submittal requirements of section 2.7 of this appendix. Requests for approval under this section when an ARM is already approved in another agency's network are to be submitted to the EPA Regional Administrator. Requests for approval under section 2.4 of this appendix must include the following requirements:
2.4.5.1 A clear and unique description of the site(s) at which the candidate ARM 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.
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 AQS.
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 an ARM at a particular site or network of sites under section 2.4 of this appendix, the Administrator will approve or disapprove the method by letter to the person or agency requesting such approval. When appropriate for methods that are already approved in another SLAMS network, the EPA Regional Administrator has approval/disapproval authority. In either instance, additional information may be requested to assist with the decision.
2.5 [Reserved]
2.6 Use of Methods With Higher, Nonconforming Ranges in Certain Geographical Areas.
2.6.1 [Reserved]
2.6.2 An analyzer may be used (indefinitely) on a range which extends to concentrations higher than two times the upper limit specified in table B-1 of part 53 of this chapter if:
2.6.2.1 The analyzer has more than one selectable range and has been designated as a reference or equivalent method on at least one of its ranges, or has been approved for use under section 2.5 (which applies to analyzers purchased before February 18, 1975);
2.6.2.2 The pollutant intended to be measured with the analyzer is likely to occur in concentrations more than two times the upper range limit specified in table B-1 of part 53 of this chapter in the geographical area in which use of the analyzer is proposed; and
2.6.2.3 The Administrator determines that the resolution of the range or ranges for which approval is sought is adequate for its intended use. For purposes of this section (2.6), “resolution” means the ability of the analyzer to detect small changes in concentration.
2.6.3 Requests for approval under section 2.6.2 of this appendix must meet the submittal requirements of section 2.7. Except as provided in section 2.7.3 of this appendix, each request must contain the information specified in section 2.7.2 in addition to the following:
2.6.3.1 The range or ranges proposed to be used;
2.6.3.2 Test data, records, calculations, and test results as specified in section 2.7.2.2 of this appendix for each range proposed to be used;
2.6.3.3 An identification and description of the geographical area in which use of the analyzer is proposed;
2.6.3.4 Data or other information demonstrating that the pollutant intended to be measured with the analyzer is likely to occur in concentrations more than two times the upper range limit specified in table B-1 of part 53 of this chapter in the geographical area in which use of the analyzer is proposed; and
2.6.3.5 Test data or other information demonstrating the resolution of each proposed range that is broader than that permitted by section 2.5 of this appendix.
2.6.4 Any person who has obtained approval of a request under this section (2.6.2) shall assure that the analyzer for which approval was obtained is used only in the geographical area identified in the request and only while operated in the range or ranges specified in the request.
2.7 Requests for Approval; Withdrawal of Approval.
2.7.1 Requests for approval under sections 2.2, 2.4, 2.6.2, or 2.8 of this appendix must be submitted to: Director, National Exposure Research Laboratory Center for Environmental Measurement and Modeling, Reference and Equivalent Methods Designation Program (MD-D205-03), U.S. Environmental Protection Agency, P.O. Box 12055, Research Triangle Park, North Carolina 27711. For ARM that are already approved in another agency's network, subsequent requests for approval under section
4 are to be submitted to the applicable EPA Regional Administrator.2.
2.7.2 Except as provided in section 2.7.3 of this appendix, each request must contain:
2.7.2.1 A statement identifying the analyzer (e.g., by serial number) and the method of which the analyzer is representative (e.g., by manufacturer and model number); and
2.7.2.2 Test data, records, calculations, and test results for the analyzer (or the method of which the analyzer is representative) as specified in subpart B, subpart C, or both (as applicable) of part 53 of this chapter.
2.7.3 A request may concern more than one analyzer or geographical area and may incorporate by reference any data or other information known to EPA from one or more of the following:
2.7.3.1 An application for a reference or equivalent method determination submitted to EPA for the method of which the analyzer is representative, or testing conducted by the applicant or by EPA in connection with such an application;
2.7.3.2 Testing of the method of which the analyzer is representative at the initiative of the Administrator under § 53.7 of this chapter; or
2.7.3.3 A previous or concurrent request for approval submitted to EPA under this section (2.7).
2.7.4 To the extent that such incorporation by reference provides data or information required by this section (2.7) or by sections 2.4, 2.5, or 2.6 of this appendix, independent data or duplicative information need not be submitted.
