Title 40—Protection of Environment--Volume 1
PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES
§ 63.344   Performance test requirements and test methods.
(a) Performance test requirements. Performance tests shall be conducted using the test methods and procedures in this section. Performance tests shall be conducted under such conditions as the Administrator specifies to the owner or operator based on representative performance of the affected source for the period being tested. Upon request, the owner or operator shall make available to the Administrator such records as may be necessary to determine the conditions of performance tests. Performance test results shall be documented in complete test reports that contain the information required by paragraphs (a)(1) through (9) of this section. The test plan to be followed shall be made available to the Administrator prior to the testing, if requested.
(1) A brief process description;
(2) Sampling location description(s);
(3) A description of sampling and analytical procedures and any modifications to standard procedures;
(4) Test results;
(5) Quality assurance procedures and results;
(6) Records of operating conditions during the test, preparation of standards, and calibration procedures;
(7) Raw data sheets for field sampling and field and laboratory analyses;
(8) Documentation of calculations; and
(9) Any other information required by the test method.
(b)(1) If the owner or operator of an affected source conducts performance testing at startup to obtain an operating permit in the State in which the affected source is located, the results of such testing may be used to demonstrate compliance with this subpart if:
(i) The test methods and procedures identified in paragraph (c) of this section were used during the performance test;
(ii) The performance test was conducted under representative operating conditions for the source;
(iii) The performance test report contains the elements required by paragraph (a) of this section;
(iv) The owner or operator of the affected source for which the performance test was conducted has sufficient data to establish the operating parameter value(s) that correspond to compliance with the standards, as required for continuous compliance monitoring under § 63.343(c);
(v) The performance test was conducted after January 25, 1995;
(vi) As of September 19, 2012 the source was using the same emissions controls that were used during the compliance test;
(vii) As of September 19, 2012, the source was operating under conditions that are representative of the conditions under which the source was operating during the compliance test; and
(viii) Based on approval from the permitting authority.
(2) [Reserved]
(c) Test methods. Each owner or operator subject to the provisions of this subpart and required by § 63.343(b) to conduct an initial performance test shall use the test methods identified in this section to demonstrate compliance with the standards in § 63.342.
(1) Method 306 or Method 306A, “Determination of Chromium Emissions From Decorative and Hard Chromium Electroplating and Anodizing Operations,” appendix A of this part shall be used to determine the chromium concentration from hard or decorative chromium electroplating tanks or chromium anodizing tanks. The sampling time and sample volume for each run of Methods 306 and 306A, appendix A of this part shall be at least 120 minutes and 1.70 dscm (60 dscf), respectively. Methods 306 and 306A, appendix A of this part allow the measurement of either total chromium or hexavalent chromium emissions. For the purposes of this standard, sources using chromic acid baths must demonstrate compliance with the emission limits of § 63.342 by measuring the total chromium.
(2) The California Air Resources Board (CARB) Method 425 (which is available by contacting the California Air Resources Board, 1102 Q Street, Sacramento, California 95814) may be used to determine the chromium concentration from hard and decorative chromium electroplating tanks and chromium anodizing tanks if the following conditions are met:
(i) If a colorimetric analysis method is used, the sampling time and volume shall be sufficient to result in 33 to 66 micrograms of catch in the sampling train.
(ii) If Atomic Absorption Graphite Furnace (AAGF) or Ion Chromatography with a Post-column Reactor (ICPCR) analyses were used, the sampling time and volume should be sufficient to result in a sample catch that is 5 to 10 times the minimum detection limit of the analytical method (i.e., 1.0 microgram per liter of sample for AAGF and 0.5 microgram per liter of sample for ICPCR).
(iii) In the case of either paragraph (c)(2) (i) or (ii) of this section, a minimum of 3 separate runs must be conducted. The other requirements of § 63.7 that apply to affected sources, as indicated in Table 1 of this subpart, must also be met.
(3) Method 306B, “Surface Tension Measurement and Recordkeeping for Tanks Used at Decorative Chromium Electroplating and Anodizing Facilities,” appendix A of this part shall be used to measure the surface tension of electroplating and anodizing baths.
(4) Alternate test methods may also be used if the method has been validated using Method 301, appendix A of this part and if approved by the Administrator. Procedures for requesting and obtaining approval are contained in § 63.7(f).
(5) The South Coast Air Quality Management District (SCAQMD) Method 205.1 (which is available by contacting the South Coast AQMD, 21865 Copley Dr, Diamond Bar, CA 91765) may be used to determine the total chromium concentration from hard and decorative chromium electroplating tanks and chromium anodizing tanks.
(d) Establishing site-specific operating parameter values. (1) Each owner or operator required to establish site-specific operating parameters shall follow the procedures in this section.
(2) All monitoring equipment shall be installed such that representative measurements of emissions or process parameters from the affected source are obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the monitoring equipment shall include execution of the manufacturer's written specifications or recommendations for installation, operation, and calibration of the system.
(i) Specifications for differential pressure measurement devices used to measure velocity pressure shall be in accordance with section 2.2 of Method 2 (40 CFR part 60, appendix A).
(ii) Specification for differential pressure measurement devices used to measure pressure drop across a control system shall be in accordance with manufacturer's accuracy specifications.
(3) The surface tension of electroplating and anodizing baths shall be measured using Method 306B, “Surface Tension Measurement and Recordkeeping for Tanks used at Decorative Chromium Electroplating and Anodizing Facilities,” appendix A of this part. This method should also be followed when wetting agent type or combination wetting agent/foam blanket type fume suppressants are used to control chromium emissions from a hard chromium electroplating tank and surface tension measurement is conducted to demonstrate continuous compliance.
(4) The owner or operator of a source required to measure the velocity pressure at the inlet to an add-on air pollution control device in accordance with § 63.343(c)(2), shall establish the site-specific velocity pressure as follows:
(i) Locate a velocity traverse port in a section of straight duct that connects the hooding on the plating tank or tanks with the control device. The port shall be located as close to the control system as possible, and shall be placed a minimum of 2 duct diameters downstream and 0.5 diameter upstream of any flow disturbance such as a bend, expansion, or contraction (see Method 1, 40 CFR part 60, appendix A). If 2.5 diameters of straight duct work does not exist, locate the port 0.8 of the duct diameter downstream and 0.2 of the duct diameter upstream from any flow disturbance.
(ii) A 12-point velocity traverse of the duct to the control device shall be conducted along a single axis according to Method 2 (40 CFR part 60, appendix A) using an S-type pitot tube; measurement of the barometric pressure and duct temperature at each traverse point is not required, but is suggested. Mark the S-type pitot tube as specified in Method 1 (40 CFR part 60, appendix A) with 12 points. Measure the velocity pressure (Δ p) values for the velocity points and record. Determine the square root of the individual velocity point Δ p values and average. The point with the square root value that comes closest to the average square root value is the point of average velocity. The Δ p value measured for this point during the performance test will be used as the reference for future monitoring.
(5) The owner or operator of a source required to measure the pressure drop across the add-on air pollution control device in accordance with § 63.343(c) (1) through (4) may establish the pressure drop in accordance with the following guidelines:
(i) Pressure taps shall be installed at any of the following locations:
(A) At the inlet and outlet of the control system. The inlet tap should be installed in the ductwork just prior to the control device and the corresponding outlet pressure tap should be installed on the outlet side of the control device prior to the blower or on the downstream side of the blower;
(B) On each side of the packed bed within the control system or on each side of each mesh pad within the control system; or
(C) On the front side of the first mesh pad and back side of the last mesh pad within the control system.
(ii) Pressure taps shall be sited at locations that are:
(A) Free from pluggage as possible and away from any flow disturbances such as cyclonic demisters.
(B) Situated such that no air infiltration at measurement site will occur that could bias the measurement.
(iii) Pressure taps shall be constructed of either polyethylene, polybutylene, or other nonreactive materials.
(iv) Nonreactive plastic tubing shall be used to connect the pressure taps to the device used to measure pressure drop.
(v) Any of the following pressure gauges can be used to monitor pressure drop: a magnehelic gauge, an inclined manometer, or a “U” tube manometer.
(vi) Prior to connecting any pressure lines to the pressure gauge(s), each gauge should be zeroed. No calibration of the pressure gauges is required.
(e) Special compliance provisions for multiple sources controlled by a common add-on air pollution control device. (1) This section identifies procedures for measuring the outlet chromium concentration from an add-on air pollution control device that is used to control multiple sources that may or may not include sources not affected by this subpart.
(2) When multiple affected sources performing the same type of operation (e.g., all are performing hard chromium electroplating), and subject to the same emission limitation, are controlled with an add-on air pollution control device that is not controlling emissions from any other type of affected operation or from any nonaffected sources, the applicable emission limitation identified in § 63.342 must be met at the outlet of the add-on air pollution control device.
(3) When multiple affected sources performing the same type of operation and subject to the same emission limitation are controlled with a common add-on air pollution control device that is also controlling emissions from sources not affected by these standards, the following procedures should be followed to determine compliance with the applicable emission limitation in § 63.342:
(i) Calculate the cross-sectional area of each inlet duct (i.e., uptakes from each hood) including those not affected by the standard.
(ii) Determine the total sample time per test run by dividing the total inlet area from all tanks connected to the control system by the total inlet area for all ducts associated with affected sources, and then multiply this number by 2 hours. The calculated time is the minimum sample time required per test run.
(iii) Perform Method 306 or 306A testing and calculate an outlet mass emission rate.
(iv) Determine the total ventilation rate from the affected sources (VR inlet ) by using equation 1:
(v) Establish the allowable mass emission rate of the system (AMR sys ) in milligrams of total chromium per hour (mg/hr) using equation 2:
(4) When multiple affected sources performing different types of operations (e.g., hard chromium electroplating, decorative chromium electroplating, or chromium anodizing) are controlled by a common add-on air pollution control device that may or may not also be controlling emissions from sources not affected by these standards, or if the affected sources controlled by the common add-on air pollution control device perform the same operation but are subject to different emission limitations (e.g., because one is a new hard chromium plating tank and one is an existing small, hard chromium plating tank), the following procedures should be followed to determine compliance with the applicable emission limitation in § 63.342:
(i) Follow the steps outlined in paragraphs (e)(3)(i) through (e)(3)(iii) of this section.
(ii) Determine the total ventilation rate for each type of affected source (VR inlet ,a) using equation 3:
(iii) Establish the allowable mass emission rate in mg/hr for each type of affected source that is controlled by the add-on air pollution control device using equation 4, 5, 6, or 7 as appropriate:
(iv) Establish the allowable mass emission rate of the system (AMR sys ) in milligrams of total chromium per hour (mg/hr) using equation 8, including each type of affected source as appropriate:
The allowable mass emission rate calculated from equation 8 should be equal to or more than the outlet three-run average mass emission rate determined from Method 306 or 306A testing in order for the source to be in compliance with the standards.
(5) Each owner or operator that uses the special compliance provisions of this paragraph to demonstrate compliance with the emission limitations of § 63.342 shall submit the measurements and calculations to support these compliance methods with the notification of compliance status required by § 63.347(e).
(6) Each owner or operator that uses the special compliance provisions of this section to demonstrate compliance with the emission limitations of § 63.342 shall repeat these procedures if a tank is added or removed from the control system regardless of whether that tank is a nonaffected source. If the new nonaffected tank replaces an existing nonaffected tank of the same size and is connected to the control system through the same size inlet duct then this procedure does not have to be repeated.
(f) Compliance provisions for the mass rate emission standard for enclosed hard chromium electroplating tanks. (1) This section identifies procedures for calculating the maximum allowable mass emission rate for owners or operators of affected sources who choose to meet the mass emission rate standard in § 63.342(c)(2)(iv) or (v).
(i)(A) The owner or operator of an enclosed hard chromium electroplating tank that is an existing affected source and is located at a large hard chromium electroplating facility who chooses to meet the mass emission rate standard in § 63.342(c)(2)(iv) shall determine compliance by not allowing the mass rate of total chromium in the exhaust gas stream discharged to the atmosphere to exceed the maximum allowable mass emission rate calculated using equation 9:
(B) Compliance with the alternative mass emission limit is demonstrated if the three-run average mass emission rate determined from Method 306 testing is less than or equal to the maximum allowable mass emission rate calculated from equation 9.
(ii)(A) The owner or operator of an enclosed hard chromium electroplating tank that is an existing affected source located at a small hard chromium electroplating facility who chooses to meet the mass emission rate standard in § 63.342(c)(2)(v) shall determine compliance by not allowing the mass rate of total chromium in the exhaust gas stream discharged to the atmosphere to exceed the maximum allowable mass emission rate calculated using equation 10:
(B) Compliance with the alternative mass emission limit is demonstrated if the three-run average mass emission rate determined from testing using Method 306 of appendix A to part 63 is less than or equal to the maximum allowable mass emission rate calculated from equation 10.
(iii)(A) The owner or operator of an enclosed hard chromium electroplating tank that is a new source who chooses to meet the mass emission rate standard in § 63.342(c)(2)(vii) shall determine compliance by not allowing the mass rate of total chromium in the exhaust gas stream discharged to the atmosphere to exceed the maximum allowable mass emission rate calculated using equation 11:
(B) Compliance with the alternative mass emission limit is demonstrated if the three-run average mass emission rate determined from testing using Method 306 or 306A of appendix A to part 63 is less than or equal to the maximum allowable mass emission rate calculated from equation 11.
§ 63.345   Provisions for new and reconstructed sources.
(a) This section identifies the preconstruction review requirements for new and reconstructed affected sources that are subject to, or become subject to, this subpart.
(b) New or reconstructed affected sources. The owner or operator of a new or reconstructed affected source is subject to § 63.5(a), (b)(1), (b)(5), (b)(6), and (f)(1), as well as the provisions of this paragraph.
(1) After January 25, 1995, whether or not an approved permit program is effective in the State in which an affected source is (or would be) located, no person may construct a new affected source or reconstruct an affected source subject to this subpart, or reconstruct a source such that it becomes an affected source subject to this subpart, without submitting a notification of construction or reconstruction to the Administrator. The notification shall contain the information identified in paragraphs (b) (2) and (3) of this section, as appropriate.
(2) The notification of construction or reconstruction required under paragraph (b)(1) of this section shall include:
(i) The owner or operator's name, title, and address;
(ii) The address (i.e., physical location) or proposed address of the affected source if different from the owner's or operator's;
(iii) A notification of intention to construct a new affected source or make any physical or operational changes to an affected source that may meet or has been determined to meet the criteria for a reconstruction as defined in § 63.2;
(iv) An identification of subpart N of this part as the basis for the notification;
(v) The expected commencement and completion dates of the construction or reconstruction;
(vi) The anticipated date of (initial) startup of the affected source;
(vii) The type of process operation to be performed (hard or decorative chromium electroplating, or chromium anodizing);
(viii) A description of the air pollution control technique to be used to control emissions from the affected source, such as preliminary design drawings and design capacity if an add-on air pollution control device is used; and
(ix) An estimate of emissions from the source based on engineering calculations and vendor information on control device efficiency, expressed in units consistent with the emission limits of this subpart. Calculations of emission estimates should be in sufficient detail to permit assessment of the validity of the calculations.
(3) If a reconstruction is to occur, the notification required under paragraph (b)(1) of this section shall include the following in addition to the information required in paragraph (b)(2) of this section:
(i) A brief description of the affected source and the components to be replaced;
(ii) A brief description of the present and proposed emission control technique, including the information required by paragraphs (b)(2) (viii) and (ix) of this section;
(iii) An estimate of the fixed capital cost of the replacements and of constructing a comparable entirely new source;
(iv) The estimated life of the affected source after the replacements; and
(v) A discussion of any economic or technical limitations the source may have in complying with relevant standards or other requirements after the proposed replacements. The discussion shall be sufficiently detailed to demonstrate to the Administrator's satisfaction that the technical or economic limitations affect the source's ability to comply with the relevant standard and how they do so.
(vi) If in the notification of reconstruction, the owner or operator designates the affected source as a reconstructed source and declares that there are no economic or technical limitations to prevent the source from complying with all relevant standards or requirements, the owner or operator need not submit the information required in paragraphs (b)(3) (iii) through (v) of this section.
(4) The owner or operator of a new or reconstructed affected source that submits a notification in accordance with paragraphs (b) (1) through (3) of this section is not subject to approval by the Administrator. Construction or reconstruction is subject only to notification and can begin upon submission of a complete notification.
(5) Submittal timeframes. After January 25, 1995, whether or not an approved permit program is effective in the State in which an affected source is (or would be) located, an owner or operator of a new or reconstructed affected source shall submit the notification of construction or reconstruction required by paragraph (b)(1) of this section according to the following schedule:
(i) If construction or reconstruction commences after January 25, 1995, the notification shall be submitted as soon as practicable before the construction or reconstruction is planned to commence.
(ii) If the construction or reconstruction had commenced and initial startup had not occurred before January 25, 1995, the notification shall be submitted as soon as practicable before startup but no later than 60 days after January 25, 1995.
§ 63.346   Recordkeeping requirements.
(a) The owner or operator of each affected source subject to these standards shall fulfill all recordkeeping requirements outlined in this section and in the General Provisions to 40 CFR part 63, according to the applicability of subpart A of this part as identified in Table 1 of this subpart.
(b) The owner or operator of an affected source subject to the provisions of this subpart shall maintain the following records for such source:
(1) Inspection records for the add-on air pollution control device, if such a device is used, and monitoring equipment, to document that the inspection and maintenance required by the work practice standards of § 63.342(f) and Table 1 of § 63.342 have taken place. The record can take the form of a checklist and should identify the device inspected, the date of inspection, a brief description of the working condition of the device during the inspection, and any actions taken to correct deficiencies found during the inspection.
