(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.

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.

(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.

Where: CESCombined = The combined emission stream limit based upon monitoring after the emission streams are combined, in pounds. M30day = The 30-operating day total mass sent to controls for the combined emission stream (i.e., monitoring data at the inlet of the control system), as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “M30day” as used in this equation is equivalent to the term “E30day” as designated in equation A-3. Max(ER) = The most stringent emission reduction standard specified in tables 1 through 5 of this subpart applicable to any of the constituent streams, in decimal format.

(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 ECombined. 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 ECombined.

(iii) Compliance with the combined emission streams limitation shall be determined by demonstrating that ECombined, as calculated in accordance with paragraph (i)(1)(ii) of this section, for each 30-operating day period is at or below CESCombined, 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.

Where: CESStreams = The combined emission stream limit based upon monitoring before the emission streams are combined, in pounds. Mc,i = The 30-operating day total mass sent to controls for each non-SCV constituent emission stream (i.e., monitoring data at the inlet of the control system), as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “Mc,i” as used in this equation is equivalent to the term “E30day” as designated in equation A-3. ERi = The applicable emission reduction standard from tables 2 through 5 of this subpart to each non-SCV constituent emission stream i. i = Non-SCV constituent emission stream index. n = Total number of non-SCV constituent emission streams. Mc,j = The 30-operating day total mass sent to controls for each SCV emission stream, as determined in accordance with equation 10 of § 63.364(f)(1)(i)(C)(1). ERj = The applicable SCV emission reduction standard in table 1 to this subpart, in decimal format. j = SCV emission stream index. m = Total number of SCV emission streams.

(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 ECombined. 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 ECombined.

(iii) Compliance with the combined emission streams limitation shall be determined by demonstrating that ECombined, as calculated in accordance with paragraph (i)(2)(ii) of this section, for each 30-operating day period is at or below CESStreams, 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.

Where: SWELFac = SWEL based upon facility EtO use, in pounds. MFac = Facility EtO use over the previous 30 operating days, in pounds, as determined in accordance with equation 11 of § 63.364(i)(2). 0.99 = Adjustment factor for EtO residual in sterilized product. ERSCV = The applicable SCV emission reduction standard in table 1 to this subpart, in decimal format.

(ii) The 30-operating day rolling sum of emissions are determined daily using equation 4 to this paragraph.

Where: EFac = The total emissions from the facility over the previous 30-operating days, in pounds. Eo,i = The 30-operating day rolling sum of emissions calculated at each exhaust stack, i, monitored by an EtO CEMS, as calculated using equation A-3 of appendix A to this subpart. i = Exhaust stack index n = Total number of exhaust stacks

(iii) Compliance with the SWEL based upon facility EtO usage shall be determined by demonstrating that EFac, 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.

Where: SWELStreams = SWEL based upon individual emissions streams, in pounds. Mc,i = The 30-operating day total mass sent to controls (i.e., monitoring data at the inlet of the control system) for each non-SCV emission stream, as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “Mc,i” as used in this equation is equivalent to the term “E30day” as designated in equation A-3. ERi = The applicable emission reduction standard to each non-SCV emission stream, i, specified in tables 1 through 5 of this subpart, in decimal format. i = Non-SCV emission streams index. n = Total number of non-SCV emission streams. Mc,j = The 30-operating day total mass sent to controls for each SCV emission stream, as determined in accordance with equation 10 in § 63.364(f)(1)(i)(C)(1). ERj = The applicable SCV emission reduction standard in table 1 to this subpart, in decimal format. j = SCV emission stream index. m = Total number of SCV emission streams.

(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 EFac, as calculated in accordance with paragraph (j)(2)(ii) of this section, for each 30-operating day period is at or below SWELStreams, 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.

(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).

(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 (MSCV,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 (Mc) vented to the controls using equation 1 to this paragraph.

Where: MSCV,n = Theoretical total mass of EtO vented to controls per charge, g (lb) Mcharge = total mass of sterilizer gas charge, g (lb) %EOw = weight percent of EtO

(2) Install a calibrated rate meter at the sterilizer inlet(s) and continuously measure the flow rate (Qm) and duration of each sterilizer charge. Calculate the theoretical mass (MSCV,n) vented to the controls using equation 2 to this paragraph.

Where: MSCV,n = theoretical total mass of EtO sent to controls per charge Qm = volumetric flow rate, liters per minute (L/min) corrected to 20 °C and 101.325 kilopascals (kPa) (scf per minute (scfm) corrected to 68 °F and 1 atmosphere of pressure (atm)) Tn = time duration of each charge, min %EOv = volume fraction percent of EtO n = number of EtO charges MW = molecular weight of EtO, 44.05 grams per gram-mole (g/g-mole) (44.05 pounds per pound-mole (lb/lb-mole)) SV = standard volume, 24.05 liters per gram-mole (L/g-mole) at 20 °C and 101.325 kPa (385.1 scf per pound-mole (scf/lb-mole) at 68 °F and 1 atm).

(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.

Where: f = Adjustment factor. I = Mass of non-SCV EtO routed to control devices over the previous 30 operating days MFac = Facility EtO use over the previous 30-operating days, in pounds, as determined in accordance with equation 11 of § 63.364(i)(2) Where: I = Mass of non-SCV EtO routed to control devices over the previous 30 operating days Mc,i = The 30-operating day total mass sent to controls (i.e., monitoring data at the inlet of the control system) for each non-SCV emission stream, as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “Mc,i” as used in this equation is equivalent to the term “E30day” as designated in equation A-3. i = Non-SCV emission stream index. n = Total number of non-SCV emission streams.