2.7.5 After receiving a request under this section (2.7), the Administrator may request such additional testing or information or conduct such tests as may be necessary in his judgment for a decision on the request.
2.7.6 If the Administrator determines, on the basis of any available information, that any of the determinations or statements on which approval of a request under this section was based are invalid or no longer valid, or that the requirements of section 2.4, 2.5, or 2.6, as applicable, have not been met, he/she may withdraw the approval after affording the person who obtained the approval an opportunity to submit information and arguments opposing such action.
2.8 Modifications of Methods by Users.
2.8.1 Except as otherwise provided in this section, no reference method, equivalent method, or ARM may be used in a SLAMS network if it has been modified in a manner that could significantly alter the performance characteristics of the method without prior approval by the Administrator. For purposes of this section, “alternative method” means an analyzer, the use of which has been approved under section 2.4, 2.5, or 2.6 of this appendix or some combination thereof.
2.8.2 Requests for approval under this section (2.8) must meet the submittal requirements of sections 2.7.1 and 2.7.2.1 of this appendix.
2.8.3 Each request submitted under this section (2.8) must include:
2.8.3.1 A description, in such detail as may be appropriate, of the desired modification;
2.8.3.2 A brief statement of the purpose(s) of the modification, including any reasons for considering it necessary or advantageous;
2.8.3.3 A brief statement of belief concerning the extent to which the modification will or may affect the performance characteristics of the method; and
2.8.3.4 Such further information as may be necessary to explain and support the statements required by sections 2.8.3.2 and 2.8.3.3.
2.8.4 The Administrator will approve or disapprove the modification by letter to the person or agency requesting such approval within 75 days after receiving a request for approval under this section and any further information that the applicant may be asked to provide.
2.8.5 A temporary modification that could alter the performance characteristics of a reference, equivalent, or ARM may be made without prior approval under this section if the method is not functioning or is malfunctioning, provided that parts necessary for repair in accordance with the applicable operation manual cannot be obtained within 45 days. Unless such temporary modification is later approved under section 2.8.4 of this appendix, the temporarily modified method shall be repaired in accordance with the applicable operation manual as quickly as practicable but in no event later than 4 months after the temporary modification was made, unless an extension of time is granted by the Administrator. Unless and until the temporary modification is approved, air quality data obtained with the method as temporarily modified must be clearly identified as such when submitted in accordance with § 58.16 and must be accompanied by a report containing the information specified in section 2.8.3 of this appendix. A request that the Administrator approve a temporary modification may be submitted in accordance with sections 2.8.1 through 2.8.4 of this appendix. In such cases the request will be considered as if a request for prior approval had been made.
2.9 Use of IMPROVE Samplers at a SLAMS Site. “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. Descriptions of the IMPROVE samplers and the data they collect are available in references 4, 5, and 6 of this appendix.
2.10 Use of Pb-PM10at SLAMS Sites.
2.10.1 The EPA Regional Administrator may approve the use of a Pb-PM10 FRM or Pb-PM10 FEM sampler in lieu of a Pb-TSP sampler as part of the network plan required under part 58.10(a)(4) in the following cases.
2.10.1.1 Pb-PM10 samplers can be approved for use at the non-source-oriented sites required under paragraph 4.5(b) of Appendix D to part 58 if there is no existing monitoring data indicating that the maximum arithmetic 3-month mean Pb concentration (either Pb-TSP or Pb-PM10) at the site was equal to or greater than 0.10 micrograms per cubic meter during the previous 3 years.
2.10.1.2 Pb-PM10 samplers can be approved for use at source-oriented sites required under paragraph 4.5(a) if the monitoring agency can demonstrate (through modeling or historic monitoring data from the last 3 years) that Pb concentrations (either Pb-TSP or Pb-PM10) will not equal or exceed 0.10 micrograms per cubic meter on an arithmetic 3-month mean and the source is expected to emit a substantial majority of its Pb in the fraction of PM with an aerodynamic diameter of less than or equal to 10 micrometers.