(2) Records of all maintenance performed on the affected source, the add-on air pollution control device, and monitoring equipment, except routine housekeeping practices;
(3) Records of the occurrence, duration, and cause (if known) of each malfunction of process, add-on air pollution control, and monitoring equipment;
(4) Records of actions taken during periods of malfunction to minimize emissions in accordance with § 63.342(a)(1), including corrective actions to restore malfunctioning process and air pollution control and monitoring equipment to its normal or usual manner of operation;
(5) Other records, which may take the form of checklists, necessary to demonstrate consistency with the provisions of the operation and maintenance plan required by § 63.342(f)(3);
(6) Test reports documenting results of all performance tests;
(7) All measurements as may be necessary to determine the conditions of performance tests, including measurements necessary to determine compliance with the special compliance procedures of § 63.344(e);
(8) Records of monitoring data required by § 63.343(c) that are used to demonstrate compliance with the standard including the date and time the data are collected;
(9) The specific identification (i.e., the date and time of commencement and completion) of each period of excess emissions, as indicated by monitoring data, that occurs during malfunction of the process, add-on air pollution control, or monitoring equipment;
(10) The specific identification (i.e., the date and time of commencement and completion) of each period of excess emissions, as indicated by monitoring data, that occurs during periods other than malfunction of the process, add-on air pollution control, or monitoring equipment;
(11) The total process operating time of the affected source during the reporting period;
(12) Records of the actual cumulative rectifier capacity of hard chromium electroplating tanks at a facility expended during each month of the reporting period, and the total capacity expended to date for a reporting period, if the owner or operator is using the actual cumulative rectifier capacity to determine facility size in accordance with § 63.342(c)(2);
(13) For sources using fume suppressants to comply with the standards, records of the date and time that fume suppressants are added to the electroplating or anodizing bath and records of the fume suppressant manufacturer and product name;
(14) For sources complying with § 63.342(e), records of the bath components purchased, with the wetting agent clearly identified as a bath constituent contained in one of the components;
(15) Any information demonstrating whether a source is meeting the requirements for a waiver of recordkeeping or reporting requirements, if the source has been granted a waiver under § 63.10(f); and
(16) All documentation supporting the notifications and reports required by § 63.9, § 63.10, and § 63.347.
(c) All records shall be maintained for a period of 5 years in accordance with § 63.10(b)(1).
§ 63.347   Reporting requirements.
(a) The owner or operator of each affected source subject to these standards shall fulfill all reporting requirements outlined in this section and in the General Provisions to 40 CFR part 63, according to the applicability of subpart A as identified in Table 1 of this subpart. These reports shall be made to the Administrator at the appropriate address as identified in § 63.13 or to the delegated State authority.
(1) Reports required by subpart A of this part and this section may be sent by U.S. mail, fax, or by another courier.
(i) Submittals sent by U.S. mail shall be postmarked on or before the specified date.
(ii) Submittals sent by other methods shall be received by the Administrator on or before the specified date.
(2) If acceptable to both the Administrator and the owner or operator of an affected source, reports may be submitted on electronic media.
(b) The reporting requirements of this section apply to the owner or operator of an affected source when such source becomes subject to the provisions of this subpart.
(c) Initial notifications. (1) The owner or operator of an affected source that has an initial startup before January 25, 1995, shall notify the Administrator in writing that the source is subject to this subpart. The notification shall be submitted no later than 180 calendar days after January 25, 1995, or no later than 120 days after the source becomes subject to this subpart, whichever is later, and shall contain the following information:
(i) The name, title, and address of the owner or operator;
(ii) The address (i.e., physical location) of each affected source;
(iii) A statement that subpart N of this part is the basis for this notification;
(iv) Identification of the applicable emission limitation and compliance date for each affected source;
(v) A brief description of each affected source, including the type of process operation performed;
(vi) For sources performing hard chromium electroplating, the maximum potential cumulative potential rectifier capacity;
(vii) For sources performing hard chromium electroplating, a statement of whether the affected source(s) is located at a small or a large, hard chromium electroplating facility and whether this will be demonstrated through actual or maximum potential cumulative rectifier capacity;
(viii) For sources performing hard chromium electroplating, a statement of whether the owner or operator of an affected source(s) will limit the maximum potential cumulative rectifier capacity in accordance with § 63.342(c)(2) such that the hard chromium electroplating facility is considered small; and
(ix) A statement of whether the affected source is located at a major source or an area source as defined in § 63.2.
(2) The owner or operator of a new or reconstructed affected source that has an initial startup after January 25, 1995 shall submit an initial notification (in addition to the notification of construction or reconstruction required by § 63.345(b) as follows:
(i) A notification of the date when construction or reconstruction was commenced, shall be submitted simultaneously with the notification of construction or reconstruction, if construction or reconstruction was commenced before January 25, 1995;
(ii) A notification of the date when construction or reconstruction was commenced, shall be submitted no later than 30 calendar days after such date, if construction or reconstruction was commenced after January 25, 1995; and
(iii) A notification of the actual date of startup of the source shall be submitted within 30 calendar days after such date.
(d) Notification of performance test. (1) The owner or operator of an affected source shall notify the Administrator in writing of his or her intention to conduct a performance test at least 60 calendar days before the test is scheduled to begin to allow the Administrator to have an observer present during the test. Observation of the performance test by the Administrator is optional.
(2) In the event the owner or operator is unable to conduct the performance test as scheduled, the provisions of § 63.7(b)(2) apply.
(e) Notification of compliance status. (1) A notification of compliance status is required each time that an affected source becomes subject to the requirements of this subpart.
(2) If the State in which the source is located has not been delegated the authority to implement the rule, each time a notification of compliance status is required under this part, the owner or operator of an affected source shall submit to the Administrator a notification of compliance status, signed by the responsible official (as defined in § 63.2) who shall certify its accuracy, attesting to whether the affected source has complied with this subpart. If the State has been delegated the authority, the notification of compliance status shall be submitted to the appropriate authority. The notification shall list for each affected source:
(i) The applicable emission limitation and the methods that were used to determine compliance with this limitation;
(ii) If a performance test is required by this subpart, the test report documenting the results of the performance test, which contains the elements required by § 63.344(a), including measurements and calculations to support the special compliance provisions of § 63.344(e) if these are being followed;
(iii) The type and quantity of hazardous air pollutants emitted by the source reported in mg/dscm or mg/hr if the source is using the special provisions of § 63.344(e) to comply with the standards. (If the owner or operator is subject to the construction and reconstruction provisions of § 63.345 and had previously submitted emission estimates, the owner or operator shall state that this report corrects or verifies the previous estimate.) For sources not required to conduct a performance test in accordance with § 63.343(b), the surface tension measurement may fulfill this requirement;
(iv) For each monitored parameter for which a compliant value is to be established under § 63.343(c), the specific operating parameter value, or range of values, that corresponds to compliance with the applicable emission limit;
(v) The methods that will be used to determine continuous compliance, including a description of monitoring and reporting requirements, if methods differ from those identified in this subpart;
(vi) A description of the air pollution control technique for each emission point;
(vii) A statement that the owner or operator has completed and has on file the operation and maintenance plan as required by the work practice standards in § 63.342(f);
(viii) If the owner or operator is determining facility size based on actual cumulative rectifier capacity in accordance with § 63.342(c)(2), records to support that the facility is small. For existing sources, records from any 12-month period preceding the compliance date shall be used or a description of how operations will change to meet a small designation shall be provided. For new sources, records of projected rectifier capacity for the first 12-month period of tank operation shall be used;
(ix) A statement by the owner or operator of the affected source as to whether the source has complied with the provisions of this subpart.
(3) For sources required to conduct a performance test by § 63.343(b), the notification of compliance status shall be submitted to the Administrator no later than 90 calendar days following completion of the compliance demonstration required by § 63.7 and § 63.343(b).
(4) For sources that are not required to complete a performance test in accordance with § 63.343(b), the notification of compliance status shall be submitted to the Administrator no later than 30 days after the compliance date specified in § 63.343(a), except the date on which sources in California shall monitor the surface tension of the anodizing bath is extended to January 25, 1998.
(f) Reports of performance test results. (1) If the State in which the source is located has not been delegated the authority to implement the rule, the owner or operator of an affected source shall report to the Administrator the results of any performance test conducted as required by § 63.7 or § 63.343(b). If the State has been delegated the authority, the owner or operator of an affected source should report performance test results to the appropriate authority.
(2) Reports of performance test results shall be submitted no later than 90 days following the completion of the performance test, and shall be submitted as part of the notification of compliance status required by paragraph (e) of this section.
(3)(i) Within 60 days after the date of completing each performance test (defined in § 63.2) as required by this subpart, you must submit the results of the performance tests, including any associated fuel analyses, required by this subpart to the EPA's WebFIRE database by using the Compliance and Emissions Data Reporting Interface (CEDRI) that is accessed through the EPA's Central Data Exchange (CDX) ( www.epa.gov/cdx ). Performance test data must be submitted in the file format generated through use of the EPA's Electronic Reporting Tool (ERT) (see http://www.epa.gov/ttn/chief/ert/index.html ). Only data collected using test methods on the ERT Web site are subject to this requirement for submitting reports electronically to WebFIRE. Owners or operators who claim that some of the information being submitted for performance tests is confidential business information (CBI) must submit a complete ERT file including information claimed to be CBI on a compact disk, flash drive or other commonly used electronic storage media to the EPA. The electronic media must be clearly marked as CBI and mailed to U.S. EPA/OAPQS/CORE CBI Office, Attention: WebFIRE Administrator, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same ERT file with the CBI omitted must be submitted to the EPA via CDX as described earlier in this paragraph. At the discretion of the delegated authority, you must also submit these reports, including the confidential business information, to the delegated authority in the format specified by the delegated authority. For any performance test conducted using test methods that are not listed on the ERT Web site, the owner or operator shall submit the results of the performance test to the Administrator at the appropriate address listed in § 63.13.
(g) Ongoing compliance status reports for major sources. (1) The owner or operator of an affected source that is located at a major source site shall submit a summary report to the Administrator to document the ongoing compliance status of the affected source. The report shall contain the information identified in paragraph (g)(3) of this section, and shall be submitted semiannually except when:
(i) The Administrator determines on a case-by-case basis that more frequent reporting is necessary to accurately assess the compliance status of the source; or
(ii) The monitoring data collected by the owner or operator of the affected source in accordance with § 63.343(c) show that the emission limit has been exceeded, in which case quarterly reports shall be submitted. Once an owner or operator of an affected source reports an exceedance, ongoing compliance status reports shall be submitted quarterly until a request to reduce reporting frequency under paragraph (g)(2) of this section is approved.
(2) Request to reduce frequency of ongoing compliance status reports. (i) An owner or operator who is required to submit ongoing compliance status reports on a quarterly (or more frequent basis) may reduce the frequency of reporting to semiannual if all of the following conditions are met:
(A) For 1 full year (e.g., 4 quarterly or 12 monthly reporting periods), the ongoing compliance status reports demonstrate that the affected source is in compliance with the relevant emission limit;
(B) The owner or operator continues to comply with all applicable recordkeeping and monitoring requirements of subpart A of this part and this subpart; and
(C) The Administrator does not object to a reduced reporting frequency for the affected source, as provided in paragraphs (g)(2) (ii) and (iii) of this section.
(ii) The frequency of submitting ongoing compliance status reports may be reduced only after the owner or operator notifies the Administrator in writing of his or her intention to make such a change, and the Administrator does not object to the intended change. In deciding whether to approve a reduced reporting frequency, the Administrator may review information concerning the source's entire previous performance history during the 5-year recordkeeping period prior to the intended change, or the recordkeeping period since the source's compliance date, whichever is shorter. Records subject to review may include performance test results, monitoring data, and evaluations of an owner or operator's conformance with emission limitations and work practice standards. Such information may be used by the Administrator to make a judgment about the source's potential for noncompliance in the future. If the Administrator disapproves the owner or operator's request to reduce reporting frequency, the Administrator will notify the owner or operator in writing within 45 days after receiving notice of the owner or operator's intention. The notification from the Administrator to the owner or operator will specify the grounds on which the disapproval is based. In the absence of a notice of disapproval within 45 days, approval is automatically granted.
(iii) As soon as the monitoring data required by § 63.343(c) show that the source is not in compliance with the relevant emission limit, the frequency of reporting shall revert to quarterly, and the owner shall state this exceedance in the ongoing compliance status report for the next reporting period. After demonstrating ongoing compliance with the relevant emission limit for another full year, the owner or operator may again request approval from the Administrator to reduce the reporting frequency as allowed by paragraph (g)(2) of this section.
(3) Contents of ongoing compliance status reports. The owner or operator of an affected source for which compliance monitoring is required in accordance with § 63.343(c) shall prepare a summary report to document the ongoing compliance status of the source. The report must contain the following information:
(i) The company name and address of the affected source;
(ii) An identification of the operating parameter that is monitored for compliance determination, as required by § 63.343(c);
(iii) The relevant emission limitation for the affected source, and the operating parameter value, or range of values, that correspond to compliance with this emission limitation as specified in the notification of compliance status required by paragraph (e) of this section;
(iv) The beginning and ending dates of the reporting period;
(v) A description of the type of process performed in the affected source;
(vi) The total operating time of the affected source during the reporting period;
(vii) If the affected source is a hard chromium electroplating tank and the owner or operator is limiting the maximum cumulative rectifier capacity in accordance with § 63.342(c)(2), the actual cumulative rectifier capacity expended during the reporting period, on a month-by-month basis;
(viii) A summary of operating parameter values, including the total duration of excess emissions during the reporting period as indicated by those values, the total duration of excess emissions expressed as a percent of the total source operating time during that reporting period, and a breakdown of the total duration of excess emissions during the reporting period into those that are due to process upsets, control equipment malfunctions, other known causes, and unknown causes;
(ix) A certification by a responsible official, as defined in § 63.2, that the work practice standards in § 63.342(f) were followed in accordance with the operation and maintenance plan for the source;
(x) If the operation and maintenance plan required by § 63.342(f)(3) was not followed, an explanation of the reasons for not following the provisions, an assessment of whether any excess emission and/or parameter monitoring exceedances are believed to have occurred, and a copy of the report(s) required by § 63.342(f)(3)(iv) documenting that the operation and maintenance plan was not followed;
(xi) A description of any changes in monitoring, processes, or controls since the last reporting period;
(xii) The number, duration, and a brief description for each type of malfunction which occurred during the reporting period and which caused or may have caused any applicable emission limitation to be exceeded. The report must also include a description of actions taken by an owner or operator during a malfunction of an affected source to minimize emissions in accordance with § 63.342(a)(1), including actions taken to correct a malfunction.
(xiii) The name, title, and signature of the responsible official who is certifying the accuracy of the report; and
(xiv) The date of the report.
(4) When more than one monitoring device is used to comply with the continuous compliance monitoring required by § 63.343(c), the owner or operator shall report the results as required for each monitoring device. However, when one monitoring device is used as a backup for the primary monitoring device, the owner or operator shall only report the results from the monitoring device used to meet the monitoring requirements of this subpart. If both devices are used to meet these requirements, then the owner or operator shall report the results from each monitoring device for the relevant compliance period.
(h) Ongoing compliance status reports for area sources. The requirements of this paragraph do not alleviate affected area sources from complying with the requirements of State or Federal operating permit programs under 40 CFR part 71.
(1) The owner or operator of an affected source that is located at an area source site shall prepare a summary report to document the ongoing compliance status of the affected source. The report shall contain the information identified in paragraph (g)(3) of this section, shall be completed annually and retained on site, and made available to the Administrator upon request. The report shall be completed annually except as provided in paragraph (h)(2) of this section.
(2) Reports of exceedances. (i) If either of the following conditions is met, semiannual reports shall be prepared and submitted to the Administrator:
(A) The total duration of excess emissions (as indicated by the monitoring data collected by the owner or operator of the affected source in accordance with § 63.343(c)) is 1 percent or greater of the total operating time for the reporting period; or
(B) The total duration of malfunctions of the add-on air pollution control device and monitoring equipment is 5 percent or greater of the total operating time.
(ii) Once an owner or operator of an affected source reports an exceedance as defined in paragraph (h)(2)(i) of this section, ongoing compliance status reports shall be submitted semiannually until a request to reduce reporting frequency under paragraph (h)(3) of this section is approved.
(iii) The Administrator may determine on a case-by-case basis that the summary report shall be completed more frequently and submitted, or that the annual report shall be submitted instead of being retained on site, if these measures are necessary to accurately assess the compliance status of the source.
(3) Request to reduce frequency of ongoing compliance status reports. (i) An owner or operator who is required to submit ongoing compliance status reports on a semiannual (or more frequent) basis, or is required to submit its annual report instead of retaining it on site, may reduce the frequency of reporting to annual and/or be allowed to maintain the annual report onsite if all of the following conditions are met:
(A) For 1 full year (e.g., 2 semiannual or 4 quarterly reporting periods), the ongoing compliance status reports demonstrate that the affected source is in compliance with the relevant emission limit;
(B) The owner or operator continues to comply with all applicable recordkeeping and monitoring requirements of subpart A of this part and this subpart; and
(C) The Administrator does not object to a reduced reporting frequency for the affected source, as provided in paragraphs (h)(3) (ii) and (iii) of this section.
(ii) The frequency of submitting ongoing compliance status reports may be reduced only after the owner or operator notifies the Administrator in writing of his or her intention to make such a change, and the Administrator does not object to the intended change. In deciding whether to approve a reduced reporting frequency, the Administrator may review information concerning the source's previous performance history during the 5-year recordkeeping period prior to the intended change, or the recordkeeping period since the source's compliance date, whichever is shorter. Records subject to review may include performance test results, monitoring data, and evaluations of an owner or operator's conformance with emission limitations and work practice standards. Such information may be used by the Administrator to make a judgement about the source's potential for noncompliance in the future. If the Administrator disapproves the owner or operator's request to reduce reporting frequency, the Administrator will notify the owner or operator in writing within 45 days after receiving notice of the owner or operator's intention. The notification from the Administrator to the owner or operator will specify the grounds on which the disapproval is based. In the absence of a notice of disapproval within 45 days, approval is automatically granted.