(C)(1) Determine the mass rate of EtO sent to controls during the previous 30 days using equation 5 to this paragraph.

Where: MSCV = Total mass of EtO sent to controls over the previous 30 operating days, g/hr (lb/hr) f = Adjustment factor MSCV,n = Theoretical mass of EtO sent to controls per charge per chamber, g (lb) n = Total number of charges during the previous 30 operating days

(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.

Where: MFac = Facility EtO use over the previous 30 operating days, in pounds. mFac,i = Daily EtO use for operating day i, in pounds, as determined in accordance with paragraph (i)(1) of this section i = Operating day index.

(3) Determine and record the total mass of EtO used in each calendar month.

(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 (MAPCD, i) and/or outlet of a control system or stack (EAPCD, 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:

Where: MAPCD, i = average inlet mass rate of EtO per hour, lb/hr CEtO,i = inlet EtO concentration, ppmdv. Qi = average inlet volumetric flow per hour at standard conditions, dscf/hr 44.05 = molecular weight (MW) of EtO, lb/lb-mole MW/385.1 × 10 6 = conversion factor, from ppmv at standard conditions to lb/cf EAPCD, o = average outlet mass rate of EtO per hour, lb/hr CEtO,o = outlet EtO concentration, ppbdv. Qo = average outlet volumetric flow per hour at standard conditions, dscf/hr MW/385.1 × 10 9 = conversion factor, from ppbv at standard conditions to lb/cf

(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 (MSCV,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 (MSCV,n) vented to the controls using equation 4 to this paragraph.

Where: MSCV,n = Theoretical total mass of EtO vented to controls per charge, g (lb) Mcharge = total mass of sterilizer gas charge, g (lb) %E.O.w = weight percent of EtO

(ii) Install a calibrated rate meter at the sterilizer inlet(s) and continuously measure the flow rate (Qm) and duration of each sterilizer charge. Calculate the theoretical mass (MSCV,n) vented to the controls using equation 5 to this paragraph.

Where: MSCV,n = Total mass of EtO sent to controls per charge Qm = volumetric flow rate, liters per minute (L/min) corrected to 20 °C and 101.325 kilopascals (kPa) (scf per minute (scfm) corrected to 68 °F and 1 atmosphere of pressure (atm)) Tn = time duration of each charge, min n = number of EtO charges %E.O.v = volume fraction percent of EtO MW = molecular weight of EtO, 44.05 grams per gram-mole (g/g-mole) (44.05 pounds per pound-mole (lb/lb-mole)) SV = standard volume, 24.05 liters per gram-mole (L/g-mole) at 20 °C and 101.325 kPa (385.1 scf per pound-mole (scf/lb-mole) at 68 °F and 1 atm).

(2) Determine the mass rate of EtO sent to controls during the performance test using equation 6 to this paragraph.

Where: MSCV = Total mass of EtO sent to controls per hour, g/hr (lb/hr) MSCV,n = Total mass of EtO sent to controls per charge per chamber, g (lb) Tt = Total time of the performance test, hour n = Total number of charges during testing period f = Portion of EtO use that is assumed to be routed to the control system (0.93 if aeration is conducted in separate vessel; 0.98 otherwise)

(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:

Where: % ER = percent emission reduction MAPCD,i = total mass of EtO per hour to the control device EAPCD,o = total mass of EtO per hour from the control device

(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.

(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.

(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.

(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.

As required in § 63.362(c), for each SCV, you must meet the applicable standard in the following table:

As required in § 63.362(d), for each ARV, you must meet the applicable standard in the following table:

As required in § 63.362(e), for each CEV, you must meet the applicable standard in the following table:

As required in § 63.362(f), for your collection of Group 1 room air emissions at each facility, you must meet the applicable standard in the following table:

As required in § 63.362(g), for your collection of Group 2 room air emissions, you must meet the applicable standard in the following table:

As specified in § 63.360, the parts of the General Provisions that apply to you are shown in the following table:

1. Applicability

These monitoring provisions apply to the measurement of EtO emissions from commercial sterilization facilities, using CEMS. The CEMS must be capable of measuring EtO in lb/hr.

2. Monitoring of EtO Emissions

2.1 Monitoring System Installation Requirements. Install EtO CEMS and any additional monitoring systems needed to convert pollutant concentrations to lb/hr in accordance with § 63.365 and Performance Specification 19 (PS 19) of appendix B to part 60 of this chapter.

2.2 Primary and Backup Monitoring Systems. In the electronic monitoring plan described in section 10.1.1.2.1 of this appendix, you must designate a primary EtO CEMS. The primary EtO CEMS must be used to report hourly EtO concentration values when the system is able to provide quality-assured data, i.e., when the system is “in control”. However, to increase data availability in the event of a primary monitoring system outage, you may install, operate, maintain, and calibrate backup monitoring systems, as follows:

2.2.1 Redundant Backup Systems. A redundant backup monitoring system is a separate EtO CEMS with its own probe, sample interface, and analyzer. A redundant backup system is one that is permanently installed at the unit or stack location and is kept on “hot standby” in case the primary monitoring system is unable to provide quality-assured data. A redundant backup system must be represented as a unique monitoring system in the electronic monitoring plan. Each redundant backup monitoring system must be certified according to the applicable provisions in section 3 of this appendix and must meet the applicable on-going QA requirements in section 5 of this appendix.

