40 CFR § 75.21 - Quality assurance and quality control requirements.

§ 75.21 Quality assurance and quality control requirements.

(a) Continuous emission monitoring systems. The owner or operator of an affected unit shall operate, calibrate and maintain each continuous emission monitoring system used to report emission data under the Acid Rain Program as follows:

(1) The owner or operator shall operate, calibrate and maintain each primary and redundant backup continuous emission monitoring system according to the quality assurance and quality control procedures in appendix B of this part.

(2) The owner or operator shall ensure that each non-redundant backup CEMS meets the quality assurance requirements of § 75.20(d) for each day and quarter that the system is used to report data.

(3) The owner or operator shall perform quality assurance upon a reference method backup monitoring system according to the requirements of Method 2, 6C, 7E, or 3A in Appendices A-1, A-2 and A-4 to part 60 of this chapter (supplemented, as necessary, by guidance from the Administrator), instead of the procedures specified in appendix B to this part.

(4) The owner or operator of a unit with an SO2 continuous emission monitoring system is not required to perform the daily or quarterly assessments of the SO2 monitoring system under appendix B to this part on any day or in any calendar quarter in which only gaseous fuel is combusted in the unit if, during those days and calendar quarters, SO2 emissions are determined in accordance with § 75.11(e)(1). However, such assessments are permissible, and if any daily calibration error test or linearity test of the SO2 monitoring system is failed while the unit is combusting only gaseous fuel, the SO2 monitoring system shall be considered out-of-control. The length of the out-of-control period shall be determined in accordance with the applicable procedures in section 2.1.4 or 2.2.3 of appendix B to this part.

(5) For a unit with an SO2 continuous monitoring system, in which gaseous fuel that is very low sulfur fuel (as defined in § 72.2 of this chapter) is sometimes burned as a primary or backup fuel and in which higher-sulfur fuel(s) such as oil or coal are, at other times, burned as primary or backup fuel(s), the owner shall perform the relative accuracy test audits of the SO2 monitoring system (as required by section 6.5 of appendix A to this part and section 2.3.1 of appendix B to this part) only when the higher-sulfur fuel is combusted in the unit and shall not perform SO2 relative accuracy test audits when the very low sulfur gaseous fuel is the only fuel being combusted.

(6) If the designated representative certifies that a unit with an SO2 monitoring system burns only very low sulfur fuel (as defined in § 72.2 of this chapter), the SO2 monitoring system is exempted from the relative accuracy test audit requirements in appendices A and B to this part.

(7) If the designated representative certifies that a particular unit with an SO2 monitoring system combusts primarily fuel(s) that are very low sulfur fuel(s) (as defined in § 72.2 of this chapter) and combusts higher sulfur fuel(s) only for infrequent, non-routine operations (e.g., only as emergency backup fuel(s) or for short-term testing), the SO2 monitoring system shall be exempted from the RATA requirements of appendices A and B to this part in any calendar year that the unit combusts the higher sulfur fuel(s) for no more than 480 hours. If, in a particular calendar year, the higher-sulfur fuel usage exceeds 480 hours, the owner or operator shall perform a RATA of the SO2 monitor (while combusting the higher-sulfur fuel) either by the end of the calendar quarter in which the exceedance occurs or by the end of a 720 unit (or stack) operating hour grace period (under section 2.3.3 of appendix B to this part) following the quarter in which the exceedance occurs.

(8) The quality assurance provisions of §§ 75.11(e)(3)(i) through 75.11(e)(3)(iv) shall apply to all units with SO2 monitoring systems during hours in which only very low sulfur fuel (as defined in § 72.2 of this chapter) is combusted in the unit.

(9) Provided that a unit with an SO2 monitoring system is not exempted from the SO2 RATA requirements of this part under paragraphs (a)(6) or (a)(7) of this section, any calendar quarter during which a unit combusts only very low sulfur fuel (as defined in § 72.2 of this chapter) shall be excluded in determining the quarter in which the next relative accuracy test audit must be performed for the SO2 monitoring system. However, no more than eight successive calendar quarters shall elapse after a relative accuracy test audit of an SO2 monitoring system, without a subsequent relative accuracy test audit having been performed. The owner or operator shall ensure that a relative accuracy test audit is performed, in accordance with paragraph (a)(5) of this section, either by the end of the eighth successive elapsed calendar quarter since the last RATA or by the end of a 720 unit (or stack) operating hour grace period, as provided in section 2.3.3 of appendix B to this part.