(iii) As soon as the monitoring data required by § 63.343(c) show that the source is not in compliance with the relevant emission limit, the frequency of reporting shall revert to semiannual, and the owner shall state this exceedance in the ongoing compliance status report for the next reporting period. After demonstrating ongoing compliance with the relevant emission limit for another full year, the owner or operator may again request approval from the Administrator to reduce the reporting frequency as allowed by paragraph (h)(3) of this section.
(i) Reports associated with trivalent chromium baths. The requirements of this paragraph do not alleviate affected sources from complying with the requirements of State or Federal operating permit programs under title V. Owners or operators complying with the provisions of § 63.342(e) are not subject to paragraphs (a) through (h) of this section, but must instead submit the following reports:
(1) Within 180 days after January 25, 1995, submit an initial notification that includes:
(i) The same information as is required by paragraphs (c)(1) (i) through (v) of this section; and
(ii) A statement that a trivalent chromium process that incorporates a wetting agent will be used to comply with § 63.342(e); and
(iii) The list of bath components that comprise the trivalent chromium bath, with the wetting agent clearly identified; and
(2) Within 30 days of the compliance date specified in § 63.343(a), a notification of compliance status that contains an update of the information submitted in accordance with paragraph (i)(1) of this section or a statement that the information is still accurate; and
(3) Within 30 days of a change to the trivalent chromium electroplating process, a report that includes:
(i) A description of the manner in which the process has been changed and the emission limitation, if any, now applicable to the affected source;
(ii) If a different emission limitation applies, the applicable information required by paragraph (c)(1) of this section; and
(iii) The notification and reporting requirements of paragraphs (d), (e), (f), (g), and (h) of this section, which shall be submitted in accordance with the schedules identified in those paragraphs.
§ 63.348   Implementation and enforcement.
(a) This subpart can be implemented and enforced by the U.S. EPA, or a delegated authority such as the applicable State, local, or Tribal agency. If the U.S. EPA Administrator has delegated authority to a State, local, or Tribal agency, then that agency, in addition to the U.S. EPA, has the authority to implement and enforce this subpart. Contact the applicable U.S. EPA Regional Office to find out if implementation and enforcement of this subpart is delegated to a State, local, or Tribal agency.
(b) In delegating implementation and enforcement authority of this subpart to a State, local, or Tribal agency under subpart E of this part, the authorities contained in paragraph (c) of this section are retained by the Administrator of U.S. EPA and cannot be transferred to the State, local, or Tribal agency.
(c) The authorities that cannot be delegated to State, local, or Tribal agencies are as specified in paragraphs (c)(1) through (4) of this section.
(1) Approval of alternatives to the requirements in §§ 63.340, 63.342(a) through (e) and (g), and 63.343(a).
(2) Approval of major alternatives to test methods under § 63.7(e)(2)(ii) and (f), as defined in § 63.90, and as required in this subpart.
(3) Approval of major alternatives to monitoring under § 63.8(f), as defined in § 63.90, and as required in this subpart.
(4) Approval of major alternatives to recordkeeping and reporting under § 63.10(f), as defined in § 63.90, and as required in this subpart.
§ 63.360   Applicability.
(a) You are subject to the requirements of this subpart if you own or operate a sterilization facility that has an affected source specified in paragraph (b) of this section. Table 6 to this subpart shows which parts of the General Provisions in §§ 63.1 through 63.15 apply to you.
(b) The affected sources subject to this subpart are:
(1) Each SCV at any sterilization facility;
(2) Each ARV at any sterilization facility;
(3) Each CEV at any sterilization facility;
(4) The collection of all Group 1 room air emissions at any sterilization facility; and
(5) The collection of all Group 2 room air emissions at any sterilization facility.
(c) An existing affected source is one the construction or reconstruction of which was commenced on or before April 13, 2023.
(d) A new affected source is one the construction or reconstruction of which is commenced after April 13, 2023.
(e) An SCV, ARV, or CEV is reconstructed if you meet the reconstruction criteria as defined in § 63.2, and if you commence reconstruction after April 13, 2023.
(f) This subpart does not apply to beehive fumigators.
(g) This subpart does not apply to research or laboratory facilities as defined in section 112(c)(7) of title III of the Clean Air Act Amendment of 1990.
(h) This subpart does not apply to EtO sterilization operations at stationary sources such as hospitals, doctor's offices, clinics, or other facilities whose primary purpose is to provide medical or dental services to humans or animals.
(i) If you are an owner or operator of an area source subject to this subpart, you are exempt from the obligation to obtain a permit under 40 CFR part 70 or 71, provided you are not required to obtain a permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your status as an area source under this subpart. Notwithstanding the previous sentence, you must continue to comply with the provisions of this subpart applicable to area sources.
(j) You must comply with the provisions of this subpart no later than the dates specified in paragraphs (j)(1) through (17) of this section:
(1) If you own or operate an existing affected source, you must comply with the applicable provisions of this subpart no later than the dates specified in tables 1 through 5 to this subpart, as applicable.
(2) If you own or operate a new affected source, and the initial startup of your affected source is on or before April 5, 2024, you must comply with the provisions of this subpart no later than April 5, 2024.
(3) If you own or operate a new affected source, and the initial startup is after April 5, 2024, you must comply with the provisions of this subpart upon startup of your affected source.
(4) If existing SCV, ARV, or CEV or parts of an existing collection of Group 1 or Group 2 room air emissions are replaced such that the replacement meets the definition of reconstruction in § 63.2 and the reconstruction commenced after April 13, 2023, then the existing affected source becomes a new affected source. The reconstructed source must comply with the requirements for a new affected source upon initial startup of the reconstructed source or by April 5, 2024, whichever is later.
(5) All existing SCVs at facilities that meet or exceed 1 tpy of EtO use within any consecutive 12-month period after April 7, 2025, that increase their EtO use after April 6, 2026, such that the SCV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(6) All existing SCVs at facilities that do not exceed 1 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the SCV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(7) All new SCVs at facilities that increase their EtO use over a year after startup such that the SCV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(8) All existing ARVs at facilities that meet or exceed 10 tpy of EtO use within any consecutive 12-month period after April 7, 2025, that increase their EtO use after April 6, 2026, such that the ARV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(9) All existing ARVs at facilities that do not exceed 10 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use after thereafter, such that the ARV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(10) All new ARVs at facilities that increase their EtO use over a year after startup such that the ARV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(11) All existing CEVs at facilities that do not exceed 60 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the CEV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(12) All new CEVs at facilities that increase their EtO use over a year after startup such that the CEV becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(13) All existing collections of Group 1 room air emissions at facilities that do not exceed 40 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the collection of Group 1 room air emissions becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(14) All new Group 1 room air emissions at facilities that increase their EtO use over a year after startup such that the Group 1 room air emissions become subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(15) All existing collections of Group 2 room air emissions at facilities that meet or exceed 4 tpy of EtO use within any consecutive 12-month period after April 7, 2025, that increase their EtO use after April 6, 2026, such that the collection of Group 2 room air emissions becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(16) All existing collections of Group 2 room air emissions at facilities that do not exceed 4 tpy of EtO use within any consecutive 12-month period after April 6, 2026, that increase their EtO use thereafter, such that the collection of Group 2 room air emissions becomes subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
(17) All new Group 2 room air emissions at facilities that increase their EtO use over a year after startup such that the Group 2 room air emissions become subject to a more stringent emission standard, immediately upon becoming subject to the more stringent emission standard.
§ 63.361   Definitions.
Terms and nomenclature used in this subpart are defined in the Clean Air Act (the Act) as amended in 1990, §§ 63.2 and 63.3, or in this section. For the purposes of this subpart, if the same term is defined in subpart A of this part and in this section, it shall have the meaning given in this section.
Acid-water scrubber means an add-on air pollution control device that uses an aqueous or alkaline scrubbing liquor to absorb and neutralize acid gases.
Aeration means, for the purposes of this rule, exposing sterilized material at elevated temperatures to drive EtO out of the material.
Aeration room means any vessel or room that is used to facilitate off-gassing of EtO at a sterilization facility. If a facility uses only combination sterilization units, for the purposes of this rule, there are no aeration rooms at the facility.
Aeration room vent (ARV) means the point(s) through which the evacuation of EtO-laden air from an aeration room occurs. For combination sterilization units, there is no ARV.
Catalytic oxidizer means a combustion device that uses a solid-phase catalyst to lower the temperature required to promote the oxidization and achieve adequate reduction of volatile organic compounds, as well as volatile hazardous air pollutants.
Chamber exhaust vent (CEV) means the point(s) through which EtO-laden air is removed from the sterilization chamber during chamber unloading following the completion of sterilization and associated air washes. This may also be referred to as a “backvent” (or “back vent”). For combination sterilization units, there is no CEV.
Combination sterilization unit means any enclosed vessel in which both sterilization and aeration of the same product occur within the same vessel, i.e., the vessel is filled with ethylene oxide gas or an ethylene oxide/inert gas mixture for the purpose of sterilizing and is followed by aeration of ethylene oxide.
Combined emission stream means when the emissions from more than one emission source are routed together using common ductwork prior to the control system.
Continuous monitoring system (CMS) means, for the purposes of this rule, the equipment necessary to continuously samples the regulated parameter specified in § 63.364 or § 63.365 of this subpart without interruption, evaluates the detector response at least once every 15 seconds, and computes and records the average value at least every 60 seconds, except during allowable periods of calibration and except as defined otherwise by the continuous emission monitoring system (CEMS) performance specifications (PS) in appendix B to part 60 of this chapter.
Control System Residence Time means the time elapsed from entrance of flow into the control system until gaseous materials exit the control system. For control systems with multiple exhaust streams whereby the residence time may vary for the streams, the residence time for purposes of complying with this subpart means the longest residence time for any exhaust stream in use. If a peak shaver is used, it is part of the control system, and its residence time must be considered.
Deviation means any instance in which an owner or operator of an affected source, subject to this subpart:
(1) Fails to meet any requirement or obligation established by this subpart including, but not limited to, any emission limitation, parameter value, or best management practice; or
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart or that is included in the operating permit for any facility required to obtain such a permit.
EtO dispensing means charging a sterilization chamber or chambers with EtO from non-cartridge storage media ( e.g., drums, cylinders) via the use of piping, lines, and other equipment. This includes injection rooms and post-injection handling of containers.
Gas/solid reactor means an add-on air pollution control device that uses a dry, solid-phase system to chemically convert EtO so that it becomes bound to the solid packing. This may also be referred to as a “dry bed reactor” or a “dry bed scrubber.”
Group 1 room air emissions mean emissions from indoor EtO storage, EtO dispensing, vacuum pump operations, and pre-aeration handling of sterilized material.
Group 2 room air emissions mean emissions from post-aeration handling of sterilized material.
Indoor EtO storage means the storage of EtO within non-cartridge media ( e.g., drums, cylinders) inside a sterilization building.
Initial startup means the moment when an affected source subject to an emissions standard in § 63.362 first begins operation.
Injection room means any room where EtO is injected into containers ( e.g., bags, pouches) that are filled with product to be sterilized.
Maximum ethylene glycol concentration means the concentration of ethylene glycol in the scrubber liquor of an acid-water scrubber control device established during a performance test when the scrubber achieves the appropriate control of EtO emissions.
Maximum gas/solid reactor pressure drop means the pressure drop of the gas/solid reactor established during a performance test when the gas/solid reactor achieves the appropriate control of EtO emissions.
Maximum liquor tank level means the level of scrubber liquor in the acid-water scrubber liquor recirculation tank established during a performance test when the scrubber achieves the appropriate control of EtO emissions.
Maximum scrubber liquor pH means the pH of the acid-water scrubber liquor established during a performance test when the scrubber achieves the appropriate control of EtO emissions.
Minimum stack volumetric flow rate means the stack volumetric flow rate corrected established during a compliance demonstration when permanent total enclosure (PTE) requirements are met.
Minimum temperature at the inlet to the catalyst bed means the temperature at the inlet to the catalyst bed established during a performance test when the catalytic oxidizer achieves the appropriate control of EtO emissions.
Minimum temperature difference across the catalyst bed means the temperature difference across the catalyst bed established during a performance test when the catalytic oxidizer achieves the appropriate control of EtO emissions.
Minimum temperature in or immediately downstream of the firebox means the temperature in or immediately downstream of the firebox established during a performance test when the thermal oxidizer achieves the appropriate control of EtO emissions.
Natural draft opening (NDO) means any permanent opening in the enclosure that remains open during operation of the facility and is not connected to a duct in which a fan is installed.
Operating day means any day that a facility is engaged in a sterilization operation.
Peak shaver means a device that is used to reduce high EtO concentrations within an exhaust stream such that the downstream control device is not overwhelmed.
Permanent total enclosure (PTE) means a permanently installed enclosure that meets the criteria of Method 204 of appendix M, 40 CFR part 51 for a PTE. A PTE completely surrounds a source of emissions such that all EtO emissions are captured, contained, and directed to a control system or to an outlet(s).
Post-aeration handling of sterilized material means the storage and transportation of material that has been removed from aeration but has not been placed in a vehicle for the sole purpose of distribution to another facility. Post-aeration handling of sterilized material ends when that vehicle is closed for the final time before leaving the facility. This definition does not include handling of material that has been both previously sterilized and not removed from aeration following re-sterilization.
Post-injection handling of containers means the storage and transportation of containers ( e.g., bags, pouches) that have been injected with EtO but have not been placed in a sterilization chamber.
Pre-aeration handling of sterilized material means the storage and transportation of material that has been removed from a sterilization chamber but has not been placed in an aeration room. If only combination sterilization units are used, and if material is not moved out of the vessel between sterilization and aeration, then emissions from this source do not exist. This does not include post-injection handling of containers.
Rolling sum means the weighted sum of all data, meeting QA/QC requirements or otherwise normalized, collected during the applicable rolling time period. The period of a rolling sum stipulates the frequency of data collection, summing, and reporting. As an example, to demonstrate compliance with a rolling 30-operating day sum emission reduction standard determined from hourly data, you must (1) determine the total mass of ethylene oxide prior to control and following control for each operating day; (2) then sum the current daily total mass prior to control with the previous 29 operating day total mass values and repeat the same process for the current daily total mass following control; and (3) then divide the 30-operating day total mass emissions following control by the 30-operating day total mass prior to control and subtract the resulting value from one to obtain the 30-operating day emission reduction achieved.
Single-item sterilization means a process in which one or more items are placed in a pouch, EtO is injected into the pouch, and the sealed pouch is placed in a vessel to allow sterilization to occur.
Sterilization chamber means any enclosed vessel or room that is filled with EtO gas, or an EtO/inert gas mixture, for the purpose of sterilizing and/or fumigating at a sterilization facility. This does not include injection rooms.
Sterilization chamber vent (SCV) means the point (prior to the vacuum pump) through which the evacuation of EtO from the sterilization chamber occurs following sterilization or fumigation, including any subsequent air washes.
Sterilization facility means any stationary source where EtO is used in the sterilization or fumigation of materials, including but not limited to facilities that engage in single-item sterilization.
Sterilization operation means any time when EtO is removed from the sterilization chamber through the SCV or the chamber exhaust vent, when EtO is removed from the aeration room through the aeration room vent, when EtO is stored within the building, when EtO is dispensed from a container to a chamber, when material is moved from sterilization to aeration, or when materials are handled post-aeration.
Thermal oxidizer means all combustion devices except flares.
Vacuum pump operation means the operation of vacuum pumps, excluding dry seal vacuum pumps, for the purpose of removing EtO from a sterilization chamber.
§ 63.362   Standards.
(a) Compliance date. If you own or operate an affected source, you must comply with the applicable requirement by the compliance date specified in § 63.360(j). The standards of this section are summarized in tables 1 through 5 to this subpart.
(b) Applicability of standards. The standards in paragraphs (c) through (k) of this section apply at all times. If using EtO CEMS to determine compliance with an applicable standard, this compliance demonstration is based on the previous 30-operating days of data. If using EtO CEMS to determine compliance with an applicable emission reduction standard in paragraphs (c) through (g) and (i) of this section for each operating day, you must determine the total inlet mass to and outlet mass from the control system using the procedures laid out in § 63.364(f) and appendix A to this subpart, and you must maintain the emission limit based on the inlet mass and the applicable emission reduction standard. If using EtO CEMS to determine compliance with an applicable emission reduction standard in paragraph (j) of this section, you must continuously comply with the requirements of that paragraph.
(c) SCV. You must comply with each applicable standard in table 1 to this subpart, and you must meet each applicable requirement specified in § 63.363. If a SCV is combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.
(d) ARV. You must comply with each applicable standard in table 2 to this subpart, and you must meet each applicable requirement specified in § 63.363. If an ARV is combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.
(e) CEV. You must comply with each applicable standard in table 3 to this subpart, and you must meet each applicable requirement specified in § 63.363. If a CEV is combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.
(f) Group 1 room air emissions. You must comply with the applicable standard in table 4 to this subpart, and you must meet each applicable requirement specified in § 63.363. If Group 1 room air emissions are combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.
(g) Group 2 room air emissions. You must comply with the applicable standard in table 5 to this subpart, and you must meet each applicable requirement specified in § 63.363. If Group 2 room air emissions are combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section. If you are required to limit the sterilization chamber concentration of EtO to 1 ppmv prior to opening the sterilization chamber door, you must meet the monitoring requirements specified in § 63.364(h).