2.2.2 Non-redundant Backup Monitoring Systems. A non-redundant backup monitoring system is a separate EtO CEMS that has been certified at a particular unit or stack location but is not permanently installed at that location. Rather, the system is kept on “cold standby” and may be reinstalled in the event of a primary monitoring system outage. A nonredundant backup monitoring system must be represented as a unique monitoring system in the electronic monitoring plan. Non-redundant backup EtO CEMS must complete the same certification tests as the primary monitoring system, with one exception. The 7-day calibration error test is not required for a non-redundant backup EtO CEMS. Except as otherwise provided in section 2.2.4.4 of this appendix, a non-redundant backup monitoring system may only be used for 720 hours per year at a particular unit or stack location.

2.2.3 Temporary Like-kind Replacement Analyzers. When a primary EtO analyzer needs repair or maintenance, you may temporarily install a like-kind replacement analyzer, to minimize data loss. Except as otherwise provided in section 2.2.4.4 of this appendix, a temporary like-kind replacement analyzer may only be used for 720 hours per year at a particular unit or stack location. The analyzer must be represented as a component of the primary EtO CEMS and must be assigned a 3-character component ID number, beginning with the prefix “LK”.

2.2.4 Quality Assurance Requirements for Non-redundant Backup Monitoring Systems and Temporary Like-kind Replacement Analyzers. To quality-assure the data from non-redundant backup EtO monitoring systems and temporary like-kind replacement EtO analyzers, the following provisions apply:

2.2.4.1 When a certified non-redundant backup EtO CEMS or a temporary like-kind replacement EtO analyzer is brought into service, a calibration error test and a linearity check must be performed and passed. A single point system integrity check is also required.

2.2.4.2 Each non-redundant backup EtO CEMS or temporary like-kind replacement EtO analyzer shall comply with all required daily, weekly, and quarterly quality-assurance test requirements in section 5 of this appendix, for as long as the system or analyzer remains in service.

2.2.4.3 For the routine, on-going quality-assurance of a non-redundant backup EtO monitoring system, a relative accuracy test audit (RATA) must be performed and passed at least once every 8 calendar quarters at the unit or stack location(s) where the system will be used.

2.2.4.4 To use a non-redundant backup EtO monitoring system or a temporary like-kind replacement analyzer for more than 720 hours per year at a particular unit or stack location, a RATA must first be performed and passed at that location.

2.3 Monitoring System Equipment, Supplies, Definitions, and General Operation.

The following provisions apply:

2.3.1 PS 19, Sections 3.0, 6.0, and 11.0 of appendix B to part 60 of this chapter.

3. Initial Certification Procedures

The initial certification procedures for the EtO CEMS used to provide data under this subpart are as follows:

3.1 Your EtO CEMS must be certified according to PS 19, section(s) 13.

3.2 Any additional stack gas flow rate monitoring system(s) needed to express pollutant concentrations in lb/hr must be certified according to part 75 of this chapter.

4. Recertification Procedures

Whenever the owner or operator makes a replacement, modification, or change to a certified CEMS that may significantly affect the ability of the system to accurately measure or record pollutant gas concentrations or stack gas flow rates, the owner or operator shall recertify the monitoring system. Furthermore, whenever the owner or operator makes a replacement, modification, or change to the flue gas handling system or the unit operation that may significantly change the concentration or flow profile, the owner or operator shall recertify the monitoring system. The same tests performed for the initial certification of the monitoring system shall be repeated for recertification, unless otherwise specified by the Administrator. Examples of changes that require recertification include: Replacement of a gas analyzer; complete monitoring system replacement, and changing the location or orientation of the sampling probe.

5. On-Going Quality Assurance Requirements

On-going QA test requirements for EtO CEMS must be implemented as follows:

5.1 The quality assurance/quality control procedures in Procedure 7 of appendix F to part 60 of this chapter shall apply.

5.2 Stack gas flow rate, diluent gas, and moisture monitoring systems must meet the applicable ongoing QA test requirements of part 75 of this chapter.

5.2.1 Out-of-Control Periods. A EtO CEMS that is used to provide data under this appendix is considered to be out-of-control, and data from the CEMS may not be reported as quality-assured, when any acceptance criteria for a required QA test is not met. The EtO CEMS is also considered to be out-of-control when a required QA test is not performed on schedule or within an allotted grace period. To end an out-of-control period, the QA test that was either failed or not done on time must be performed and passed. Out-of-control periods are counted as hours of monitoring system downtime.

5.2.2 Grace Periods. For the purposes of this appendix, a “grace period” is defined as a specified number of unit or stack operating hours after the deadline for a required quality-assurance test of a continuous monitor has passed, in which the test may be performed and passed without loss of data.

5.2.2.1 For the flow rate monitoring systems described in section 5.1 of this appendix, a 168 unit or stack operating hour grace period is available for quarterly linearity checks, and a 720 unit or stack operating hour grace period is available for RATAs, as provided, respectively, in sections 2.2.4 and 2.3.3 of appendix B to part 75 of this chapter.

5.2.2.2 For the purposes of this appendix, if the deadline for a required gas audit or RATA of a EtO CEMS cannot be met due to circumstances beyond the control of the owner or operator:

5.2.2.2.1 A 168 unit or stack operating hour grace period is available in which to perform the gas audit; or

5.2.2.2.2 A 720 unit or stack operating hour grace period is available in which to perform the RATA.

5.2.2.3 If a required QA test is performed during a grace period, the deadline for the next test shall be determined as follows:

5.2.2.3.1 For the gas audit of an EtO CEMS, the grace period test only satisfies the audit requirement for the calendar quarter in which the test was originally due. If the calendar quarter in which the grace period audit is performed is a QA operating quarter, an additional gas audit is required for that quarter.