(10) The owner or operator who, in accordance with § 75.11(e)(1), uses a certified flow monitor and a certified diluent monitor and Equation F-23 in appendix F to this part to calculate SO2 emissions during hours in which a unit combusts only natural gas or pipeline natural gas (as defined in § 72.2 of this chapter) shall meet all quality control and quality assurance requirements in appendix B to this part for the flow monitor and the diluent monitor.

(b) Continuous opacity monitoring systems. The owner or operator of an affected unit shall operate, calibrate, and maintain each continuous opacity monitoring system used under the Acid Rain Program according to the procedures specified for State Implementation Plans, pursuant to part 51, appendix M of this chapter.

(c) Calibration gases. The owner or operator shall ensure that all calibration gases used to quality assure the operation of the instrumentation required by this part shall meet the definition in § 72.2 of this chapter.

(d) Notification for periodic relative accuracy test audits. The owner or operator or the designated representative shall submit a written notice of the dates of relative accuracy testing as specified in § 75.61.

(e) Consequences of audits. The owner or operator shall invalidate data from a continuous emission monitoring system or continuous opacity monitoring system upon failure of an audit under appendix B to this part or any other audit, beginning with the unit operating hour of completion of a failed audit as determined by the Administrator. The owner or operator shall not use invalidated data for reporting either emissions or heat input, nor for calculating monitor data availability.

(1) Audit decertification. Whenever both an audit of a continuous emission or opacity monitoring system (or component thereof, including the data acquisition and handling system), of any excepted monitoring system under appendix D or E to this part, or of any alternative monitoring system under subpart E of this part, and a review of the initial certification application or of a recertification application, reveal that any system or component should not have been certified or recertified because it did not meet a particular performance specification or other requirement of this part, both at the time of the initial certification or recertification application submission and at the time of the audit, the Administrator will issue a notice of disapproval of the certification status of such system or component. For the purposes of this paragraph, an audit shall be either a field audit of the facility or an audit of any information submitted to EPA or the State agency regarding the facility. By issuing the notice of disapproval, the certification status is revoked prospectively by the Administrator. The data measured and recorded by each system shall not be considered valid quality-assured data from the date of issuance of the notification of the revoked certification status until the date and time that the owner or operator completes subsequently approved initial certification or recertification tests. The owner or operator shall follow the procedures in § 75.20(a)(5) for initial certification or § 75.20(b)(5) for recertification to replace, prospectively, all of the invalid, non-quality-assured data for each disapproved system.

(2) Out-of-control period. Whenever a continuous emission monitoring system or continuous opacity monitoring system fails a quality assurance audit or any other audit, the system is out-of-control. The owner or operator shall follow the procedures for out-of-control periods in § 75.24.

(f) Requirements for Air Emission Testing. On and after March 27, 2012, relative accuracy testing under § 75.74(c)(2)(ii), section 6.5 of appendix A to this part, and section 2.3.1 of appendix B to this part, and stack testing under § 75.19 and section 2.1 of appendix E to this part shall be performed by an “Air Emission Testing Body”, as defined in § 72.2 of this chapter. Conformance to the requirements of ASTM D7036-04 (incorporated by reference, see § 75.6), referred to in section 6.1.2 of appendix A to this part, shall apply only to these tests. Section 1.1.4 of appendix B to this part, and section 2.1 of appendix E to this part require compliance with section 6.1.2 of appendix A to this part. Tests and activities under this part not required to be performed by an AETB as defined in § 72.2 of this chapter include daily CEMS operation, daily calibration error checks, daily flow interference checks, quarterly linearity checks, routine maintenance of CEMS, voluntary emissions testing, or emissions testing required under other regulations.

(g) Requirements for EPA Protocol Gas Verification Program. Any EPA Protocol gas production site that chooses to participate in the EPA Protocol Gas Verification Program (PGVP) must notify the Administrator of its intent to participate. An EPA Protocol gas production site's participation shall commence immediately upon notification to EPA and shall extend through the end of the calendar year in which notification is provided. EPA will issue a vendor ID to each participating EPA Protocol gas production site. In each year of the PGVP, EPA may audit up to four EPA Protocol gas cylinders from each participating EPA Protocol gas production site.

(1) A production site participating in the PGVP shall provide the following information in its initial and ongoing notifications to EPA in an electronic format prescribed by the Administrator (see the CAMD Web site http://www.epa.gov/airmarkets/emissions/pgvp.html):

(i) The specialty gas company name which owns or operates the participating production site;

(ii) The name, e-mail address, and telephone number of a contact person for that specialty gas company;

(iii) The name and address of that participating EPA Protocol gas production site, owned or operated by the specialty gas company; and

(iv) The name, e-mail address, and telephone number of a contact person for that participating EPA Protocol gas production site.