(h) Capture systems. Room air emissions for which numerical limits are prescribed must be captured and routed under negative pressure to a control system. You may assume the capture system efficiency is 100 percent if both conditions in paragraphs (h)(1) and (2) of this section are met:
(1) The capture system meets the criteria in Method 204 of appendix M to 40 CFR part 51 for a PTE and directs all the exhaust gases from the enclosure to an add-on control system.
(2) All sterilization operations creating exhaust gases for which the compliance demonstration is applicable are contained within the capture system.
(i) Requirements for combined emission streams. When streams from two or more emission sources are combined, you must demonstrate compliance by either the approach specified in paragraph (i)(1) of this section or the approach specified in paragraph (i)(2) of this section in lieu of the applicable standards in paragraphs (c) through (g) of this section for the affected source. The combined emission stream limit is based on as 30-operating day rolling sum. In order to elect to comply with a combined emission streams limit, you must use a CEMS on each exhaust stack at the facility to determine compliance.
(1) Monitoring after emission streams are combined. You must follow requirements of paragraphs (i)(1)(i) through (iii) of this section to determine the applicable combined emission streams limitation and demonstrate compliance. Under this approach, you must first determine the 30-operating day rolling sum of mass inlet to the control system. Then, the emission limitation is determined by applying the most stringent emission reduction standard to the 30-operating day rolling sum of the inlet mass. You must maintain actual emissions at or below that rate. For example, suppose a facility controls all of its ARVs and CEVs with one control system and that the emission reduction standards that apply to the ARVs and CEVs are 99.9% and 99%, respectively. Further suppose that the mass of uncontrolled EtO emissions from the combined stream is 5 lb during the 30-operating day period. Under this approach, the facility would need to apply an emission reduction of 99.9% to the combined stream, resulting in an emission limit of 0.005 lb for the 30-operating day period.
(i) The combined emission streams limit for each 30-operating day period is determined daily by using equation 1 to this paragraph.
(ii) The 30-operating day rolling sum of emissions for the combined emission stream ( i.e., monitoring data at the outlet of the control system) is calculated daily using equation A-3 and determined in accordance with appendix A to this subpart. For purposes of this section, this value is designated as E Combined . If the combined emission stream is split between two or more control systems, further sum the 30-operating day rolling sum of emissions from each control system to obtain E Combined .
(iii) Compliance with the combined emission streams limitation shall be determined by demonstrating that E Combined , as calculated in accordance with paragraph (i)(1)(ii) of this section, for each 30-operating day period is at or below CES Combined , as calculated in paragraph (i)(1)(i) of this section.
(2) Monitoring before emission streams are combined. You must follow requirements of paragraphs (i)(2)(i) through (iii) of this section to determine the applicable combined emission streams limitation and demonstrate compliance. Under this approach, you must first determine 30-operating day rolling sum of inlet mass to the control system for each component stream. Then, the emission limitation is determined by applying the applicable emission reduction standards to the 30-operating day rolling sum of each component stream and summing across the components. You must maintain actual emissions at or below that rate. For example, suppose a facility controls all of its ARVs and CEVs with one control system and that the emission reduction standards that apply to the ARVs and CEVs are 99.9% and 99%, respectively. Further suppose that during a 30-operating day period the mass of uncontrolled EtO emissions from the ARVs is 4 lb and the mass of uncontrolled EtO emissions from the CEVs is 1 lb. Under this approach, the facility would need to apply an emission reduction of 99.9% to the ARV stream and an emission reduction of 99% to the CEV stream, resulting in an emission limit of 0.014 lb for the 30-operating day period.
(i) The combined emission streams limit for each 30-operating day period is determined daily by using equation 2 to this paragraph.
(ii) The 30-operating day rolling sum emissions for the combined emission stream ( i.e., monitoring data at the outlet of the control system) is calculated daily using equation A-3 and determined in accordance with appendix A to this subpart. For purposes of this section, this value is designated as E Combined . If the combined emission stream is split between two or more control systems, then further sum the 30-operating day rolling sum emissions from each control system to obtain E Combined .
(iii) Compliance with the combined emission streams limitation shall be determined by demonstrating that E Combined , as calculated in accordance with paragraph (i)(2)(ii) of this section, for each 30-operating day period is at or below CES Streams , as calculated paragraph (i)(2)(i) of this section.
(3) If room air emissions are both subject to an emission standard and split between two or more control systems, then these control systems must be treated as part of the same control system.
(j) Site-wide emission limitation. You may choose to comply with a site-wide emission limitation (SWEL) specified in this paragraph (j) in lieu of the applicable standards in paragraphs (c) through (g) of this section for the facility. The SWEL, which is calculated daily, is based on the previous 30 operating days of data. In order to elect to comply with a SWEL, you must utilize an EtO CEMS on each exhaust stack at the facility to determine compliance. The owner or operator may demonstrate compliance via one of the two SWEL approaches in lieu of the applicable standard(s) in paragraphs (c) through (g) of this section for the facility. If electing to comply with a SWEL, you must comply with paragraph (j)(3) of this section.
(1) SWEL based upon facility EtO use. If you elect to comply with a SWEL based upon facility EtO use, you must follow requirements of paragraphs (j)(1)(i) through (iii) of this section to determine the applicable SWEL and demonstrate compliance. Under this approach, you first determine the 30-operating day rolling sum of EtO use. The SWEL is determined by multiplying by 0.99 and then applying the required SCV percent emission reduction standard in table 1 to this subpart to the 30-operating day rolling sum of EtO usage. Then, for each CEMS at the outlet of the control systems at the facility, determine the 30-operating day rolling sum of emissions. Finally, determine the facility actual emissions by summing the 30-operating day rolling sums for each CEMS at the facility. You must maintain actual emissions at or below the SWEL.
(i) The SWEL for each 30-operating day period is determined daily by using equation 3 to this paragraph.
(ii) The 30-operating day rolling sum of emissions are determined daily using equation 4 to this paragraph.
(iii) Compliance with the SWEL based upon facility EtO usage shall be determined by demonstrating that E Fac , as calculated in accordance with paragraph (j)(1)(ii) of this section, for each 30-operating day period is at or below the SWEL, as calculated paragraph (j)(1)(i) of this section.
(2) SWEL based upon emissions streams. If you elect to comply with a SWEL based upon emissions streams, you must follow requirements of paragraphs (j)(2)(i) through (iii) of this section to determine the applicable SWEL and demonstrate compliance. Under this approach, for each non-SCV affected source, you must determine the mass of EtO sent to controls and apply the applicable emission reduction standard. For each SCV affected source, you must determine the mass of EtO sent to controls as specified in § 63.364(f)(1)(i)(C)( 1 ) and apply the applicable emission reduction standard. The SWEL is determined by summing across the result of this calculation for each affected source (both non-SCV and SCV). Then, for each CEMS at the outlet of the control system(s) at the facility, determine the 30-operating day rolling sum of emissions. Finally, determine the facility actual emissions by summing the 30-operating day rolling sums for each CEMS at the facility. You must maintain actual emissions at or below the SWEL.
(i) The SWEL for each 30-operating day period is determined daily by using equation 5 to this paragraph.
(ii) The 30-operating day rolling sum of emissions are determined daily using equation 4 to this section.
(iii) Compliance with the SWEL based upon emission streams shall be determined by demonstrating that E Fac , as calculated in accordance with paragraph (j)(2)(ii) of this section, for each 30-operating day period is at or below SWEL Streams , as calculated in paragraph (j)(2)(i) of this section.
(3) Boundary. The boundary for this approach includes all affected sources at the facility.
(k) General duty. At all times, you must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.
§ 63.363   Compliance and performance provisions.
(a) Continuous compliance. You must demonstrate continuous compliance with the applicable emission standard(s) using an EtO CEMS, including a shared EtO CEMS, installed and operated in accordance with the requirements of Performance Specification 19 in appendix B and Procedure 7 in appendix F to part 60 of this chapter. Alternatively, if you own or operate a facility where EtO use is less than 100 pounds/yr, you may demonstrate continuous compliance by conducting annual performance tests using the performance testing requirements in § 63.7, according to the applicability in table 6 to this subpart, the procedures listed in this section, and the test methods listed in § 63.365. If you elect to demonstrate compliance through periodic performance testing, you must also demonstrate continuous compliance with each operating limit required under this section according to the methods specified in § 63.364. If you own or operate an area source facility where EtO use is less than 100 pounds/yr where an existing collection of Group 2 room air emission is operated in accordance with the PTE requirements of EPA Method 204 of appendix M to part 51 of this chapter, you may instead conduct these performance tests once every three years.
(b) Initial compliance for Facilities that use EtO CEMS. To demonstrate initial compliance with an emission standard using a CEMS that measures HAP concentrations directly ( i.e., an EtO CEMS), the initial performance test must consist of the first 30 operating days after the certification of the CEMS according to Performance Specification 19 in Appendix B to part 40 of this chapter. The initial compliance demonstration period must be completed on or before the date that compliance must be demonstrated ( i.e., 180 days after the applicable compliance date). You must follow the procedures in appendix A to this subpart.
(1) The CEMS performance test must demonstrate compliance with the applicable EtO standards in tables 1 through 5 to this subpart. Alternatively, the CEMS performance test may demonstrate compliance with § 63.362(i) or (j).
(i) You may time-share your CEMS among different measurement points provided that:
(A) The measurement points are approximately equidistant from the CEMS;
(B) The sampling time at each measurement point is at least 3 times as long as the CEMS response time;
(C) The CEMS completes at least one complete cycle of operation for each shared measurement point within a 15-minute period; and
(D) The CEMS meets the other requirements of PS 19.
(2) You must collect hourly data from auxiliary monitoring systems during the performance test period, to convert the pollutant concentrations to pounds per hour.
(c) Initial compliance demonstration where facility EtO use is less than 100 pounds per year. If you own or operate an affected source that is both subject to an emission standard in § 63.362 and located within a facility where EtO use is less than 100 pounds per year, you may comply with paragraphs (c)(1) and (2) of this section:
(1) Conduct an initial compliance demonstration using the procedures listed in § 63.7 of this part according to the applicability in table 6 to this subpart, the procedures listed in this section, and the test methods listed in § 63.365;
(2) Complete the initial compliance demonstration within 180 days after the compliance date for the affected source as determined in § 63.360(j).
(d) Operating limits for facility where EtO use is less than 100 lb/yr. If annual EtO use at the facility is less than 100 lb, the procedures in paragraphs (d)(1) through (5) of this section may be used to determine compliance with the standard(s) under § 63.362(c) through (g) and to establish operating limits for each of the control devices, as applicable:
(1) You must determine the percent emission reduction of the control system used to comply with § 63.362(c) through (g) using the test methods and procedures in § 63.365(d)(1).
(2) If an acid-water scrubber(s) is used to comply with a standard, then you must establish as an operating limit:
(i) The maximum ethylene glycol concentration using the procedures described in § 63.365(e)(1)(i);
(ii) The maximum liquor tank level using the procedures described in § 63.365(e)(1)(ii); or
(iii) The maximum scrubber liquor pH using the procedures described in § 63.365(e)(1)(iii).
(3) If a thermal oxidizer(s) is used to comply with a standard, you must establish as an operating limit the minimum temperature in or immediately downstream of the firebox using the procedures described in § 63.365(e)(2).
(4) If a catalytic oxidizer(s) is used to comply with the standard, you must establish as operating limits both:
(i) The minimum temperature at the inlet to the catalyst bed using the procedures described in § 63.365(e)(3); and
(ii) The minimum temperature difference across the catalyst bed using the procedures described in § 63.365(e)(3).
(5) If a gas/solid reactor(s) is used to comply with the standard, you must establish as an operating limit the pressure drop across the media beds and conduct weekly sampling and analysis of the media. Determine the maximum gas/solid reactor pressure drop using the procedures described in § 63.365(e)(4).
(e) Other control technology for facility where EtO use is less than 100 lb/yr. If you are conducting a performance test using a control technology other than an acid-water scrubber, catalytic oxidizer, thermal oxidizer, or gas/solid reactor, you must provide to the Administrator information describing the design and operation of the air pollution control system, including recommendations for the parameters to be monitored that will demonstrate continuous compliance. Based on this information, the Administrator will determine the parameter(s) to be measured during the performance test. During the performance test required in paragraph (a) of this section, using the methods approved in § 63.365(e)(5), you must determine the site-specific operating limit(s) for the operating parameters approved by the Administrator. You must submit the information at least sixty days before the performance test is scheduled to begin. The information on the control technology must include the five items listed in paragraphs (1) through (5) of this section:
(1) Identification of the specific parameters you propose to use as additional operating limits;
(2) A discussion of the relationship between these parameters and emissions of regulated pollutants, identifying how emissions of regulated pollutants change with changes in these parameters and how limits on these parameters will serve to limit emissions of regulated pollutants;
(3) A discussion of how you will establish the upper and/or lower values which will establish the operating limits for these parameters;
(4) A discussion identifying the methods you will use to measure and the instruments you will use to monitor these parameters, as well as the relative accuracy and precision of these methods and instruments; and
(5) A discussion identifying the frequency and methods for recalibrating the instruments you will use for monitoring these parameters.
(f) Other emission streams. If the emission stream does not consist only of an SCV(s), the procedures in paragraphs (f)(1) through (3) of this section shall be used to determine initial compliance with the emission limits under § 63.362(d) through (g), as applicable:
(1) You must comply with paragraph (c) of this section, as applicable.
(2) If you are complying with a percent emission reduction standard as specified in tables 1 through 5 to this subpart, you must determine compliance with § 63.362(c) through (g), as applicable, using the test methods and procedures in § 63.365(d)(1).
(3) If you are required to operate any portion of the facility under PTE, you must initially demonstrate that the PTE meets the requirements of Method 204 of 40 CFR part 51, appendix M, and that all exhaust gases from the enclosure are delivered to a control system or stack(s). You must also meet the requirements in § 63.363(f)(3)(i) and either § 63.363(f)(3)(ii) or (iii):
(i) Maintain direction of the airflow into the enclosure at all times, verifying daily using the procedures described in § 63.364(f)(5) and meet either of the requirements.
(ii) Establish as an operating limit the minimum volumetric flow rate through the affected stack(s) using the procedures described in § 63.365(f)(1); or
(iii) Install, operate, calibrate, and maintain a continuous pressure differential monitoring system using the procedures described in § 63.364(f)(4).
§ 63.364   Monitoring requirements.
(a) General requirements. (1) If you own or operate an affected source subject to an emission standard in § 63.362, you must comply with the monitoring requirements in § 63.8, according to the applicability in table 6 to this subpart, and in this section.
(2) If you own or operate an affected source at a facility where EtO use is less than 100 lb/yr that is subject to an emission standard in § 63.362, you may monitor the parameters specified in paragraphs (b), (c), (d), (e), (g), and (i) of this section. All monitoring equipment shall be installed such that representative measurements of emissions or process parameters from the source are obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the monitoring equipment shall include completion of the manufacturer's written specifications or recommendations for installation, operation, and calibration of the system.
(3) If you own or operate an affected source that is subject to an emission standard in § 63.362 and that is required to monitor using EtO CEMS, you must comply with paragraphs (f), (g), and (i) of this section.
(4) If you comply with the management practice for Group 2 room air emissions at area sources, you must comply with paragraph (h) of this section.
(5) You must keep the written procedures required by § 63.8(d)(2) on record for the life of the affected source or until the affected source is no longer subject to the provisions of this part, to be made available for inspection, upon request, by the Administrator. If the performance evaluation plan is revised, you must keep previous ( i.e., superseded) versions of the performance evaluation plan on record to be made available for inspection, upon request, by the Administrator, for a period of 5 years after each revision to the plan. The program of corrective action should be included in the plan required under § 63.8(d)(2).
(b) Acid-water scrubbers. If you are demonstrating continuous compliance through periodic performance testing on an acid-water scrubber(s), you must:
(1) Ethylene glycol concentration. Sample the scrubber liquor from the acid-water scrubber(s) and analyze and record at least once per week the ethylene glycol concentration of the scrubber liquor using the test methods and procedures in § 63.365(e)(1). Monitoring is required during a week only if the scrubber unit has been operated. You must maintain the weekly ethylene glycol concentration below the operating limit established during the most recent performance test;
(2) Scrubber liquor tank level. Measure and record at least once per day the level of the scrubber liquor in the recirculation tank(s). You must install, maintain, and use a liquid level indicator to measure the scrubber liquor tank level ( i.e., a marker on the tank wall, a dipstick, a magnetic indicator, etc.). Monitoring is required during a day only if the scrubber unit has been operated. You must maintain the daily scrubber liquor height in each recirculation tank below the applicable operating limit established during the most recent performance test; or
(3) pH. Monitor and record at least every 15 minutes the scrubber liquor pH. Monitoring is required when the scrubber is operating. A data acquisition system for the pH monitor shall compute and record each 3-hour average scrubber liquor pH value, rolled hourly. This must be done by first averaging the scrubber liquor pH readings obtained over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even if the scrubber unit is not operating for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average scrubber liquor pH. You must maintain the 3-hour rolling average scrubber liquor pH below the applicable operating limit established during the most recent performance test. You must ensure the pH monitoring system meets the following requirements:
(i) The pH sensor must be installed in a position that provides a representative measurement of scrubber liquor pH;
(ii) The sample must be properly mixed and representative of the fluid to be measured; and
(iii) A performance evaluation (including a two-point calibration with one of the two buffer solutions having a pH within 1 of the pH of the operating limit) of the pH monitoring system must be conducted in accordance with your monitoring plan at the time of each performance test but no less frequently than quarterly.