5.2.2.3.2 For the RATA of an EtO CEMS, the next RATA is due within three QA operating quarters after the calendar quarter in which the grace period test is performed.

5.2.3 Conditional Data Validation. For recertification and diagnostic testing of the monitoring systems that are used to provide data under this appendix, and for the required QA tests when nonredundant backup monitoring systems or temporary like-kind replacement analyzers are brought into service, the conditional data validation provisions in §§ 75.20(b)(3)(ii) through (b)(3)(ix) of this chapter may be used to avoid or minimize data loss. The allotted window of time to complete calibration tests and RATAs shall be as specified in § 75.20(b)(3)(iv) of this chapter; the allotted window of time to complete a gas audit shall be the same as for a linearity check (i.e., 168 unit or stack operating hours).

5.3 Data Validation.

5.3.1 Out-of-Control Periods. An EtO CEMS that is used to provide data under this appendix is considered to be out-of-control, and data from the CEMS may not be reported as quality-assured, when any acceptance criteria for a required QA test is not met. The EtO CEMS is also considered to be out-of-control when a required QA test is not performed on schedule or within an allotted grace period. To end an out-of-control period, the QA test that was either failed or not done on time must be performed and passed. Out-of-control periods are counted as hours of monitoring system downtime.

5.3.2 Grace Periods. For the purposes of this appendix, a “grace period” is defined as a specified number of unit or stack operating hours after the deadline for a required quality-assurance test of a continuous monitor has passed, in which the test may be performed and passed without loss of data.

5.3.2.1 For the monitoring systems described in section 5.1 of this appendix, a 168 unit or stack operating hour grace period is available for quarterly linearity checks, and a 720 unit or stack operating hour grace period is available for RATAs, as provided, respectively, in sections 2.2.4 and 2.3.3 of appendix B to part 75 of this chapter.

5.3.2.2 For the purposes of this appendix, if the deadline for a required gas audit/data accuracy assessment or RATA of an EtO CEMS cannot be met due to circumstances beyond the control of the owner or operator:

5.3.2.2.1 A 168 unit or stack operating hour grace period is available in which to perform the gas audit or other quarterly data accuracy assessment; or

5.3.2.2.2 A 720 unit or stack operating hour grace period is available in which to perform the RATA.

5.3.2.3 If a required QA test is performed during a grace period, the deadline for the next test shall be determined as follows:

5.3.2.3.1 For a gas audit or RATA of the monitoring systems described in sections 5.1 and 5.2 of this appendix, determine the deadline for the next gas audit or RATA (as applicable) in accordance with section 2.2.4(b) or 2.3.3(d) of appendix B to part 75 of this chapter; treat a gas audit in the same manner as a linearity check.

5.3.2.3.2 For the gas audit or other quarterly data accuracy assessment of an EtO CEMS, the grace period test only satisfies the audit requirement for the calendar quarter in which the test was originally due. If the calendar quarter in which the grace period audit is performed is a QA operating quarter, an additional gas audit/data accuracy assessment is required for that quarter.

5.3.2.3.3 For the RATA of an EtO CEMS, the next RATA is due within three QA operating quarters after the calendar quarter in which the grace period test is performed.

5.3.3 Conditional Data Validation. For recertification and diagnostic testing of the monitoring systems that are used to provide data under this appendix, the conditional data validation provisions in § 75.20(b)(3)(ii) through (ix) of this chapter may be used to avoid or minimize data loss. The allotted window of time to complete calibration tests and RATAs shall be as specified in § 75.20(b)(3)(iv) of this chapter; the allotted window of time to complete a quarterly gas audit or data accuracy assessment shall be the same as for a linearity check (i.e., 168 unit or stack operating hours).

6. Missing Data Requirements

For the purposes of this appendix, the owner or operator of an affected unit shall not substitute for missing data from EtO CEMS. Any process operating hour for which quality-assured EtO concentration data are not obtained is counted as an hour of monitoring system downtime.

7. Bias Adjustment

Bias adjustment of hourly emissions data from an EtO CEMS is not required.

8. QA/QC Program Requirements

The owner or operator shall develop and implement a quality assurance/quality control (QA/QC) program for the EtO CEMS that are used to provide data under this subpart. At a minimum, the program shall include a written plan that describes in detail (or that refers to separate documents containing) complete, step-by-step procedures and operations for the most important QA/QC activities. Electronic storage of the QA/QC plan is permissible, provided that the information can be made available in hard copy to auditors and inspectors. The QA/QC program requirements for the other monitoring systems described in section 5.2 of this appendix are specified in section 1 of appendix B to part 75 of this chapter.

8.1 General Requirements for EtO CEMS.

8.1.1 Preventive Maintenance. Keep a written record of procedures needed to maintain the EtO CEMS in proper operating condition and a schedule for those procedures. This shall, at a minimum, include procedures specified by the manufacturers of the equipment and, if applicable, additional or alternate procedures developed for the equipment.

8.1.2 Recordkeeping and Reporting. Keep a written record describing procedures that will be used to implement the recordkeeping and reporting requirements of this appendix.

