§63.362. Standards. — Inbound Citations

(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.

(c) 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).

(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.

(1) 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.

(a) 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.

(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.

(1) Approval of alternatives to the requirements in §§ 63.360 and 63.362.

(b) 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.

(d) 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).

(b) 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.

(b) 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.

(d) 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).

(b) 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.

(d) 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).

(b) 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.

(d) 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).

(b) 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.

(d) 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).

(b) 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.

(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).

(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) 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) 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.

(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

(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.

(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.

(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.

(b) 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.

(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

(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.

(1) 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.

(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.

(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.

(1) 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.

(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.

(1) 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.

(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) 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.

(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.

(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.

(2) 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.

(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.

(2) 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.

(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.

(b) 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.

(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.