(c) Oxidizers. If you are demonstrating continuous compliance through periodic performance testing on a catalytic oxidizer or thermal oxidizer, the requirements in paragraphs (c)(1) and (2) of this section apply:
(1) For thermal oxidizers, you must monitor and record at least every 15 minutes the temperature in or immediately downstream of the firebox using the temperature monitor described in paragraph (c)(4) of this section. Monitoring is required when the thermal oxidizer is operating. A data acquisition system for the temperature monitor shall compute and record each 3-hour average temperature value, rolled hourly. This must be done by first averaging the temperature readings over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even if the thermal oxidizer is not operating for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average temperature in or immediately downstream of the firebox. You must maintain the 3-hour rolling average temperature above the operating limit established during the most recent performance test.
(2) For catalytic oxidizers, you must monitor and record at least every 15 minutes the temperature at the inlet to the catalyst bed using the temperature monitor described in paragraph (c)(4) of this section. Monitoring is required when the catalytic oxidizer is operating. A data acquisition system for the temperature monitor shall compute and record each 3-hour average temperature, rolled hourly. This must be done by first averaging the temperature readings over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even if the catalytic oxidizer is not operating for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average temperature at the inlet to the catalyst bed. You must maintain the 3-hour rolling average temperature above the operating limit established during the most recent performance test.
(3) For catalytic oxidizers, you must monitor and record at least every 15 minutes the temperature increase across the catalyst bed, immediately downstream of the catalytic bed, using the temperature monitor described in paragraph (c)(4) of this section. Monitoring is required when the catalytic oxidizer is operating. A data acquisition system for the temperature monitor shall compute and record each 3-hour average temperature increase, rolled hourly. This must be done by first computing the difference in outlet temperature minus inlet temperature (monitored under paragraph (c)(2)), and second averaging the temperature difference values over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even if the catalytic oxidizer is not operating for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average temperature increase across the catalyst bed. You must maintain the 3-hour average temperature increase above the operating limit established during the most recent performance test.
(4) You must install, calibrate, operate, and maintain a temperature monitor with a minimum accuracy of ±1 percent over the normal range of the temperature measured, expressed in degrees Celsius, or 2.8 degrees Celsius, whichever is greater. You must verify the accuracy of the temperature monitor twice each calendar year at least five months apart with a reference temperature monitor (traceable to National Institute of Standards and Technology (NIST) standards or an independent temperature measurement device dedicated for this purpose). During accuracy checking, the probe of the reference device shall be at the same location as that of the temperature monitor being tested. As an alternative, the accuracy of the temperature monitor may be verified in a calibrated oven (traceable to NIST standards).
(5) For catalytic oxidizers, if the monitor indicates that the temperature is below the operating limit, within 7 calendar days you must:
(i) Correct the temperature or temperature increase so that it falls within the established operating range; or
(ii) Replace the catalyst bed. Following replacement of the catalyst bed, you must conduct a new performance test within 180 days and re-establish the operating limits.
(d) Gas-solid reactors. If you are demonstrating continuous compliance through periodic performance testing on a gas/solid reactor(s), you must:
(1) Media analysis. Sample the media from the gas/solid reactor(s) and have the manufacturer analyze at least once per week. Monitoring is required during a week only if the gas/solid reactor unit has been operated; and
(2) Pressure drop. Monitor and record at least every 15 minutes the pressure drop. Monitoring is required when the gas/solid reactor is operating. A data acquisition system for the pressure drop monitor shall compute and record each 3-hour average gas/solid reactor pressure drop value, rolled hourly. This must be done by first averaging the gas/solid reactor pressure drop readings obtained over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even if the gas/solid reactor unit is not operating for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average gas/solid reactor pressure drop. You must maintain the 3-hour rolling average gas/solid reactor pressure drop below the applicable operating limit established during the most recent performance test.
(e) Performance testing, other control technology. If you are complying with § 63.363(d) or (e) using periodic performance testing and the use of a control device other than acid-water scrubbers, catalytic or thermal oxidizers, or gas/solid reactors, you must monitor the parameters as approved by the Administrator using the methods and procedures in § 63.365(e).
(f) EtO CEMS configurations. If you are using EtO CEMS to demonstrate compliance with an emission standard, you must install and operate an EtO CEMS on each outlet for the control system in accordance with the requirements of Appendix A to subpart O of this part. You must also conduct monitoring for each inlet to the control system that is used to demonstrate compliance with the emission reduction standard in accordance with the requirements of appendix A to this subpart, with the exception for SCV emission streams to the control system.
(1) EtO CEMS inlet configuration. The following caveats apply:
(i) SCVs. If you do not own or operate a single-item sterilizer, to demonstrate compliance with the percent emission reduction standards for emissions streams that are comprised only of SCVs, you may use the following procedures as an alternative to monitoring the inlet emission stream to determine the mass emissions of EtO being emitted via sterilization chamber(s) vents prior to the controls.
(A) Determine the mass (M SCV,n ) of EtO used for each charge and at each sterilization chamber used during the previous 30 days using the procedures in either paragraph (f)(1)(i)(A)( 1 ) or ( 2 ) of this section.
( 1 ) Weigh the EtO gas cylinder(s) used to charge the sterilizer(s) before and after charging. Record these weights to the nearest 45 g (0.1 lb) and calculate the theoretical mass (M c ) vented to the controls using equation 1 to this paragraph.
( 2 ) Install a calibrated rate meter at the sterilizer inlet(s) and continuously measure the flow rate (Q m ) and duration of each sterilizer charge. Calculate the theoretical mass (M SCV,n ) vented to the controls using equation 2 to this paragraph.
(B) Determine the adjustment factor ( f ) using equation 8 to this paragraph. Determine the mass of EtO sent to controls from all non-SCV affected sources, I, using equation 4 to this paragraph. For facilities where EtO use is less than 4 tpy, if not all Group 2 room air emissions are routed to a control device, do not include Group 2 room air emissions in I, and subtract 0.002 from this factor.
(C)( 1 ) Determine the mass rate of EtO sent to controls during the previous 30 days using equation 5 to this paragraph.
( 2 ) If both this approach is chosen and the SCV is (or SCVs are) combined with another emission stream, then the owner or operator cannot monitor the point after the combination occurs.
(ii) Room air emissions. If room air emissions are both subject to an emission standard and split between two or more control systems, then monitoring must be conducted for room air emissions before they are combined with other streams.
(2) EtO CEMS on exhaust configurations. Exhaust gases from the emission sources under this subpart exhaust to the atmosphere through a variety of different configurations, including but not limited to individual stacks, a common stack configuration, or a main stack plus a bypass stack. For the CEMS used to provide data under this subpart, the continuous monitoring system installation requirements for these exhaust configurations are as follows:
(i) Single unit-single stack configurations. For an emission source that exhausts to the atmosphere through a single, dedicated stack, you shall either install the required CEMS in the stack or at a location in the ductwork downstream of all emissions control devices, where the pollutant and diluents concentrations are representative of the emissions that exit to the atmosphere.
(ii) Unit utilizing common stack with other emission source(s). When an emission source utilizes a common stack with one or more other emission sources, but no emission sources not subject to this rule, you shall either:
(A) Install the required CEMS in the duct from each emission source, leading to the common stack; or
(B) Install the required CEMS in the common stack.
(iii) Unit(s) utilizing common stack with non-commercial sterilization emission source(s). (A) When one or more emission sources shares a common stack with one or more emission sources not subject to this rule, you shall either:
( 1 ) Install the required CEMS in the ducts from each emission source that is subject to this rule, leading to the common stack; or
( 2 ) Install the required CEMS described in this section in the common stack and attribute all of the emissions measured at the common stack to the emission source(s).
(B) If you choose the common stack monitoring option:
( 1 ) For each hour in which valid data are obtained for all parameters, you must calculate the pollutant emission rate; and
( 2 ) You must assign the calculated pollutant emission rate to each of the units subject to the rule that share the common stack.
(iv) Unit with multiple parallel control devices with multiple stacks. If the exhaust gases from an emission source, which is configured such that emissions are controlled with multiple parallel control devices or multiple series of control devices are discharged to the atmosphere through more than one stack, you shall install the required CEMS described in each of the multiple stacks. You shall calculate hourly, flow-weighted, average pollutant emission rates for the unit as follows:
(A) Calculate the pollutant emission rate at each stack or duct for each hour in which valid data are obtained for all parameters;
(B) Multiply each calculated hourly pollutant emission rate at each stack or duct by the corresponding hourly gas flow rate at that stack or duct;
(C) Sum the products determined under paragraph (f)(2)(iv)(B) of this section; and
(D) Divide the result obtained in paragraph (f)(2)(I(C) of this section by the total hourly gas flow rate for the unit, summed across all of the stacks or ducts.
(g) PTE monitoring. If you are required to operate all or a portion of your sterilization facility under PTE conditions, you must:
(1) Initial compliance. Demonstrate initial procedures in § 63.365(g)(1) and continued compliance with the provisions in this section. You must follow the requirements of either paragraphs (g)(2) and (3) of this section or paragraph (g)(4) of this section.
(2) Continuous compliance. If you choose to demonstrate continuous compliance through volumetric flow rate monitoring, you must monitor and record at least every 15 minutes the volumetric flow rate from each outlet where air from the PTE is sent using a flow rate monitoring system described in paragraph (g)(3) of this section. Monitoring is required when the portion of the facility covered by PTE is operated. A data acquisition system for the flow rate monitoring system shall compute and record each 3-hour average flow rate value, rolled hourly. This must be done by first averaging the flow rate readings over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even the portion of the facility covered by PTE is not operated for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average flow rate. You must maintain the 3-hour rolling average flow rate above the applicable operating limits established during the most recent compliance demonstration.
(3) Continuous flow rate monitoring system for PTE. You must install, operate, calibrate, and maintain instruments, according to the requirements in paragraphs (g)(3)(i) through (ix) of this section, for continuously measuring and recording the stack gas flow rate to allow determination of compliance with the minimum volumetric flow rate through the affected stack operating limit(s).
(i) You must install each sensor of the flow rate monitoring system in a location that provides representative measurement of the exhaust gas flow rate. The flow rate sensor is that portion of the system that senses the volumetric flow rate and generates an output proportional to that flow rate.
(ii) The flow rate monitoring system must be designed to measure the exhaust flow rate over a range that extends from a value of at least 20 percent less than the lowest expected exhaust flow rate to a value of at least 20 percent greater than the highest expected exhaust flow rate.
(iii) The flow rate monitoring system must be equipped with a data acquisition and recording system that is capable of recording values over the entire range specified in paragraph (g)(3)(ii) of this section.
(iv) The signal conditioner, wiring, power supply, and data acquisition and recording system for the flow rate monitoring system must be compatible with the output signal of the flow rate sensors used in the monitoring system.
(v) The flow rate monitoring system must be designed to complete a minimum of one cycle of operation for each successive 15-minute period.
(vi) The flow rate sensor must have provisions to determine the daily zero and upscale calibration drift (CD) ( see sections 3.1 and 8.3 of Performance Specification 2 in appendix B to Part 60 of this chapter for a discussion of CD).
(A) Conduct the CD tests at two reference signal levels, zero ( e.g., 0 to 20 percent of span) and upscale ( e.g., 50 to 70 percent of span).
(B) The absolute value of the difference between the flow monitor response and the reference signal must be equal to or less than 3 percent of the flow monitor span.
(vii) You must perform an initial relative accuracy test of the flow rate monitoring system according to section 8.2 of Performance Specification 6 of appendix B to part 60 of the chapter with the exceptions in paragraphs (g)(3)(vii)(A) and (B) of this section.
(A) The relative accuracy test is to evaluate the flow rate monitoring system alone rather than a continuous emission rate monitoring system.
(B) The relative accuracy of the flow rate monitoring system shall be no greater than 10 percent of the mean value of the reference method data.
(viii) You must verify the accuracy of the flow rate monitoring system at least once per year by repeating the relative accuracy test specified in paragraph (g)(3)(vii) of this section.
(ix) You must operate the flow rate monitoring system and record data during all periods of operation of the affected facility including periods of startup, shutdown, and malfunction.
(4) Pressure differential monitor. You must instead install, operate, calibrate, and maintain a continuous pressure differential monitoring system, as follows, to verify the presence of PTE. You must operate this system whenever the facility is in operation. You must also maintain the pressure differential at or above 0.007 inches of water over a three-hour rolling average.
(i) This monitoring system must measure the pressure differential between the interior and exterior of the PTE, with at least one monitoring device located in each room that borders the PTE. These monitoring devices shall be designed to provide measurements of pressure differential to at least the nearest 0.001 inches of water and having a complete cycle time no greater than 5 minutes.
(ii) A data acquisition system for the monitoring system shall compute and record each 3-hour average pressure differential value, rolled hourly. This must be done by first averaging the pressure differential readings over a clock hour, i.e., beginning and ending on the hour. All data collected during the operating hour must be used, even in portions of the facility covered by PTE that are not operated for a complete hour. Then, the average of the previous 3 operating hours must be calculated to determine the 3-hour rolling average pressure differential. If data are not recorded from an alternative monitoring device, during any malfunction of the principal monitoring device(s) or the automatic recorder, you must manually record the measured data at least hourly.
(h) Sterilization chamber end-cycle EtO concentration. As part of your monitoring plan, you must document your approach for determining the EtO sterilization chamber concentration. If you choose a parametric approach you must meet the requirements in paragraph (h)(1) of this section and if you choose a direct measurement approach you must meet the requirements in paragraph (h)(2) of this section. Alternatively, you may petition the administrator for an alternative monitoring approach under § 63.8(f).
(1) If you choose a parametric approach for determining chamber EtO concentrations you must document parameter(s) used in the calculation to determine of EtO concentrations and the calculation(s) used to determine the chamber concentration. Any instrumentation used for parametric monitoring must also be identified in the monitoring plan and at a minimum this plan should include the following for each instrument:
(i) Parameter measured and measurement principle of the monitor.
(ii) Instrument name, model number, serial number, and range.
(iii) Manufacturer recommended operation practices, including daily operational check.
(iv) Procedures for calibration, the frequency of calibration, and accuracy requirements of the calibration.
(v) Description for how the information from the parameter monitor is being collected and stored.
(2) If you choose a direct measurement approach for determining chamber EtO calibrations you must document the procedures used for the operation of the instruments. Any instrument used for direct measurement of EtO must be identified in the monitoring plan and at a minimum this plan must include the following information:
(i) Instrument name, model number, serial number, and range.
(ii) Description of the measurement principle and any potential interferences.
(iii) If applicable, the description of the sampling condition system.
(iv) Procedures for calibration, the frequency of calibration, and accuracy requirements of the calibration.
(v) Description for how the information from the parameter monitor is being collected and stored.
(i) EtO usage. If you own or operate a sterilization facility subject to the requirements of this subpart you must monitor and record on a daily basis the daily and 30-operating day EtO usage according to the requirements of this paragraph. Additionally, you must record EtO usage for each calendar month.
(1) Monitor and record on a daily basis, the daily total mass of ethylene oxide, in pounds, used at the facility. The daily total mass must be determined using the methodology specified in § 63.365(c)(1)(i) and (ii).
(2) Determine and record daily the 30-operating day rolling ethylene oxide usage rate using equation 6 to this paragraph.
(3) Determine and record the total mass of EtO used in each calendar month.
§ 63.365   Test methods and procedures.
(a) General —(1) Performance testing for facility where EtO use is less than 100 pounds per year. If you own or operate an affected source at a facility where EtO use is less than 100 lb/yr that is subject to an emission standard in § 63.362, you must comply with the performance testing requirements in § 63.7, according to the applicability in table 6 to this subpart, using the methods in paragraph (b) or (c) of this section, following the applicable procedures for initial compliance and continuous compliance in paragraphs (d), (e), and (f) of this section.
(2) Facilities subject to capture efficiency. If you are subject to capture efficiency requirements in § 63.362, you must follow the applicable procedures for initial and continuous compliance in paragraph (f) of this section.
(b) Test methods for facility where EtO use is less than 100 pounds per year. You must use the following test methods to determine the average mass emissions of EtO in lb/hr at the inlet of a control system (M APCD, i ) and/or outlet of a control system or stack (E APCD, o ).
(1) Select the location of the sampling ports and the number of traverse points according to Method 1 of appendix A-1 to part 60 of this chapter. Alternatively, for ducts less than 0.3 meter (12 in.) in diameter, you may choose to locate sample ports according to Method 1A of appendix A-1 to part 60 of this chapter.
(2) Determine the flow rate through the control system exhaust(s) continuously during the test period according to either Methods 2, 2A, or 2C of appendix A-1 to part 60 of this chapter, as appropriate. If using Method 2, 2A, or 2C, you must complete velocity traverses immediately before and subsequently after each test run. If your test run is greater than 1 hour, you must also complete a velocity traverse at least every hour. Average the velocity collected during a test run and calculate volumetric flow as outlined in the appropriate method.
(3) Determine the oxygen and carbon dioxide concentration of the effluent according to Method 3A or 3B of appendix A-2 to part 60 of this chapter. The manual procedures (but not instrumental procedures) of voluntary consensus standard ANSI/ASME PTC 19.10-1981 (incorporated by reference, see § 63.14) may be used as an alternative to EPA Method 3B.
(4) Determine the moisture content of the stack gas according to Method 4 of appendix A-3 to part 60 of this chapter. Alternatively, you may use an on-line technique that has been validated using Method 301 of appendix A to this part.
(5) Determine the EtO concentration according to either paragraph (b)(5)(i) or (ii) of this section.
(i) Follow Method 320 of appendix A to this part and the following paragraphs (5)(i)(A) through (D).
(A) The instrumentation used for measurement must have the measurement range to properly quantify the EtO in the gas stream. Additionally, for outlet emission streams, the instrumentation must have a method detection limit an order of magnitude below concentration equivalent of the emission limit.
(B) Instrumentation used must be continuous in nature with an averaging time of one minute or less.