8.1.3 Maintenance Records. Keep a record of all testing, maintenance, or repair activities performed on any EtO CEMS in a location and format suitable for inspection. A maintenance log may be used for this purpose. The following records should be maintained: Date, time, and description of any testing, adjustment, repair, replacement, or preventive maintenance action performed on any monitoring system and records of any corrective actions associated with a monitor outage period. Additionally, any adjustment that may significantly affect a system's ability to accurately measure emissions data must be recorded and a written explanation of the procedures used to make the adjustment(s) shall be kept.

8.2 Specific Requirements for EtO CEMS. The following requirements are specific to EtO CEMS:

8.2.1 Keep a written record of the procedures used for each type of QA test required for each EtO CEMS. Explain how the results of each type of QA test are calculated and evaluated.

8.2.2 Explain how each component of the EtO CEMS will be adjusted to provide correct responses to calibration gases after routine maintenance, repairs, or corrective actions.

9. Data Reduction and Calculations

9.1 Design and operate the EtO CEMS to complete a minimum of one cycle of operation (sampling, analyzing, and data recording) for each successive 15-minute period.

9.2 Reduce the EtO concentration data to hourly averages in accordance with § 60.13(h)(2) of this chapter.

9.3 Convert each hourly average EtO concentration to an EtO mass emission rate (lb/hr) using an equation that has the general form of equation A-1 of this appendix:

Where: Eho = EtO mass emission rate for the hour, lb/hr K = Units conversion constant, 1.144E-10 lb/scf-ppbv, Ch = Hourly average EtO concentration, ppbv, Qh = Stack gas volumetric flow rate for the hour, scfh.

(Note: Use unadjusted flow rate values; bias adjustment is not required.)

9.4 Use equation A-2 of this appendix to calculate the daily total EtO emissions. Report each daily total to the same precision as the most stringent standard that applies to any affected source exhausting to the emission stream (e.g., if the emission stream includes contributions from an SCV and ARV subject to 99.99% and 99.9% emission reduction standards, respectively, report to four significant figures), expressed in scientific notation.

Where:

Eday = Total daily EtO emissions, lb.

Eho = Hourly EtO emission rate for unit or stack sampling hour “h” in the averaging period, from equation A-1 of this appendix, lb/hr.

9.5 Use equation A-3 of this appendix to calculate the 30-operating day rolling total EtO emissions. Report each 30-operating day rolling total to the same precision as the most stringent standard that applies to any affected source exhausting to the emission stream (e.g., if the emission stream includes contributions from an SCV and ARV subject to 99.99% and 99.9% emission reduction standards, respectively, report to four significant figures), expressed in scientific notation.

Where:

E30day = Total EtO emissions during the 30-operating day, lb.

Eday,i = Total daily EtO emissions, in lbs, for each operating day i from equation A-2 of this appendix, lb.

i = Operating day index.

10. Recordkeeping Requirements

10.1 For each EtO CEMS installed at an affected source, and for any other monitoring system(s) needed to convert pollutant concentrations to units of the applicable emissions limit, the owner or operator must maintain a file of all measurements, data, reports, and other information required by this appendix in a form suitable for inspection, for 5 years from the date of each record, in accordance with § 63.367. The file shall contain the information in paragraphs 10.1.1 through 10.1.8 of this section.

10.1.1 Monitoring Plan Records. For each affected source or group of sources monitored at a common stack, the owner or operator shall prepare and maintain a monitoring plan for the EtO CEMS and any other monitoring system(s) (i.e., flow rate, diluent gas, or moisture systems) needed to convert pollutant concentrations to units of the applicable emission standard. The monitoring plan shall contain essential information on the continuous monitoring systems and shall explain how the data derived from these systems ensure that all EtO emissions from the unit or stack are monitored and reported.

10.1.1.1 Updates. Whenever the owner or operator makes a replacement, modification, or change in a certified continuous EtO monitoring system that is used to provide data under this subpart (including a change in the automated data acquisition and handling system or the flue gas handling system) which affects information reported in the monitoring plan (e.g., a change to a serial number for a component of a monitoring system), the owner or operator shall update the monitoring plan.

10.1.1.2 Contents of the Monitoring Plan. For EtO CEMS, the monitoring plan shall contain the applicable electronic and hard copy information in sections 10.1.1.2.1 and 10.1.1.2.2 of this appendix. For stack gas flow rate, diluent gas, and moisture monitoring systems, the monitoring plan shall include the electronic and hard copy information required for those systems under § 75.53(g) of this chapter. The electronic monitoring plan shall be evaluated using CEDRI.

10.1.1.2.1 Electronic. Record the unit or stack ID number(s); monitoring location(s); the EtO monitoring methodology used (i.e., CEMS); EtO monitoring system information, including, but not limited to: unique system and component ID numbers; the make, model, and serial number of the monitoring equipment; the sample acquisition method; formulas used to calculate emissions; monitor span and range information (if applicable).

10.1.1.2.2 Hard Copy. Keep records of the following: schematics and/or blueprints showing the location of the monitoring system(s) and test ports; data flow diagrams; test protocols; monitor span and range calculations (if applicable); miscellaneous technical justifications.

10.1.2 EtO Emissions Records. For EtO CEMS, the owner or operator must record the following information for each unit or stack operating hour:

10.1.2.1 The date and hour;

10.1.2.2 Monitoring system and component identification codes, as provided in the electronic monitoring plan, for each hour in which the CEMS provides a quality-assured value of EtO concentration (as applicable);

10.1.2.3 The pollutant concentration, for each hour in which a quality-assured value is obtained. Record the data in parts per billion by volume (ppbv), with one leading non-zero digit and one decimal place, expressed in scientific notation. Use the following rounding convention: If the digit immediately following the first decimal place is 5 or greater, round the first decimal place upward (increase it by one); if the digit immediately following the first decimal place is 4 or less, leave the first decimal place unchanged.