(2) An EPA Protocol gas production site that elects to continue participating in the PGVP in the next calendar year must notify the Administrator of its intent to continue in the program by December 31 of the current year by submitting to EPA the information described in paragraph (g)(1) of this section.

(3) A list of the names, contact information, and vendor IDs of EPA Protocol gas production sites participating in the PGVP will be made publicly available by posting on EPA Web sites (see the CAMD Web site http://www.epa.gov/airmarkets/emissions/pgvp.html).

(4) EPA may remove an EPA Protocol gas production site from the list of PGVP participants and give notice to the production site for any of the following reasons:

(i) If the EPA Protocol gas production site fails to provide all of the information required by paragraph (g)(1) of this section in accordance with paragraph (g)(2) of this section;

(ii) If, after being notified that its EPA Protocol gas cylinders are being audited by EPA, the EPA Protocol gas production site fails to cancel its invoice or to credit the purchaser's account for the cylinders within 45 calendar days of such notification; or

(iii) If, after being notified that its EPA Protocol gas cylinders are being audited by EPA, the EPA Protocol gas production site cannot provide to EPA upon demand proof of payment to the National Institute of Standards and Technology (NIST) and a valid contract with NIST;

(5) EPA may relist an EPA Protocol gas production site as follows:

(i) An EPA Protocol gas production site may be relisted immediately after its failure is remedied if the only reason for removal from the list of PGVP participants is failure to provide all of the information required by paragraph (g)(1) of this section;

(ii) If EPA does not receive hardcopy or electronic proof of a credit receipt or of cancellation of the invoice for the cylinders from the EPA Protocol gas production site within 45 calendar days of notifying the EPA Protocol gas production site that its cylinders are being audited by EPA, the cylinders shall be returned to the EPA Protocol gas production site free of any demurrage, and that EPA Protocol gas production site shall not be eligible for relisting for 180 calendar days from the date of notice that it was removed from the list and until it submits to EPA the information required by paragraph (g)(1) of this section;

(iii) For any EPA Protocol gas production site which is notified by EPA that its cylinders are being audited and cannot provide to EPA upon demand proof of payment to NIST and a valid contract with NIST, the cylinders may either be kept by NIST or returned to the EPA Protocol gas production site free of any demurrage and at no cost to NIST, and that EPA Protocol gas production site shall not be eligible for relisting for 180 calendar days from the date of notice that it was removed from the list and until it submits to EPA the information required by paragraph (g)(1) of this section.

(6) On and after May 27, 2011 for each unit subject to this part that uses EPA Protocol gases, the owner or operator must obtain such gases from either an EPA Protocol gas production site that is on the EPA list of sites participating in the PGVP on the date the owner or operator procures such gases or from a reseller that sells to the owner or operator unaltered EPA Protocol gases produced by an EPA Protocol gas production site that was on the EPA list of participating sites on the date the reseller procured such gases.

(7) An EPA Protocol gas cylinder certified by or ordered from any non-participating EPA Protocol gas production site no later than May 27, 2011 may be used for the purposes of this part until the earlier of the cylinder's expiration date or the date on which the cylinder gas pressure reaches 150 psig. In the event that an EPA Protocol gas production site is removed from the list of PGVP participants on the same date as or after the date on which a particular cylinder has been certified or ordered, that gas cylinder may continue to be used for the purposes of this part until the earlier of the cylinder's expiration date or the date on which the cylinder gas pressure reaches 150 psig. However, in no case shall a cylinder described in this paragraph (g)(7) be recertified by a non-participating EPA Protocol gas production site to extend its useful life and be used by a source subject to this part.

(8) If EPA notifies a participating EPA Protocol gas production site that its EPA Protocol gas cylinders are being audited and identifies the purchaser as an EPA representative or contractor participating in the audit process, the production site shall:

(i) Either cancel that purchaser's invoice or credit that purchaser's account for the purchase of those EPA Protocol gas cylinders;

(ii) Not charge for demurrage for those EPA Protocol gas cylinders;

(iii) Arrange for and pay for the return shipment of its cylinders from NIST; and

(iv) Provide sufficient funding to NIST for:

(A) The analysis of those EPA Protocol gas cylinders by NIST;

(B) The production site's pro rata share of draft and final NIST electronic audit reports as specified in paragraphs (g)(9)(ii) through (g)(9)(v) of this section on all cylinders in the current audit; and

(C) The full cost of a draft redacted electronic audit report containing just that production site's results and the information as specified in paragraphs (g)(9)(ii) through (g)(9)(v) of this section;

(9) If EPA notifies a participating EPA Protocol gas production site that its EPA Protocol gas cylinders are being audited then:

(i) Each participating EPA Protocol gas production site must have NIST analyze its EPA Protocol gas cylinders provided for audit as soon after NIST receives the batch containing those cylinders as possible, preferably within two weeks of NIST's receipt, using analytical procedures consistent with metrology institute practices and at least as rigorous as the “EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards” (Traceability Protocol), September 1997, as amended August 25, 1999, EPA-600/R-97/121, (incorporated by reference, see § 75.6) or equivalent written cylinder analysis protocol that has been approved by EPA.