(C) Calibration Spectra and all other analyte spiking required in the method must use EtO gaseous cylinder standard(s) which meet the criteria found in Performance Specification 19 of appendix B to part 60 if this chapter.
(D) Other methods and materials may be used; however, these alternative test methods are subject to Administrator approval.
(ii) Alternatively, ASTM D6348-12 (Reapproved 2020), (incorporated by reference, see § 63.14) may be used with the following conditions:
(A) The test plan preparation and implementation in the Annexes to ASTM D 6348-12 (R2020), Sections A1 through A8 are mandatory; and
(B) In ASTM D6348-12 (R2020) Annex A5 (Analyte Spiking Technique), the percent (%) R must be determined for each target analyte (equation A5.5). In order for the test data to be acceptable for a compound, %R must be 70% ≥ R ≤ 130%. If the %R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the test must be repeated for that analyte ( i.e., the sampling and/or analytical procedure should be adjusted before a retest). The %R value for each compound must be reported in the test report, and all field measurements must be corrected with the calculated %R value for that compound by using equation 1 to this paragraph:
(6) Calculate the mass emission of EtO by using equations 2 and 3 to this paragraph:
(c) Alternative approach for SCVs for facility where EtO use is less than 100 pounds per year. If you do not own or operate a single-item sterilizer, to demonstrate compliance with the percent emission reduction standards for emissions streams that are comprised only of SCVs, you may use the following procedures as an alternative to paragraph (b) of this section to determine the mass emissions of EtO being emitted via sterilization chamber(s) vents prior to the controls.
(1) Determine the mass (M SCV,n ) of EtO used for each charge and at each sterilization chamber used during the performance tests using the procedures in either paragraph (c)(1)(i) or (ii) of this section.
(i) Weigh the EtO gas cylinder(s) used to charge the sterilizer(s) before and after charging. Record these weights to the nearest 45 g (0.1 lb) and calculate the theoretical mass (M SCV,n ) vented to the controls using equation 4 to this paragraph.
(ii) Install a calibrated rate meter at the sterilizer inlet(s) and continuously measure the flow rate (Q m ) and duration of each sterilizer charge. Calculate the theoretical mass (M SCV,n ) vented to the controls using equation 5 to this paragraph.
(2) Determine the mass rate of EtO sent to controls during the performance test using equation 6 to this paragraph.
(d) Compliance determination for facility where EtO use is less than 100 pounds per year. Each compliance demonstration shall consist of three separate runs using the applicable methods in paragraph (b) or (c) of this section. To determine compliance with the relevant standard, arithmetic mean of the three runs must be used. These procedures may be performed over a run duration of 1-hour (for a total of three 1-hour runs), except for the SCV testing from this category, where each run shall consist of the entirety of the sterilizer chamber evacuation and subsequent washes. The owner or operator may not conduct performance tests during periods of malfunction. The owner or operator must record the process information that is necessary to document operating conditions during the test and include in such record an explanation to support that such conditions represent the entire range of normal operation, including operational conditions for maximum emissions if such emissions are not expected during maximum production. The owner or operator must also account for the control system residence time when conducting the performance test. Upon request, the owner or operator shall make available to the Administrator such records as may be necessary to determine the conditions of performance tests. The following procedures shall be used to demonstrate compliance with a removal efficiency standard. In addition to these procedures, the procedures in paragraph (e) of this section must be followed to establish the operating parameter limits for each applicable emission control(s).
(1) You may determine the mass rate emissions of the stream prior to the control system and at the outlet of the control system using the test methods in paragraph (b) of this section. If the vent stream is comprised only of one or more SCVs, then you may use the procedures in paragraph (c) of this section for the mass rate emissions at the inlet.
(2) Calculate the total mass of EtO per hour that is routed to the control system by summing the mass of EtO per hour from each vent.
(3) Determine percent emission reduction (%ER) using the equation 7 to this paragraph:
(4) Repeat these procedures two additional times. The arithmetic average percent efficiency of the three runs shall determine the overall efficiency of the control system.
(e) Determination of operating limits for control device(s). If you are using performance testing to demonstrate compliance with removal efficiency standards, and if you are not demonstrating continual compliance with the applicable standard(s) using an EtO CEMS, you must also determine the operating limit(s) for each control device and then monitor the parameter(s) for each control device. The procedures in the following paragraphs shall be used to establish the parameter operating limits to be continually monitored in § 63.364.
(1) Acid-water scrubbers. The procedures in paragraph (e)(1) of this section shall be used to determine the operating limits for acid-water scrubbers.
(i) Ethylene glycol concentration. For determining the ethylene glycol concentration operating limit, you must establish the maximum ethylene glycol concentration as the ethylene glycol concentration averaged over three test runs; use the sampling and analysis procedures in ASTM D3695-88 (incorporated by reference, see § 63.14) to determine the ethylene glycol concentration.
(ii) Scrubber liquor tank level. During the performance test, you must monitor and record the scrubber liquor tank level to the nearest 1/4 inch at the end of each of the three test runs. Use the data collected during the most recent performance test to calculate the average scrubber liquor tank level. This scrubber liquor tank level is the maximum operating limit for your scrubber liquor tank. Repeat this procedure for every scrubber liquor tank that is included in the performance test.
(iii) Scrubber liquor pH. During the performance test, you must monitor and record the scrubber liquor pH at least once every 15 minutes during each of the three test runs. You must use pH monitors as described in § 63.364(b)(3). Use the data collected during the most recent performance test to calculate the average scrubber pH measured. This scrubber liquor pH is the maximum operating limit for your acid-water scrubber. Repeat this procedure for every scrubber liquor tank that is included in the performance test.
(2) Thermal oxidizers. The procedures in this paragraph shall be used to determine the operating limits for thermal oxidizers.
(i) During the performance test, you must monitor and record the temperature at least once every 15 minutes during each of the three test runs. You must monitor the temperature in the firebox of the thermal oxidizer or immediately downstream of the firebox. You must use temperature monitors as described in § 63.364(c)(4).
(ii) Use the data collected during the performance test to calculate and record the average temperature for each test run maintained during the performance test. The average temperature of the test runs is the minimum operating limit for your thermal oxidizer, unless it exceeds the recommended maximum oxidation temperature provided by the oxidation unit manufacturer. If this occurs, the minimum operating limit for your thermal oxidizer consists of the recommended maximum oxidation temperature provided by the oxidation unit manufacturer.
(iii) Paragraphs (e)(2)(i) and (ii) of this section must be completed for each thermal oxidizer that is involved in the performance test.
(3) Catalytic oxidizers. The procedures in this paragraph shall be used to determine the operating limits for catalytic oxidizers.
(i) Prior to the start of the performance test, you must check the catalyst bed for channeling, abrasion, and settling. If problems are found during the inspection, you must replace the catalyst bed or take other correction action consistent with the manufacturer's recommendations.
(ii) During the performance test, you must monitor and record the temperature at the inlet to the catalyst bed and the temperature difference across the catalyst bed at least once every 15 minutes during each of the three test runs. You must use temperature monitors as described in § 63.364(c)(4).
(iii) Use the data collected during the performance test to calculate and record the average temperature at the inlet to the catalyst bed and the average temperature difference across the catalyst bed maintained for each test run, and then calculate the arithmetic averages of the test runs. These arithmetic averages of the test runs are the minimum operating limits for your catalytic oxidizer, unless it exceeds the recommended maximum oxidation temperature provided by the oxidation unit manufacturer. If this occurs, the minimum operating limit for your catalytic oxidizer consists of the recommended maximum oxidation temperature provided by the oxidation unit manufacturer.
(iv) Paragraphs (e)(3)(i) through (iii) of this section must be completed for each catalytic oxidizer that is involved in the performance test.
(4) Gas/solid reactors. During the performance test, you must monitor and record the gas/solid reactor pressure drop at least once every 15 minutes during each of the three test runs. Use the data collected during the most recent performance test to calculate the gas/solid reactor pressure measured. This gas/solid reactor pressure is the maximum operating limit for your gas/solid. Repeat this procedure for every gas/solid reactor that is included in the performance test.
(5) Other control system for facility where EtO use is less than 100 pounds per year. If you seek to demonstrate compliance with a standard found at § 63.362 with a control device other than an acid-water scrubber, catalytic oxidizer, thermal oxidizer, or gas/solid reactor, you must provide to the Administrator the information requested under § 63.363(e). You must submit a monitoring plan that contains the following items: a description of the device; test results collected in accordance with § 63.363(e) verifying the performance of the device for controlling EtO emissions to the atmosphere to the levels required by the applicable standards; the appropriate operating parameters that will be monitored, identifying the ongoing QA procedures and performance specifications that will be conducted on the instruments; the frequency of conducting QA and performance checks; and the frequency of measuring and recording to establish continuous compliance with the standards. Your monitoring plan is subject to the Administrator's approval. Upon approval by the Administrator you must install, calibrate, operate, and maintain the monitor(s) approved by the Administrator based on the information submitted in your monitoring plan. You must include in your monitoring plan proposed performance specifications and quality assurance procedures for your monitors. The Administrator may request further information and shall approve appropriate test methods and procedures.
(f) Determination of compliance with PTE requirement. If you are required to operate any portion of your facility with PTE, you must demonstrate initial compliance with the requirements of this subpart by following the procedures of paragraphs (f)(1) through (3) of this section, as applicable, during the initial compliance demonstration or during the initial certification of the CEMS tests.
(1) Determine the capture efficiency by verifying the capture system meets the criteria in section 6 of Method 204 of appendix M to part 51 of this chapter and directs all the exhaust gases from the enclosure to an add-on control device.
(2) Ensure that the air passing through all NDOs flows into the enclosure continuously. If the facial velocities (FVs) are less than or equal to 9,000 meters per hour (492 feet per minute), the continuous inward flow of air shall be verified by continuous observation using smoke tubes, streamers, tracer gases, or other means approved by the Administrator over the period that the volumetric flow rate tests required to determine FVs are carried out. If the FVs are greater than 9,000 meters per hour (492 feet per minute), the direction of airflow through the NDOs shall be presumed to be inward at all times without verification.
(3) If you are demonstrating continuous compliance through monitoring the volumetric flow rate, you must monitor and record the volumetric flow rate (in cubic feet per second) from the PTE through the stack(s) at least once every 15 minutes during each of the three test runs. Use the data collected during the most recent compliance demonstration to calculate the average volumetric flow rate measured during the compliance demonstration. This volumetric flow rate is the minimum operating limit for the stack. Repeat this procedure for every stack that is included in the compliance demonstration.
§ 63.366   Reporting requirements.
(a) General requirements. The owner or operator of an affected source subject to the emissions standards in § 63.362 must fulfill all reporting requirements in § 63.10(a), (d), (e), and (f), according to the applicability in table 6 to this subpart. These reports will be made to the Administrator at the appropriate address identified in § 63.13 or submitted electronically.
(b) Initial compliance report submission. You must submit an initial compliance report that provides summary, monitoring system performance, and deviation information to the Administrator on April 5, 2027, or once the report template for this subpart has been available on the Compliance and Emissions Data Reporting Interface (CEDRI) website for one year, whichever date is later, to the EPA via CEDRI, which can be accessed through the EPA's Central Data Exchange (CDX) ( https://cdx.epa.gov/ ). The EPA will make all the information submitted through CEDRI available to the public without further notice to you. Do not use CEDRI to submit information you claim as confidential business information (CBI). Anything submitted using CEDRI cannot later be claimed CBI. You must use the appropriate electronic report template on the CEDRI website ( https://www.epa.gov/electronic-reporting-air-emissions/cedri ) for this subpart. The date report templates become available will be listed on the CEDRI website. The report must be submitted by the deadline specified in this subpart, regardless of the method in which the report is submitted. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim, submit a complete report, including information claimed to be CBI, to the EPA. The CBI report must be generated using the appropriate form on the CEDRI website or an alternate electronic file consistent with the extensible markup language (XML) schema listed on the CEDRI website. Submit the CBI file on a compact disc, flash drive, or other commonly used electronic storage medium and clearly mark the medium as CBI. Mail the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Commercial Sterilization Facilities Sector Lead, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described earlier in this paragraph. All CBI claims must be asserted at the time of submission. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available. Reports of deviations from an operating limit shall include all information required in § 63.10(c)(5) through (13), as applicable in table 6 to this subpart, along with information from any calibration tests in which the monitoring equipment is not in compliance with Performance Specification 19 in appendix B and Procedure 7 in appendix F to part 60 of this chapter or the method used for parameter monitoring device calibration. Reports shall also include the name, title, and signature of the responsible official who is certifying the accuracy of the report. If your report is submitted via CEDRI, the certifier's electronic signature during the submission process replaces this requirement. When no deviations have occurred or monitoring equipment has not been inoperative, repaired, or adjusted, such information shall be stated in the report. In addition, the summary report shall include:
(1) The following information:
(i) Date that facility commenced construction or reconstruction;
(ii) Hours of commercial sterilization operation over the previous 12 months; and
(iii) Monthly EtO use, in tons, over the previous 36 months.
(iv) If you are electing to determine the mass of EtO sent to the control device from the SCV(s) via the procedure in § 63.364(f)(1)(i), you must report the daily EtO use from each applicable chamber for the previous 7 months.
(v) An indication if you are required to comply with one or more combined emission stream limitations. If so, indicate the affected sources that are included in each combined emission stream limitation.
(vi) An indication if you are electing to comply with a site-wide emission limit. If you are electing to comply with a site-wide emission limit, report the daily EtO use over the previous 7 months.
(2) If your sterilization facility is demonstrating continuous compliance through periodic performance testing, you must report the following:
(i) Control system ID;
(ii) Control device ID;
(iii) Control device type; and
(iv) Recirculation tank ID if an acid-water scrubber is used to meet the emission standard and you elect to comply with the maximum scrubber liquor height limit;
(3) You must report the following for each sterilization chamber at your facility:
(i) The sterilization chamber ID;
(ii) The ID of the control system that the SCV was routed to, if applicable;
(iii) The portion of SCV exhaust that was routed to the control system, if applicable;
(iv) The ID of the EtO CEMS that was used to monitor SCV emissions, if applicable;
(v) The portion of SCV exhaust that was monitored with the EtO CEMS, if applicable;
(vi) The ID of the control system that the CEV was routed to, if applicable;
(vii) The portion of CEV exhaust that was routed to the control system, if applicable;
(viii) The ID of the EtO CEMS that was used to monitor CEV emissions, if applicable;
(ix) The portion of CEV exhaust that was monitored with the EtO CEMS, if applicable;
(4) If emissions from any room in your facility are subject to an emission standard, you must report the following for each room where there is the potential for EtO emissions:
(i) Room ID;
(ii) Documentation of emissions occurring within the room, including aeration, EtO storage, EtO dispensing, pre-aeration handling of sterilized material, and post-aeration handling of sterilized material;
(iii) The ID of the control system that the room air was routed to, if applicable;
(iv) The portion of room air that was routed to the control system, if applicable;
(v) The ID of the EtO CEMS that was used to monitor room air emissions, if applicable;
(vi) The portion of room air that was monitored with the EtO CEMS, if applicable;
(5) If an EtO CEMS was used to demonstrate continuous compliance with an emission standard for more than 30-operating days, you must report the following:
(i) The information specified in section 11 of appendix A to this subpart.
(ii) The affected sources that are included in each inlet that is being monitored with EtO CEMS;
(iii) The IDs of each inlet(s) to and outlet(s) from each control system.
(iv) The daily sum of EtO for each inlet, along with 30-operating day rolling sums.
(v) The daily sum of EtO emissions from each outlet of the control system, along with 30-operating day rolling sums.
(vi) For each day, calculate and report the daily mass emission limit that the control system must achieve based on the previous 30 days of data. For control systems with multiple emission streams, and complying with a combined emission stream limitation in § 63.362(i) or a SWEL in § 63.362(j), report the daily 30-operating day mass emission limit as determined in accordance with CES in § 63.362(i)(1)(i) and (i)(2)(i) or with § 63.362(j)(1)(i) and (j)(2)(i), as applicable.
(vii) For each day, the mass of EtO emitted from the control system over the previous 30 operating days.
(6) If any portion of your facility is required to be operated with PTE, you must report the following:
(i) If you are choosing to demonstrate continuous compliance through the use of volumetric flow rate monitoring, you must report the 3-hr rolling average, rolled hourly volumetric flow from each outlet where air from the PTE is sent, in cubic feet per second.
(ii) If you are choosing to demonstrate continuous compliance through use of differential pressure monitoring, you must report the 3-hr rolling average, rolled hourly pressure differential reading, in inches water.
(7) If you are complying with the requirement to follow the best management practice to limit sterilization chamber concentration of EtO to 1 ppmv prior to opening the sterilization chamber door, you must provide a certification from your responsible official that this approach is being followed and you are meeting the monitoring requirements at § 63.362(h).
(8) If you own or operate an existing collection of Group 2 room air emissions at an area source facility and facility EtO use is less than 4 tpy, you must report the following for each room where there are Group 2 room air emissions:
(i) Room ID;
(ii) Number of room air changes per hour;
(iii) Room temperature, in degrees Celsius; and
(iv) EtO concentration, in ppmv dry basis (ppbvd).
(9) If you own or operate an existing collection of Group 2 room air emissions at an area source facility and EtO use is less than 4 tpy, you are not required to report the information in paragraph (b)(8) of this section if you meet the following requirements:
(i) You are complying with the best management practice to limit sterilization chamber concentration of EtO to 1 ppmv prior to opening the sterilization chamber door; and
(ii) The requirements of § 63.363 are met.
(10) Report the number of deviations to meet an applicable standard. For each instance, report the date, time, the cause and duration of each deviation. For each deviation the report must include a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to determine the emissions.