10.1.2.4 A special code, indicating whether or not a quality-assured EtO concentration value is obtained for the hour. This code may be entered manually when a temporary like-kind replacement EtO analyzer is used for reporting; and

10.1.2.5 Monitor data availability, as a percentage of unit or stack operating hours, calculated according to § 75.32 of this chapter.

10.1.3 Stack Gas Volumetric Flow Rate Records.

10.1.3.1 Hourly measurements of stack gas volumetric flow rate during unit operation are required to demonstrate compliance with EtO emission standards.

10.1.3.2 Use a flow rate monitor that meets the requirements of part 75 of this chapter to record the required data. You must keep hourly flow rate records, as specified in § 75.57(c)(2) of this chapter.

10.1.4 EtO Emission Rate Records. Record the following information for each affected unit or common stack:

10.1.4.1 The date and hour;

10.1.4.2 The hourly EtO emissions rate (lb/hr), for each hour in which valid values of EtO concentration and stack gas volumetric flow rate are obtained for the hour. Report each emission rate to the same precision as the most stringent standard that applies to any affected source exhausting to the emission stream (e.g., if the emission stream includes contributions from an SCV and ARV subject to 99.99% and 99.9% emission reduction standards, respectively, report to four significant figures), expressed in scientific notation. Use the following rounding convention: If the digit immediately following the first decimal place is 5 or greater, round the first decimal place upward (increase it by one); if the digit immediately following the first decimal place is 4 or less, leave the first decimal place unchanged;

10.1.4.4 A code indicating that the EtO emission rate was not calculated for the hour, if valid data for EtO concentration and/or any of the other necessary parameters are not obtained for the hour. For the purposes of this appendix, the substitute data values required under part 75 of this chapter for stack gas flow rate are not considered to be valid data.

10.1.5 Certification and Quality Assurance Test Records. For the EtO CEMS used to provide data under this subpart at each affected unit (or group of units monitored at a common stack), record the following information for all required certification, recertification, diagnostic, and quality-assurance tests:

10.1.5.1 EtO CEMS.

10.1.5.1.1 For each required 7-day and daily calibration drift (CD) test or daily calibration error test (including daily calibration transfer standard tests) of the EtO CEMS, record the test date(s) and time(s), reference gas value(s), monitor response(s), and calculated calibration drift or calibration error value(s). If you use the dynamic spiking option for the mid-level calibration drift check under PS 19, you must also record the measured concentration of the native EtO in the flue gas before and after the spike and the spiked gas dilution factor.

10.1.5.1.2 or each required RATA of an EtO CEMS, record the beginning and ending date and time of each test run, the reference method(s) used, and the reference method and EtO CEMS run values. Keep records of stratification tests performed (if any), all of the raw field data, relevant process operating data, and all of the calculations used to determine the relative accuracy.

10.1.5.1.3 For each required measurement error (ME) test of an EtO monitor, record the date and time of each gas injection, the reference gas concentration (low, mid, or high) and the monitor response for each of the three injections at each of the three levels. Also record the average monitor response and the ME at each gas level and the related calculations.

10.1.5.1.4 For each required level of detection (LOD) test of an EtO monitor performed in a controlled environment, record the test date, the concentrations of the reference gas and interference gases, the results of the seven (or more) consecutive measurements of EtO, the standard deviation, and the LOD value. For each required LOD test performed in the field, record the test date, the three measurements of the native source EtO concentration, the results of the three independent standard addition (SA) measurements known as standard addition response (SAR), the effective spike addition gas concentration, the resulting standard addition detection level (SADL) value and all related calculations. For extractive CEMS performing the SA using dynamic spiking, you must record the spiked gas dilution factor.

10.1.5.1.5 For each required ME/level of detection response time test of an EtO monitor, record the test date, the native EtO concentration of the flue gas, the reference gas value, the stable reference gas readings, the upscale/downscale start and end times, and the results of the upscale and downscale stages of the test.

10.1.5.1.6 For each required interference test of an EtO monitor, record (or obtain from the analyzer manufacturer records of): The date of the test; the gas volume/rate, temperature, and pressure used to conduct the test; the EtO concentration of the reference gas used; the concentrations of the interference test gases; the baseline EtO responses for each interferent combination spiked; and the total percent interference as a function of span or EtO concentration.

10.1.5.1.7 For each quarterly relative accuracy audit (RAA) of an EtO monitor, record the beginning and ending date and time of each test run, the reference method used, the EtO concentrations measured by the reference method and CEMS for each test run, the average concentrations measured by the reference method and the CEMS, and the calculated relative accuracy. Keep records of the raw field data, relevant process operating data, and the calculations used to determine the relative accuracy.

10.1.5.1.8 For each quarterly cylinder gas audit (CGA) of an EtO monitor, record the date and time of each injection, and the reference gas concentration (zero, mid, or high) and the monitor response for each injection. Also record the average monitor response and the calculated ME at each gas level.

10.1.5.1.9 For each quarterly dynamic spiking audit (DSA) of an EtO monitor, record the date and time of the zero gas injection and each spike injection, the results of the zero gas injection, the gas concentrations (mid and high) and the dilution factors and the monitor response for each of the six upscale injections as well as the corresponding native EtO concentrations measured before and after each injection. Also record the average dynamic spiking error for each of the upscale gases, the calculated average DSA Accuracy at each upscale gas concentration, and all calculations leading to the DSA Accuracy.