2.10.2 The approval of a Pb-PM10 sampler in lieu of a Pb-TSP sampler as allowed for in paragraph 2.10.1 above will be revoked if measured Pb-PM10 concentrations equal or exceed 0.10 micrograms per cubic meter on an arithmetic 3-month mean. Monitoring agencies will have up to 6 months from the end of the 3-month period in which the arithmetic 3-month Pb-PM10 mean concentration equaled or exceeded 0.10 micrograms per cubic meter to install and begin operation of a Pb-TSP sampler at the site.
3.0 NCore Ncore Ambient Air Monitoring Stations
3.1 Methods employed in NCore Ncore multipollutant sites used to measure SO2, CO, NO2, O3, PM2.5, or PM10-2.5 must be reference or equivalent methods as defined in § 50.1 of this chapter, or an ARM as defined in section 2.4 of this appendix, for any monitors intended for comparison with applicable NAAQS.
3.2 If alternative SO2, CO, NO2, O3, PM2.5, or PM10-2.5 monitoring methodologies are proposed for monitors not intended for NAAQS comparison, such techniques must be detailed in the network description required by § 58.10 and subsequently approved by the Administrator. Examples of locations that are not intended to be compared to the NAAQS may be rural background and transport sites or areas where the concentration of the pollutant is so low that it would be more useful to operate a higher sensitivity method that is not an FRM or FEM.
4.0 Photochemical Assessment Monitoring Stations (PAMS)
4.1 Methods used for O3 monitoring at PAMS must be automated reference or equivalent methods as defined in § 50.1 of this chapter.
4.2 Methods used for NO, NO2 and NOX monitoring at PAMS should be automated reference or equivalent methods as defined for NO2 in § 50.1 of this chapter. If alternative NO, NO2 or NOX monitoring methodologies are proposed, such techniques must be detailed in the network description required by § 58.10 and subsequently approved by the Administrator.
4.3 Methods for meteorological measurements and speciated VOC monitoring are included in the guidance provided in references 2 and 3 of this appendix. If alternative VOC monitoring methodology (including the use of new or innovative technologies), which is not included in the guidance, is proposed, it must be detailed in the network description required by § 58.10 and subsequently approved by the Administrator.
5.0 Particulate Matter Episode Monitoring
5.1 For short-term measurements of PM10 during air pollution episodes (see § 51.152 of this chapter) the measurement method must be:
5.1.1 Either the “Staggered PM10” method or the “PM10 Sampling Over Short Sampling Times” method, both of which are based on the reference method for PM10 and are described in reference 1: or
5.1.2 Any other method for measuring PM10:
5.1.2.1 Which has a measurement range or ranges appropriate to accurately measure air pollution episode concentration of PM10,
5.1.2.2 Which has a sample period appropriate for short-term PM10 measurements, and
5.1.2.3 For which a quantitative relationship to a reference or equivalent method for PM10 has been established at the use site. Procedures for establishing a quantitative site-specific relationship are contained in reference 1.
5.2 PM10 methods other than the reference method are not covered under the quality assessment requirements of appendix to this part. Therefore, States must develop and implement their own quality assessment procedures for those methods allowed under this section 4. These quality assessment procedures should be similar or analogous to those described in section 3 of appendix A to this part for the PM10 reference method.
6.0 References
1. Pelton, D. J. Guideline for Particulate Episode Monitoring Methods, GEOMET Technologies, Inc., Rockville, MD. Prepared for U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Contract No. 68-02-3584. EPA 450/4-83-005. February 1983.
2. 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.
3. Quality Assurance Handbook for Air Pollution Measurement Systems: Volume IV. Meteorological Measurements. Atmospheric Research and Exposure Assessment Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. EPA 600/4-90-0003. August 1989.
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.
7. Data Quality Objectives (DQOs) for Relating Federal Reference Method (FRM) and Continuous PM2.5 Measurements to Report an Air Quality Index (AQI). Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. EPA 454/B-02-2002. November 2002.
[71 FR 61313, Oct. 17, 2006, as amended at 73 FR 67061, Nov. 12, 2008; 75 FR 6534, Feb. 9, 2010; 89 FR 16395, Mar. 6, 2024]