(c) Quarterly compliance report submission. You must submit compliance reports that provide summary, monitoring system performance, and deviation information to the Administrator within 30 days following the end of each calendar quarter. Beginning on April 5, 2027, or once the report template for this subpart has been available on the Compliance and Emissions Data Reporting Interface (CEDRI) website for 1 year, whichever date is later, submit all subsequent reports to the EPA via CEDRI, which can be accessed through the EPA's CDX ( https://cdx.epa.gov/ ). The EPA will make all the information submitted through CEDRI available to the public without further notice to you. Do not use CEDRI to submit information you claim as CBI. Anything submitted using CEDRI cannot later be claimed CBI. You must use the appropriate electronic report template on the CEDRI website ( https://www.epa.gov/electronic-reporting-air-emissions/cedri ) for this subpart. The date report templates become available will be listed on the CEDRI website. The report must be submitted by the deadline specified in this subpart, regardless of the method in which the report is submitted. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim, submit a complete report, including information claimed to be CBI, to the EPA. The CBI report must be generated using the appropriate form on the CEDRI website or an alternate electronic file consistent with the XML schema listed on the CEDRI website. Submit the CBI file on a compact disc, flash drive, or other commonly used electronic storage medium and clearly mark the medium as CBI. Mail the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Commercial Sterilization Facilities Sector Lead, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described earlier in this paragraph. All CBI claims must be asserted at the time of submission. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Reports of deviations from an operating limit shall include all information required in § 63.10(c)(5) through (13), as applicable in table 6 to this subpart, and information from any calibration tests in which the monitoring equipment is not in compliance with Performance Specification 19 in appendix B and Procedure 7 in appendix F to part 60 of this chapter or the method used for parameter monitoring device calibration. Reports shall also include the name, title, and signature of the responsible official who is certifying the accuracy of the report. If your report is submitted via CEDRI, the certifier's electronic signature during the submission process replaces this requirement. When no deviations have occurred or monitoring equipment has not been inoperative, repaired, or adjusted, such information shall be stated in the report. In addition, the summary report shall include:
(1) The information listed in paragraphs (b)(1)(i) through (vi) of this section, with the exception that monthly EtO use, in tons, only needs reported for the previous 12 months;
(2) If your sterilization facility is demonstrating continuous compliance through periodic performance testing, you must report the ID for any control system that has not operated since the end of the period covered by the previous compliance report. If a control system has commenced operation since end of the period covered by the previous compliance report, or if any of the information in paragraphs (b)(2)(i) through (iv) of this section has changed for a control system that was included in the previous compliance report, you must report the information in paragraphs (b)(2)(i) through (iv) of this section for those control systems;
(3) You must report the ID for any sterilization chamber that has not operated since then end of the period covered by the previous compliance report. If a sterilization chamber has commenced operation since the end of the period covered by the previous compliance report, or if any of the information in paragraphs (b)(3)(i) through (ix) of this section has changed for a sterilization chamber that was included in the previous compliance report, you must report the information in paragraphs (b)(3)(i) through (ix) of this section for those sterilization chambers;
(4) If emissions from any room in your facility are subject to an emission standard, you must report the ID for any room where there has not been the potential for EtO emissions since the end of the period covered by the previous compliance report. If a room has had the potential for EtO emissions since the end of the period covered by the previous compliance report, or if any of the information in paragraphs (b)(4)(i) through (vi) of this section has changed for a room where there is the potential for EtO emissions that was included in the previous compliance report, you must report the information in paragraphs (b)(4)(i) through (vi) of this section for those rooms;
(5) If an EtO CEMS was used to demonstrate continuous compliance, you must report the information specified in paragraphs (b)(5)(i) through (vi) of this section.
(6) If any portion of your facility is required to be operated with PTE, you must report the information listed in paragraph (b)(6) of this section.
(7) If you are complying with the requirement to follow the best management practice to limit sterilization chamber concentration of EtO to 1 ppmv prior to opening the sterilization chamber door, you must provide a certification from your responsible official that this approach is being followed and you are meeting the monitoring requirements at § 63.362(h).
(8) If you own or operate an existing collection of Group 2 room air emissions at an area source facility and facility EtO use is less than 4 tpy, you must report the ID for any room where Group 2 room air emissions have ceased since end of the period covered by the previous compliance report. If a room has had Group 2 room air emissions since the end of the period covered by the previous compliance report, or if any of the information in paragraphs (b)(8)(i) through (iv) of this section has changed for a room where there are Group 2 room air emissions that were included in the previous compliance report, you must report the information in paragraphs (b)(8)(i) through (iv) of this section for each room where there are Group 2 room air emissions.
(9) If you own or operate an existing collection of Group 2 room air emissions at an area source facility and facility EtO use is less than 4 tpy, you are not required to report the information in paragraph (c)(8) of this section if you meet the requirements in paragraph (b)(9) of this section.
(10) Report the number of deviations to meet an applicable standard. For each instance, report the date, time, the cause, and duration of each deviation. For each deviation, the report must include a list of the affected sources or equipment, the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to determine the emissions.
(d) Construction and reconstruction application. You must fulfill all requirements for construction or reconstruction of a facility in § 63.5, according to the applicability in table 6 to this subpart, and in this paragraph.
(1) Applicability. (i) This paragraph (d) and § 63.5 implement the preconstruction review requirements of section 112(i)(1) for facilities subject to these emissions standards. In addition, this paragraph (d) and § 63.5 include other requirements for constructed and reconstructed facilities that are or become subject to these emissions standards.
(ii) After April 5, 2024, the requirements in this section and in § 63.5 apply to owners or operators who construct a new facility or reconstruct a facility subject to these emissions standards after April 5, 2024. New or reconstructed facilities subject to these emissions standards with an initial startup date before the effective date are not subject to the preconstruction review requirements specified in paragraphs (b)(2) and (3) of this section and § 63.5(d)(3) and (4) and (e).
(2) Advance approval. After April 5, 2024, whether or not an approved permit program is effective in the jurisdictional authority in which a facility is (or would be) located, no person may construct a new facility or reconstruct a facility subject to these emissions standards, or reconstruct a facility such that the facility becomes a facility subject to these emissions standards, without obtaining advance written approval from the Administrator in accordance with the procedures specified in paragraph (b)(3) of this section and § 63.5(d)(3) and (4) and (e).
(3) Application for approval of construction or reconstruction. The provisions of paragraph (b)(3) of this section and § 63.5(d)(3) and (4) implement section 112(i)(1) of the Act.
(i) General application requirements. (A) An owner or operator who is subject to the requirements of paragraph (b)(2) of this section shall submit to the Administrator an application for approval of the construction of a new facility subject to these emissions standards, the reconstruction of a facility subject to these emissions standards, or the reconstruction of a facility such that the facility becomes a facility subject to these emissions standards. The application shall be submitted as soon as practicable before the construction or reconstruction is planned to commence (but not sooner than the effective date) if the construction or reconstruction commences after the effective date. The application shall be submitted as soon as practicable before the initial startup date but no later than 60 days after the effective date if the construction or reconstruction had commenced and the initial startup date had not occurred before the effective date. The application for approval of construction or reconstruction may be used to fulfill the initial notification requirements of paragraph (e)(1)(iii) of this section. The owner or operator may submit the application for approval well in advance of the date construction or reconstruction is planned to commence in order to ensure a timely review by the Administrator and that the planned commencement date will not be delayed.
(B) A separate application shall be submitted for each construction or reconstruction. Each application for approval of construction or reconstruction shall include at a minimum:
( 1 ) The applicant's name and address.
( 2 ) A notification of intention to construct a new facility subject to these emissions standards or make any physical or operational change to a facility subject to these emissions standards that may meet or has been determined to meet the criteria for a reconstruction, as defined in § 63.2.
( 3 ) The address ( i.e., physical location) or proposed address of the facility.
( 4 ) An identification of the relevant standard that is the basis of the application.
( 5 ) The expected commencement date of the construction or reconstruction.
( 6 ) The expected completion date of the construction or reconstruction.
( 7 ) The anticipated date of (initial) startup of the facility.
( 8 ) The type and quantity of hazardous air pollutants emitted by the facility, reported in units and averaging times and in accordance with the test methods specified in the standard, or if actual emissions data are not yet available, an estimate of the type and quantity of hazardous air pollutants expected to be emitted by the facility reported in units and averaging times specified. The owner or operator may submit percent reduction information, if the standard is established in terms of percent reduction. However, operating parameters, such as flow rate, shall be included in the submission to the extent that they demonstrate performance and compliance.
( 9 ) Other information as specified in paragraph (b)(3)(ii) of this section and § 63.5(d)(3).
(C) An owner or operator who submits estimates or preliminary information in place of the actual emissions data and analysis required in paragraphs (b)(3)(i)(B)( 8 ) and (b)(3)(ii) of this section shall submit the actual, measured emissions data and other correct information as soon as available but no later than with the notification of compliance status required in paragraph (c)(2) of this section.
(ii) Application for approval of construction. Each application for approval of construction shall include, in addition to the information required in paragraph (b)(3)(i)(B) of this section, technical information describing the proposed nature, size, design, operating design capacity, and method of operation of the facility subject to these emissions standards, including an identification of each point of emission for each hazardous air pollutant that is emitted (or could be emitted) and a description of the planned air pollution control system (equipment or method) for each emission point. The description of the equipment to be used for the control of emissions shall include each control device for each hazardous air pollutant and the estimated control efficiency (percent) for each control device. The description of the method to be used for the control of emissions shall include an estimated control efficiency (percent) for that method. Such technical information shall include calculations of emission estimates in sufficient detail to permit assessment of the validity of the calculations. An owner or operator who submits approximations of control efficiencies under paragraph (b)(3) of this section shall submit the actual control efficiencies as specified in paragraph (b)(3)(i)(C) of this section.
(4) Approval of construction or reconstruction based on prior jurisdictional authority preconstruction review. (i) The Administrator may approve an application for construction or reconstruction specified in paragraphs (b)(2) and (3) of this section and § 63.5(d)(3) and (4) if the owner or operator of a new or reconstructed facility who is subject to such requirement demonstrates to the Administrator's satisfaction that the following conditions have been (or will be) met:
(A) The owner or operator of the new or reconstructed facility subject to these emissions standards has undergone a preconstruction review and approval process in the jurisdictional authority in which the facility is (or would be) located before the effective date and has received a federally enforceable construction permit that contains a finding that the facility will meet these emissions standards as proposed, if the facility is properly built and operated;
(B) In making its finding, the jurisdictional authority has considered factors substantially equivalent to those specified in § 63.5(e)(1).
(ii) The owner or operator shall submit to the Administrator the request for approval of construction or reconstruction no later than the application deadline specified in paragraph (b)(3)(i) of this section. The owner or operator shall include in the request information sufficient for the Administrator's determination. The Administrator will evaluate the owner or operator's request in accordance with the procedures specified in § 63.5. The Administrator may request additional relevant information after the submittal of a request for approval of construction or reconstruction.
(e) Notification requirements. The owner or operator of an affected source subject to an emissions standard in § 63.362 shall fulfill all notification requirements in § 63.9, according to the applicability in table 6 to this subpart, and in this paragraph (e).
(1) Initial notifications. (i) If you own or operate an affected source subject to an emissions standard in § 63.362, you may use the application for approval of construction or reconstruction under paragraph (d)(3)(ii) of this section and § 63.5(d)(3), respectively, if relevant to fulfill the initial notification requirements.
(ii) The owner or operator of a new or reconstructed facility subject to these emissions standards that has an initial startup date after the effective date and for which an application for approval of construction or reconstruction is required under paragraph (d)(3) of this section and § 63.5(d)(3) and (4) shall provide the following information in writing to the Administrator:
(A) A notification of intention to construct a new facility subject to these emissions standards, reconstruct a facility subject to these emissions standards, or reconstruct a facility such that the facility becomes a facility subject to these emissions standards with the application for approval of construction or reconstruction as specified in paragraph (d)(3)(i)(A) of this section;
(B) A notification of the date when construction or reconstruction was commenced, submitted simultaneously with the application for approval of construction or reconstruction, if construction or reconstruction was commenced before the effective date of these standards;
(C) A notification of the date when construction or reconstruction was commenced, delivered or postmarked no later than 30 days after such date, if construction or reconstruction was commenced after the effective date of these standards;
(D) A notification of the anticipated date of startup of the facility, delivered or postmarked not more than 60 days nor less than 30 days before such date; and
(E) A notification of the actual date of initial startup of the facility, delivered or postmarked within 15 calendar days after that date.
(iii) After the effective date, whether or not an approved permit program is effective in the jurisdictional authority in which a facility subject to these emissions standards is (or would be) located, an owner or operator who intends to construct a new facility subject to these emissions standards or reconstruct a facility subject to these emissions standards, or reconstruct a facility such that it becomes a facility subject to these emissions standards, shall notify the Administrator in writing of the intended construction or reconstruction. The notification shall be submitted as soon as practicable before the construction or reconstruction is planned to commence (but no sooner than the effective date of these standards) if the construction or reconstruction commences after the effective date of the standard. The notification shall be submitted as soon as practicable before the initial startup date but no later than 60 days after the effective date of this standard if the construction or reconstruction had commenced and the initial startup date has not occurred before the standard's effective date. The notification shall include all the information required for an application for approval of construction or reconstruction as specified in paragraph (d)(3) of this section and § 63.5(d)(3) and (4). For facilities subject to these emissions standards, the application for approval of construction or reconstruction may be used to fulfill the initial notification requirements of § 63.9.
(2) If an owner or operator of a facility subject to these emissions standards submits estimates or preliminary information in the application for approval of construction or reconstruction required in paragraph (d)(3)(ii) of this section and § 63.5(d)(3), respectively, in place of the actual emissions data or control efficiencies required in paragraphs (d)(3)(i)(B)( 8 ) and (b)(3)(ii) of this section, the owner or operator shall submit the actual emissions data and other correct information as soon as available but no later than with the initial notification of compliance status.
(3) If you own or operate an affected source subject to an emissions standard in § 63.362, you must also include the amount of EtO used at the facility during the previous consecutive 12-month period in the initial notification report required by § 63.9(b)(2) and (3). For new sterilization facilities subject to this subpart, the amount of EtO used at the facility shall be an estimate of expected use during the first consecutive 12-month period of operation.
(4) Beginning October 7, 2024, you must submit all subsequent Notification of Compliance Status reports in PDF formatto the EPA following the procedure specified in § 63.9(k), except any medium submitted through mail must be sent to the attention of the Commercial Sterilization Sector Lead.
(f) Performance test submission. Beginning on June 4, 2024, within 60 days after the date of completing each performance test required by this subpart, you must submit the results of the performance test following the procedures specified in paragraphs (f)(1) through (3) of this section.
(1) Data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert) at the time of the test. Submit the results of the performance test to the EPA via the CEDRI, which can be accessed through the EPA's CDX ( https://cdx.epa.gov/ ). The data must be submitted in a file format generated using the EPA's ERT. Alternatively, you may submit an electronic file consistent with the XML schema listed on the EPA's ERT website.
(2) Data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the test. The results of the performance test must be included as an attachment in the ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the ERT generated package or alternative file to the EPA via CEDRI.
(3) CBI. Do not use CEDRI to submit information you claim as CBI. Anything submitted using CEDRI cannot later be claimed CBI. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim for some of the information submitted under paragraph (f)(1)(i) or (ii) of this section, you must submit a complete file, including information claimed to be CBI, to the EPA. The file must be generated using the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the file on a compact disc, flash drive, or other commonly used electronic storage medium and clearly mark the medium as CBI. Mail the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described in paragraphs (f)(1)(i) and (ii) of this section. All CBI claims must be asserted at the time of submission. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available.
(g) Performance evaluation submission. Beginning on June 4, 2024, within 60 days after the date of completing each CEMS performance evaluation (as defined in § 63.2), you must submit the results of the performance evaluation following the procedures specified in paragraphs (g)(1) through (3) of this section.
(1) Performance evaluations of CEMS measuring relative accuracy test audit (RATA) pollutants that are supported by the EPA's ERT as listed on the EPA's ERT website at the time of the evaluation. Submit the results of the performance evaluation to the EPA via CEDRI, which can be accessed through the EPA's CDX. The data must be submitted in a file format generated using the EPA's ERT. Alternatively, you may submit an electronic file consistent with the XML schema listed on the EPA's ERT website.
(2) Performance evaluations of CEMS measuring RATA pollutants that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the evaluation. The results of the performance evaluation must be included as an attachment in the ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the ERT generated package or alternative file to the EPA via CEDRI.
(3) CBI. Do not use CEDRI to submit information you claim as CBI. Anything submitted using CEDRI cannot later be claimed CBI. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim for some of the information submitted under paragraph (g)(1)(i) or (ii) of this section, you must submit a complete file, including information claimed to be CBI, to the EPA. The CBI file must be generated using the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the CBI file on a compact disc, flash drive, or other commonly used electronic storage medium and clearly mark the medium as CBI. Mail the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described in paragraphs (g)(1)(i) and (ii) of this section. All CBI claims must be asserted at the time of submission. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available.
(h) Extensions for CDX/CEDRI outages. If you are required to electronically submit a report through CEDRI in the EPA's CDX, you may assert a claim of EPA system outage for failure to timely comply with that reporting requirement. To assert a claim of EPA system outage, you must meet the requirements outlined in paragraphs (h)(1) through (7) of this section.
(1) You must have been or will be precluded from accessing CEDRI and submitting a required report within the time prescribed due to an outage of either the EPA's CEDRI or CDX systems.
(2) The outage must have occurred within the period of time beginning five business days prior to the date that the submission is due.
(3) The outage may be planned or unplanned.
(4) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(5) You must provide to the Administrator a written description identifying:
(i) The date(s) and time(s) when CDX or CEDRI was accessed and the system was unavailable;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to EPA system outage;
(iii) A description of measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(6) The decision to accept the claim of EPA system outage and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(7) In any circumstance, the report must be submitted electronically as soon as possible after the outage is resolved.