10.1.5.2 Additional Monitoring Systems. For the stack gas flow rate monitoring systems described in section 3.2 of this appendix, you must keep records of all certification, recertification, diagnostic, and on-going quality-assurance tests of these systems, as specified in § 75.59(a) of this chapter.

11. Reporting Requirements

11.1 General Reporting Provisions. The owner or operator shall comply with the following requirements for reporting EtO emissions from each affected unit (or group of units monitored at a common stack):

11.1.1 Notifications, in accordance with paragraph 11.2 of this section;

11.1.2 Monitoring plan reporting, in accordance with paragraph 11.3 of this section;

11.1.3 Certification, recertification, and QA test submittals, in accordance with paragraph 11.4 of this section; and

11.1.4 Electronic quarterly report submittals, in accordance with paragraph 11.5 of this section.

11.2 Notifications. The owner or operator shall provide notifications for each affected unit (or group of units monitored at a common stack) in accordance with § 63.366.

11.3 Monitoring Plan Reporting. For each affected unit (or group of units monitored at a common stack) using EtO CEMS, the owner or operator shall make electronic and hard copy monitoring plan submittals as follows:

11.3.1 For a sterilization facility that begins reporting hourly EtO concentrations with a previously certified CEMS, submit the monitoring plan information in section 10.1.1.2 of this appendix prior to or concurrent with the first required quarterly emissions report. For a new sterilization facility, submit the information in section 10.1.1.2 of this appendix at least 21 days prior to the start of initial certification testing of the CEMS. Also submit the monitoring plan information in § 75.53(g) of this chapter pertaining to any required flow rate monitoring systems within the applicable timeframe specified in this section, if the required records are not already in place.

11.3.2 Update the monitoring plan when required, as provided in paragraph 10.1.1.1 of this appendix. An electronic monitoring plan information update must be submitted either prior to or concurrent with the quarterly report for the calendar quarter in which the update is required.

11.3.3 All electronic monitoring plan submittals and updates shall be made to the Administrator using CEDRI. Hard copy portions of the monitoring plan shall be kept on record according to section 10.1 of this appendix.

11.4 Certification, Recertification, and Quality-Assurance Test Reporting Requirements. Use CEDRI to submit the results of all required certification, recertification, quality-assurance, and diagnostic tests of the monitoring systems required under this appendix electronically. Submit the test results concurrent with the quarterly electronic emissions report. However, for RATAs of the EtO monitor, if this is not possible, you have up to 60 days after the test completion date to submit the test results; in this case, you may claim provisional status for the emissions data affected by the test, starting from the date and hour in which the test was completed and continuing until the date and hour in which the test results are submitted. If the test is successful, the status of the data in that time period changes from provisional to quality-assured, and no further action is required. However, if the test is unsuccessful, the provisional data must be invalidated and resubmission of the affected emission report(s) is required.

11.4.1 For each daily CD (or calibration error) assessment (including daily calibration transfer standard tests), and for each seven-day calibration drift (CD) test of an EtO monitor, report:

11.4.1.1 Facility ID information;

11.4.1.2 The monitoring component ID;

11.4.1.3 The instrument span and span scale;

11.4.1.4 For each gas injection, the date and time, the calibration gas level (zero or high-level), the reference gas value (ppbv), and the monitor response (ppbv);

11.4.1.5 A flag to indicate whether dynamic spiking was used for the high-level value;

11.4.1.6 Calibration drift (percent of span or reference gas, as applicable);

11.4.1.7 When using the dynamic spiking option, the measured concentration of native EtO before and after each mid-level spike and the spiked gas dilution factor; and

11.4.1.8 Reason for test.

11.4.2 For each RATA of an EtO CEMS, report:

11.4.2.1 Facility ID information;

11.4.2.2 Monitoring system ID number;

11.4.2.3 Type of test (i.e., initial or annual RATA);

11.4.2.4 Reason for test;

11.4.2.5 The reference method used;

11.4.2.6 Starting and ending date and time for each test run;

11.4.2.7 Units of measure;

11.4.2.8 The measured reference method and CEMS values for each test run, on a consistent moisture basis, in appropriate units of measure;

11.4.2.9 Flags to indicate which test runs were used in the calculations;

11.4.2.10 Arithmetic mean of the CEMS values, of the reference method values, and of their differences;

11.4.2.11 Standard deviation, using equation 7 in section 12.6 of PS 19 in appendix B to part 60 of this chapter;

11.4.2.12 Confidence coefficient, using equation 8 in section 12.6 of PS 19 in appendix B to part 60 of this chapter;

11.4.2.13 t-value; and

11.4.2.14 Relative accuracy calculated using equation 11 in section 12.6 of PS 19 in appendix B to part 60 of this chapter.

11.4.3 For each measurement error (ME) test of an EtO monitor, report:

11.4.3.1 Facility ID information;

11.4.3.2 Monitoring component ID;

11.4.3.3 Instrument span and span scale;

11.4.3.4 For each gas injection, the date and time, the calibration gas level (zero, low, mid, or high), the reference gas value in ppbv and the monitor response.