(ii) Each cylinder's concentration must be determined by NIST and the results compared to each cylinder's certification documentation and tag value to establish conformance with section 5.1 of appendix A to this part. After NIST analysis, each cylinder must be provided with a NIST analyzed concentration with an expanded uncertainty, as defined in § 72.2, (coverage factor, as defined in § 72.2, k = 2) of plus or minus 1.0 percent (calculated combined standard uncertainty of plus or minus 0.5%), inclusive, or better, unless otherwise approved by EPA.

(iii) The certification documentation accompanying each cylinder must be verified in the audit report as meeting the requirements of “EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards,” September 1997, as amended August 25, 1999, EPA-600/R-97/121 (incorporated by reference, see § 75.6) or a revised procedure approved by the Administrator.

(iv) Each participating EPA Protocol gas production site shall have NIST provide all of the information required by paragraphs (g)(9)(ii) through (g)(9)(v) of this section in draft and final electronic audit reports on all cylinders in the current audit, and in a draft redacted electronic audit report containing just that production site's information. The draft audit report on all cylinders in the current audit and each draft redacted version of the audit report shall be submitted electronically by NIST to pgvp@epa.gov, unless otherwise provided by the Administrator, within four weeks of completion of all cylinder analyses or as soon as possible thereafter. The draft and final audit report on all cylinders in the current audit shall only be sent to EPA. EPA will send the applicable draft redacted audit report to each participating production site for comment. To be considered in the final posted audit report, EPA must receive comments, and any cylinder re-analyses from participating EPA Protocol gas production sites within 60 days of the participating EPA Protocol gas production site's receipt of the draft redacted audit report. All comments from production sites, including any cylinder re-analyses, on the draft redacted versions of the audit report shall be submitted electronically to pgvp@epa.gov, unless otherwise provided by the Administrator. The final audit report on all cylinders in the current audit shall be submitted electronically by NIST to pgvp@epa.gov, unless otherwise provided by the Administrator, within 90 days of the participating EPA Protocol gas production site's receipt of the draft redacted audit report sent by EPA or as soon as possible thereafter. EPA will post the final results of the NIST analyses on EPA Web sites (see the CAMD Web site http://www.epa.gov/airmarkets/emissions/pgvp.html). Each audit report shall include:

(A) A table with the information and in the format specified by Figure 3 (or the Note below Figure 3, as applicable) of appendix B to this part or such revised format as approved by the Administrator; and

(B) Complete documentation of the NIST procedures used to analyze the cylinders, including the analytical reference standards, analytical method, analytical method uncertainty, analytical instrumentation, and instrument calibration procedures.

(v) For EPA Protocol gas production sites that produce EPA Protocol gas cylinders claiming NIST traceability for both NO and NOX concentrations in the same cylinder, if analyzed by NIST for the PGVP, such cylinders must be analyzed by NIST for both the NO and NOX components (where total NOX is determined by NO plus NO2) and the results of the analyses shall be included in the audit report.

(10) An EPA Protocol gas production site shall continue to be on the EPA list of sites participating in the PGVP and may continue to sell EPA Protocol gases to sources subject to part 75 if it is not notified by EPA that its cylinders are being audited under the PGVP if it provides the information described in paragraph (g)(1) of this section in accordance with paragraph (g)(2) of this section.

(11) The data validation procedures under §§ 2.1.4, 2.2.3, and 2.3.2 of appendix B to this part apply.

[58 FR 3701, Jan. 11, 1993, as amended at 60 FR 26527, 26566, May 17, 1995; 61 FR 25582, May 22, 1996; 61 FR 59159, Nov. 20, 1996; 64 FR 28599, May 26, 1999; 67 FR 40433, June 12, 2002; 67 FR 53505, Aug. 16, 2002; 70 FR 28679, May 18, 2005; 73 FR 4345, Jan. 24, 2008; 76 FR 17308, Mar. 28, 2011]

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