(i) Extensions for force majeure events. If you are required to electronically submit a report through CEDRI in the EPA's CDX, you may assert a claim of force majeure for failure to timely comply with that reporting requirement. To assert a claim of force majeure, you must meet the requirements outlined in paragraphs (i)(1) through (5) of this section.
(1) You may submit a claim if a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature ( e.g., hurricanes, earthquakes, or floods), acts of war or terrorism, or equipment failure or safety hazard beyond the control of the affected facility ( e.g., large scale power outage).
(2) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(3) You must provide to the Administrator:
(i) A written description of the force majeure event;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to the force majeure event;
(iii) A description of measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(4) The decision to accept the claim of force majeure and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(5) In any circumstance, the reporting must occur as soon as possible after the force majeure event occurs.
§ 63.367   Recordkeeping requirements.
(a) If you own or operate an affected source subject to § 63.362, you must comply with the recordkeeping requirements in § 63.10(a) through (c), according to the applicability in table 6 to this subpart, and in this section. All records required to be maintained by this subpart or a subpart referenced by this subpart shall be maintained in such a manner that they can be readily accessed and are suitable for inspection.
(b) You must maintain the previous five years of records specified in § 63.366(b) and (c), as applicable.
(c) You must maintain the previous five years of records for compliance tests and associated data analysis, as applicable.
(d) Any records required to be maintained by this subpart that are submitted electronically via the EPA's CEDRI may be maintained in electronic format. This ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
(e) If you are using an EtO CEMS to demonstrate continuous compliance, you must maintain the previous five years of records for all required certification and QA tests.
(f) For each deviation from an emission limit, operating limit, or best management practice, you must keep a record of the information specified in paragraph (g)(1) through (4) of this section. The records shall be maintained as specified in § 63.10(b)(1).
(1) The occurrence and duration of each startup, shutdown, or malfunction of process, air pollution control, and monitoring equipment.
(2) In the event that an affected unit does not meet an applicable standard, record the number of deviations. For each deviation, record the date, time, cause, and duration of each deviation.
(3) For each failure to meet an applicable standard, record and retain a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit and a description of the method used to estimate the emissions.
(4) Record actions taken to minimize emissions in accordance with § 63.362(k) and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
§ 63.368   Implementation and enforcement.
(a) This subpart can be implemented and enforced by the U.S. EPA or a delegated authority such as the applicable State, local, or Tribal agency. If the U.S. EPA Administrator has delegated authority to a State, local, or Tribal agency, then that agency, in addition to the U.S. EPA, has the authority to implement and enforce this subpart. Contact the applicable U.S. EPA Regional Office to find out whether implementation and enforcement of this subpart are delegated to a State, local, or Tribal agency.
(b) In delegating implementation and enforcement authority of this subpart to a State, local, or Tribal agency under subpart E of this part, the authorities contained in paragraph (c) of this section are retained by the Administrator of U.S. EPA and cannot be transferred to the State, local, or Tribal agency.
(c) The authorities that cannot be delegated to State, local, or Tribal agencies are as specified in paragraphs (c)(1) through (5) of this section.
(1) Approval of alternatives to the requirements in §§ 63.360 and 63.362.
(2) Approval of major alternatives to test methods under § 63.7(e)(2)(ii) and (f), as defined in § 63.90, and as required in this subpart.
(3) Approval of major alternatives to monitoring under § 63.8(f), as defined in § 63.90, and as required in this subpart.
(4) Approval of major alternatives to recordkeeping and reporting under § 63.10(f), as defined in § 63.90, and as required in this subpart.
(5) Approval of an alternative to any electronic reporting to the EPA required by this subpart.
§ 63.400   Applicability.
(a) The provisions of this subpart apply to all new and existing industrial process cooling towers that are operated with chromium-based water treatment chemicals and are either major sources or are integral parts of facilities that are major sources as defined in § 63.401.
(b) Table 1 of this subpart specifies the provisions of subpart A that apply and those that do not apply to owners and operators of IPCT's subject to this subpart.
§ 63.401   Definitions.
Terms used in this subpart are defined in the Act, in subpart A of this part, or in this section as follows:
Chromium-based water treatment chemicals means any combination of chemical substances containing chromium used to treat water.
Commenced means, with respect to construction or reconstruction of an IPCT, that an owner or operator has undertaken a continuous program of construction or reconstruction or that an owner or operator has entered into a contractual obligation to undertake and complete, within a reasonable time, a continuous program of construction or reconstruction.
Compliance date means the date by which an affected IPCT is required to be in compliance with this subpart.
Construction means the on-site fabrication, erection, or installation of an IPCT.
Cooling tower means an open water recirculating device that uses fans or natural draft to draw or force ambient air through the device to cool warm water by direct contact.
Effective date means September 8, 1994, for this subpart.
Existing IPCT means any affected IPCT that is not a new IPCT.
Industrial process cooling tower, also written as “IPCT,” means any cooling tower that is used to remove heat that is produced as an input or output of a chemical or industrial process(es), as well as any cooling tower that cools industrial processes in combination with any heating, ventilation, or air conditioning system.
Initial startup means the initiation of recirculation water flow within the cooling tower.
Major source means any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit considering controls, in the aggregate, 10 tons per year or more of any hazardous air pollutant or 25 tons per year or more of any combination of hazardous air pollutants.
New IPCT means any affected IPCT the construction or reconstruction of which commenced after August 12, 1993.
Owner or operator means any person who owns, leases, operates, controls, or supervises an IPCT.
Potential to emit means the maximum capacity of a stationary source to emit a pollutant under its physical and operational design. Any physical or operational limitation on the capacity of the stationary source to emit a pollutant, including air pollution control equipment and restrictions on hours of operation or on the type or amount of material combusted, stored, or processed, shall be treated as part of its design if the limitation or the effect it would have on emissions is federally enforceable.
Reconstruction means the replacement of components of an affected or a previously unaffected IPCT to such an extent that the fixed capital cost of the new components exceeds 50 percent of the fixed capital cost that would be required to construct a comparable new IPCT.
Responsible official means one of the following:
(1) For a corporation: a president, secretary, treasurer, or vice president of the corporation in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the corporation, or a duly authorized representative of such person if the representative is responsible for the overall operation of one or more manufacturing, production, or operating facilities and either:
(i) The facilities employ more than 250 persons or have gross annual sales or expenditures exceeding $25 million (in second quarter 1980 dollars); or
(ii) The delegation of authority to such representative is approved in advance by the Administrator.
(2) For a partnership or sole proprietorship: a general partner or the proprietor, respectively.
(3) For a municipality, State, Federal, or other public agency: either a principal executive officer or ranking elected official. For the purposes of this part, a principal executive officer of a Federal agency includes the chief executive officer having responsibility for the overall operations of a principal geographic unit of the agency (e.g., a Regional Administrator of the EPA).
(4) For affected sources (as defined in this part) applying for or subject to a title V permit: “responsible official” shall have the same meaning as defined in part 70 of this chapter or Federal title V regulations (42 U.S.C. 7661), whichever is applicable.
Water treatment chemicals means any combination of chemical substances used to treat water in cooling towers, including corrosion inhibitors, antiscalants, dispersants, and any other chemical substances used to treat water.
§ 63.402   Standard.
No owner or operator of an IPCT shall use chromium-based water treatment chemicals in any affected IPCT.
§ 63.403   Compliance dates.
The requirements of § 63.402 of this subpart shall be applied on the following schedule:
(a) For existing IPCT's, the compliance date shall be 18 months after September 8, 1994.
(b) For new IPCT's that have an initial startup before September 8, 1994, the compliance date shall be September 8, 1994.
(c) For new IPCT's that have an initial startup on or after September 8, 1994, the compliance date shall be the date of the initial startup.
§ 63.404   Compliance demonstrations.
No routine monitoring, sampling, or analysis is required. In accordance with section 114 of the Act, the Administrator or delegated authority can require cooling water sample analysis of an IPCT if there is information to indicate that the IPCT is not in compliance with the requirements of § 63.402 of this subpart. The owner or operator of an IPCT may demonstrate compliance through recordkeeping in accordance with paragraph (c) of this section in lieu of a water sample analysis. If cooling water sample analysis is required:
(a) The water sample analysis shall be conducted in accordance with Method 7196, Chromium, Hexavalent (Colorimetric), contained in the Third Edition of “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods,” EPA Publication SW-846, (November 1986) and its Revision I, (December 1987), which are available for the cost of $110.00 from the Government Printing Office, Superintendent of Documents, Washington, DC 20402, (202) 783-3238 (document number 955-001-00000-1; or Method 3500-Cr D, Colorimetric Method, contained in the 18th Edition of “Standard Methods for the Examination of Water and Wastewaster” (1992), which is available from the American Public Health Association, 1015 15th Street, NW., Washington, DC 20005. These methods were approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be inspected as a part of Docket A-91-65, located at the Air and Radiation Docket and Information Center, room M1500, EPA Central Docket Section, 401 M St., SW., Washington, DC. Copies may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) On or after 3 months after the compliance date, a cooling water sample residual hexavalent chromium concentration equal to or less than 0.5 parts per million by weight shall indicate compliance with § 63.402. Alternatively, an owner or operator may demonstrate compliance through record keeping in accordance with paragraph (c).
(c) To demonstrate compliance with § 63.402, in lieu of the water sample analysis provided for in paragraph (a) of this section, the owner or operator of each IPCT may maintain records of water treatment chemical purchases, including invoices and other documentation that includes invoices and other documentation that includes date(s) of purchase or shipment, trade name or other information to identify composition of the product, and quantity of the product.
(d) Following a request, by the Administrator or delegated authority, under paragraph (a) for a water sample analysis, failure to either meet the concentration level specified in paragraph (b) or provide the records specified in paragraph (c) shall indicate a violation of § 63.402.
§ 63.405   Notification requirements.
(a) Initial notification. (1) In accordance with § 63.9(b) of subpart A, owners or operators of all affected IPCT's that have an initial startup before September 8, 1994, shall notify the Administrator in writing. The notification, which shall be submitted not later than 12 months after September 8, 1994, or no later than 120 days after the source becomes subject to this subpart, whichever is later, shall provide the following information:
(i) The name and address of the IPCT owner or operator;
(ii) The address (i.e., physical location) of the affected IPCT;
(iii) A statement that the notification is being submitted as required by this subpart; and
(iv) A description of the type of water treatment program used in the affected IPCT, including the chemical name of each corrosion inhibitor ingredient used; the average concentration of those corrosion inhibitor ingredients maintained in the cooling water; and the material safety data sheet for each water treatment chemical or chemical compound used in the IPCT.
(2) In accordance with § 63.9(b) of subpart A, owners or operators of all affected IPCT's that have an initial startup on or after September 8, 1994, shall notify the Administrator in writing that the source is subject to the relevant standard no later than 12 months after initial startup or no later than 120 days after the source becomes subject to this subpart, whichever is later. The notification shall provide all the information required in paragraphs (a)(1)(i) through (iv) of this section.
(b) Notification of compliance status. (1) In accordance with § 63.9(h) of subpart A, owners or operators of affected IPCT's shall submit to the Administrator a notification of compliance status within 60 days of the date on which the IPCT is brought into compliance with § 63.402 of this subpart and not later than 18 months after September 8, 1994, or no later than 120 days after the source becomes subject to this subpart, whichever is later.
(2) The notification of compliance status must:
(i) Be signed by a responsible official who also certifies the accuracy of the report;
(ii) Certify that source has complied with § 63.402 of this subpart; and
(iii) Include the information required in paragraph (a)(1)(iv) of this section.
(iv) Include the following statement:
I certify that no chromium-based water treatment chemicals have been introduced since (the initial compliance date) into any IPCT located within the facility for any purpose.
§ 63.406   Recordkeeping and reporting requirements.
To demonstrate continuing compliance with § 63.402 of this subpart, the owner or operator of each affected IPCT shall maintain copies of the initial notification and the notification of compliance status as required by § 63.405 of this subpart for a period of at least 5 years onsite.
§ 63.407   Implementation and enforcement.
(a) This subpart can be implemented and enforced by the U.S. EPA, or a delegated authority such as the applicable State, local, or Tribal agency. If the U.S. EPA Administrator has delegated authority to a State, local, or Tribal agency, then that agency, in addition to the U.S. EPA, has the authority to implement and enforce this subpart. Contact the applicable U.S. EPA Regional Office to find out if implementation and enforcement of this subpart is delegated to a State, local, or Tribal agency.
(b) In delegating implementation and enforcement authority of this subpart to a State, local, or Tribal agency under subpart E of this part, the authorities contained in paragraph (c) of this section are retained by the Administrator of U.S. EPA and cannot be transferred to the State, local, or Tribal agency.
(c) The authorities that cannot be delegated to State, local, or Tribal agencies are as specified in paragraphs (c)(1) through (4) of this section.
(1) Approval of alternatives to the requirements in §§ 63.400 and 63.402 through 63.403.
(2) Approval of major alternatives to test methods under § 63.7(e)(2)(ii) and (f), as defined in § 63.90, and as required in this subpart.
(3) Approval of major alternatives to monitoring under § 63.8(f), as defined in § 63.90, and as required in this subpart.
(4) Approval of major alternatives to recordkeeping and reporting under § 63.10(f), as defined in § 63.90, and as required in this subpart.
§ 63.420   Applicability.
(a) Prior to May 8, 2027, the affected source to which the provisions of this subpart apply is each bulk gasoline terminal, except those bulk gasoline terminals meeting either of the criteria listed in paragraph (a)(1) or (2) of this section. No later than May 8, 2027, the affected source to which the provisions of this subpart apply is each bulk gasoline terminal located at a major source as defined in § 63.2.
(1) Bulk gasoline terminals for which the owner or operator has documented and recorded to the Administrator's satisfaction that the result, E T , of the following equation is less than 1, and complies with requirements in paragraphs (c), (d), (e), and (f) of this section:
(2) Bulk gasoline terminals for which the owner or operator has documented and recorded to the Administrator's satisfaction that the facility is not a major source, or is not located within a contiguous area and under common control of a facility that is a major source, as defined in § 63.2.
(b) Prior to May 8, 2027, the affected source to which the provisions of this subpart apply is each pipeline breakout station, except those pipeline breakout stations meeting either of the criteria listed in paragraph (b)(1) or (2) of this section. No later than May 8, 2027, the affected source to which the provisions of this subpart apply is each pipeline breakout station located at a major source as defined in § 63.2.
(1) Pipeline breakout stations for which the owner or operator has documented and recorded to the Administrator's satisfaction that the result, E P , of the following equation is less than 1, and complies with requirements in paragraphs (c), (d), (e), and (f) of this section:
(2) Pipeline breakout stations for which the owner or operator has documented and recorded to the Administrator's satisfaction that the facility is not a major source, or is not located within a contiguous area and under common control of a facility that is a major source, as defined in § 63.2.
(c) Prior to May 8, 2027, a facility for which the results, E T or E P , of the calculation in paragraph (a)(1) or (b)(1) of this section has been documented and is less than 1.0 but greater than or equal to 0.50, is exempt from the requirements of this subpart, except that the owner or operator shall:
(1) Operate the facility such that none of the facility parameters used to calculate results under paragraph (a)(1) or (b)(1) of this section, and approved by the Administrator, is exceeded in any rolling 30-day period; and
(2) Maintain records and provide reports in accordance with the provisions of § 63.428(l)(4).
(d) Prior to May 8, 2027, a facility for which the results, E T or E P , of the calculation in paragraph (a)(1) or (b)(1) of this section has been documented and is less than 0.50, is exempt from the requirements of this subpart, except that the owner or operator shall:
(1) Operate the facility such that none of the facility parameters used to calculate results under paragraph (a)(1) or (b)(1) of this section is exceeded in any rolling 30-day period; and
(2) Maintain records and provide reports in accordance with the provisions of § 63.428(l)(5).
(e) The provisions of paragraphs (a)(1) and (b)(1) of this section shall not be used to determine applicability to bulk gasoline terminals or pipeline breakout stations that are either:
(1) Located within a contiguous area and under common control with another bulk gasoline terminal or pipeline breakout station, or
(2) Located within a contiguous area and under common control with other sources not specified in paragraphs (a)(1) or (b)(1) of this section, that emit or have the potential to emit a hazardous air pollutant.
(f) Upon request by the Administrator, the owner or operator of a bulk gasoline terminal or pipeline breakout station subject to the provisions of any paragraphs in this section including, but not limited to, the parameters and assumptions used in the applicable equation in paragraph (a)(1) or (b)(1) of this section, shall demonstrate compliance with those paragraphs.
(g) Each owner or operator of a bulk gasoline terminal or pipeline breakout station subject to the provisions of this subpart that is also subject to applicable provisions of part 60, subpart Kb, XX, or XXa, of this chapter shall comply only with the provisions in each subpart that contain the most stringent control requirements for that facility.
(h) Each owner or operator of an affected source bulk gasoline terminal or pipeline breakout station is subject to the provisions of 40 CFR part 63, subpart A—General Provisions, as indicated in Table 1.
(i) A bulk gasoline terminal or pipeline breakout station with a Standard Industrial Classification code 2911 located within a contiguous area and under common control with a refinery complying with §§ 63.646, 63.648, 63.649, 63.650, and 63.660 is not subject to the standards in this subpart, except as specified in § 63.650.
(j) Notwithstanding any other provision of this subpart, the December 14, 1995, compliance date for existing facilities in §§ 63.424(e) and 63.428(a), (l)(4)(i), and (l)(5)(i) is stayed from December 8, 1995, to March 7, 1996.
(k) Each owner or operator of an affected source bulk gasoline terminal or pipeline breakout station must comply with the standards in this part at all times. At all times, the owner or operator must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.