11.4.3.5 For extractive CEMS, the mean reference value and mean of measured values at each reference gas level (ppbv).

11.4.3.6 ME at each reference gas level; and

11.4.3.7 Reason for test.

11.4.4 For each interference test of an EtO monitoring system, report:

11.4.4.1 Facility ID information;

11.4.4.2 Date of test;

11.4.4.3 Monitoring system ID;

11.4.4.4 Results of the test (pass or fail);

11.4.4.5 Reason for test; and

11.4.4.6 A flag to indicate whether the test was performed: On this particular monitoring system; on one of multiple systems of the same type; or by the manufacturer on a system with components of the same make and model(s) as this system.

11.4.5 For each LOD test of an EtO monitor, report:

11.4.5.1 Facility ID information;

11.4.5.2 Date of test;

11.4.5.3 Reason for test;

11.4.5.4 Monitoring system ID;

11.4.5.5 A code to indicate whether the test was done in a controlled environment or in the field;

11.4.5.6 EtO reference gas concentration;

11.4.5.7 EtO responses with interference gas (seven repetitions);

11.4.5.8 Standard deviation of EtO responses;

11.4.5.9 Effective spike addition gas concentrations;

11.4.5.10 EtO concentration measured without spike;

11.4.5.11 EtO concentration measured with spike;

11.4.5.12 Dilution factor for spike;

11.4.5.13 The controlled environment LOD value (ppbv or ppbv-meters);

11.4.5.14 The field determined standard addition detection level (SADL in ppbv or ppbv-meters); and

11.4.5.15 Result of LOD/SADL test (pass/fail).

11.4.6 For each ME or LOD response time test of an EtO monitor, report:

11.4.6.1 Facility ID information;

11.4.6.2 Date of test;

11.4.6.3 Monitoring component ID;

11.4.6.4 The higher of the upscale or downscale tests, in minutes; and

11.4.6.5 Reason for test.

11.4.7 For each quarterly RAA of an EtO monitor, report:

11.4.7.1 Facility ID information;

11.4.7.2 Monitoring system ID;

11.4.7.3 Begin and end time of each test run;

11.4.7.4 The reference method used;

11.4.7.5 The reference method and CEMS values for each test run, including the units of measure;

11.4.7.6 The mean reference method and CEMS values for the three test runs;

11.4.7.7 The calculated relative accuracy, percent; and

11.4.7.8 Reason for test.

11.4.8 For each quarterly cylinder gas audit of an EtO monitor, report:

11.4.8.1 Facility ID information;

11.4.8.2 Monitoring component ID;

11.4.8.3 Instrument span and span scale;

11.4.8.4 For each gas injection, the date and time, the reference gas level (zero, mid, or high), the reference gas value in ppbv, and the monitor response.

11.4.8.5 For extractive CEMS, the mean reference gas value and mean monitor response at each reference gas level (ppbv).

11.4.8.6 ME at each reference gas level; and

11.4.8.7 Reason for test.

11.4.9 For each quarterly DSA of an EtO monitor, report:

11.4.9.1 Facility ID information;

11.4.9.2 Monitoring component ID;

11.4.9.3 Instrument span and span scale;

11.4.9.4 For the zero gas injection, the date and time, and the monitor response (Note: The zero gas injection from a calibration drift check performed on the same day as the upscale spikes may be used for this purpose.);

11.4.9.5 Zero spike error;

11.4.9.6 For the upscale gas spiking, the date and time of each spike, the reference gas level (mid- or high-), the reference gas value (ppbv), the dilution factor, the native EtO concentrations before and after each spike, and the monitor response for each gas spike;

11.4.9.7 Upscale spike error;

11.4.9.8 DSA at the zero level and at each upscale gas level; and

11.4.9.9 Reason for test.

11.4.10 Reporting Requirements for Diluent Gas, Flow Rate, and Moisture Monitoring Systems. For the certification, recertification, diagnostic, and QA tests of stack gas flow rate, moisture, and diluent gas monitoring systems that are certified and quality-assured according to part 75 of this chapter, report the information in section 10.1.8.2 of this appendix.

11.5 Quarterly Reports.

11.5.1 The owner or operator of any affected unit shall use CEDRI to submit electronic quarterly reports to the Administrator in an XML format specified by the Administrator, for each affected unit (or group of units monitored at a common stack). If the certified EtO CEMS is used for the initial compliance demonstration, EtO emissions reporting shall begin with the first operating hour of the 30-operating day compliance demonstration period. Otherwise, EtO emissions reporting shall begin with the first operating hour after successfully completing all required certification tests of the CEMS.

11.5.2 The electronic reports must be submitted within 30 days following the end of each calendar quarter, except for units that have been placed in long-term cold storage.

11.5.3 Each electronic quarterly report shall include the following information:

11.5.3.1 The date of report generation;

11.5.3.2 Facility identification information;

11.5.3.3 The information in sections 10.1.2 through 10.1.4 of this appendix, as applicable to the type(s) of monitoring system(s) used to measure the pollutant concentrations and other necessary parameters.

11.5.3.4 The results of all daily calibrations (including calibration transfer standard tests) of the EtO monitor as described in section 10.1.8.1.1 of this appendix; and

11.5.3.5 If applicable, the results of all daily flow monitor interference checks, in accordance with section 10.1.8.2 of this appendix.

11.5.4 Compliance Certification. Based on reasonable inquiry of those persons with primary responsibility for ensuring that all EtO emissions from the affected unit(s) have been correctly and fully monitored, the owner or operator shall submit a compliance certification in support of each electronic quarterly emissions monitoring report. The compliance certification shall include a statement by a responsible official with that official's name, title, and signature, certifying that, to the best of his or her knowledge, the report is true, accurate, and complete.