§ 63.366 - Reporting requirements.

§ 63.366 Reporting requirements.

(a) General requirements. The owner or operator of a an affected source subject to the emissions standards in § 63.362 shall must fulfill all reporting requirements in §§ § 63.10(a), (d), (e), and (f) of subpart A, according to the applicability in Table 1 of § 63.360. table 6 to this subpart. These reports will be made to the Administrator at the appropriate address identified in § 63.13 of subpart A of this part or submitted electronically.

(

1) Reports required by subpart A and this section may be sent by U.S. mail, fax, or by another courier.

(i) Submittals sent by U.S. mail shall be postmarked on or before the specified date.

(ii) Submittals sent by other methods shall be received by the Administrator on or before the specified date.

(2) If acceptable to both the Administrator and the owner or operator of a source, reports may be submitted on electronic media.

(3) Content and submittal dates for deviations and monitoring system performance reports. All deviations and monitoring system performance reports and all summary reports, if required per § 63.10(e)(3)(vii) and (viii), shall be delivered or postmarked

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

half or

quarter

as appropriate (see § 63.10(e)(3)(i) through (iv) for applicability). Written reports

. 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 1 of § 63.360

table 6 to this subpart, and information from any calibration tests in which the monitoring equipment is not in compliance with

PS 9

Performance Specification 19 in appendix B and Procedure 7 in appendix F to part 60 of this chapter or the method used for

temperature

parameter monitoring device calibration.

The written report

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:

(

b) Construction and reconstruction. The owner or operator of each source using 10 tons shall

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

source

facility in § 63.5

of subpart A of this part

, according to the applicability in

Table 1 of § 63.360

table 6 to this subpart, and in this paragraph.

(1) Applicability.

(i) This paragraph (d) and § 63.5

of subpart A of this part

implement the preconstruction review requirements of section 112(i)(1) for

sources

facilities subject to these emissions standards. In addition, this paragraph (d) and § 63.5

of subpart A of this part

include other requirements for constructed and reconstructed

sources

facilities that are or become subject to these emissions standards.

(ii) After

the effective date,

April 5, 2024, the requirements in this section and in § 63.5

of subpart A of this part

apply to owners or operators who construct a new

source

facility or reconstruct a

source

facility subject to these emissions standards after

December 6

April 5,

1994

2024. New or reconstructed

sources

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)

of subpart A of this part

.

(2)

After the effective date,

Advance approval. After April 5, 2024, whether or not an approved permit program is effective in the

State

jurisdictional authority in which a

source

facility is (or would be) located, no person may construct a new

source

facility or reconstruct a

source

facility subject to these emissions standards, or reconstruct a

source

facility such that the

source

facility becomes a

source

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)

of subpart A of this part

.

(3) Application for approval of construction or reconstruction. The provisions of paragraph (b)(3) of this section and § 63.5(d)(3) and (4)

of subpart A of this part

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

source

facility subject to these emissions standards, the reconstruction of a

source

facility subject to these emissions standards, or the reconstruction of a

source

facility such that the

source

facility becomes a

source

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 (

c

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

source

facility subject to these emissions standards or make any physical or operational change to a

source

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

of subpart A of this part

.

(3) The address (i.e., physical location) or proposed address of the

source

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

source

facility.

(8) The type and quantity of hazardous air pollutants emitted by the

source

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

source

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)

of subpart A of this part

.

(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

source

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

State

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)

of subpart A of this part

if the owner or operator of a new or reconstructed

source

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

source

facility subject to these emissions standards has undergone a preconstruction review and approval process in the

State

jurisdictional authority in which the

source

facility is (or would be) located before the effective date and has received a federally enforceable construction permit that contains a finding that the

source

facility will meet these emissions standards as proposed, if the

source

facility is properly built and operated;

(B) In making its finding, the

State

jurisdictional authority has considered factors substantially equivalent to those specified in § 63.5(e)(1)

of subpart A of this part

.

(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

of subpart A of this part

. The Administrator may request additional relevant information after the submittal of a request for approval of construction or reconstruction.

(

c

e) Notification requirements. The owner or operator of

each

an affected source subject to

the

an emissions

standards

standard in § 63.362 shall fulfill all notification requirements in § 63.9

of subpart A of this part

, according to the applicability in

Table 1 of § 63.360

table 6 to this subpart, and in this paragraph (e).

(1) Initial notifications.

(i)

(A) If a source that otherwise would be subject to these emissions standards subsequently increases its use of ethylene oxide within any consecutive 12-month period after December 6, 1996, such that the source becomes subject to these emissions standards or other requirements, such source shall be subject to the notification requirements of § 63.9 of subpart A of this part.

(B) Sources subject to these emissions standards

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 (

b

d)(3)(ii) of this section and § 63.5(d)(3)

of subpart A of this part

, respectively, if relevant to fulfill the initial notification requirements.

(ii) The owner or operator of a new or reconstructed

source

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 (

b

d)(3) of this section and § 63.5(d)(3) and (4)

of subpart A of this part

shall provide the following information in writing to the Administrator:

(A) A notification of intention to construct a new

source

facility subject to these emissions standards, reconstruct a

source

facility subject to these emissions standards, or reconstruct a

source

facility such that the

source

facility becomes a

source

facility subject to these emissions standards with the application for approval of construction or reconstruction as specified in paragraph (

b

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

not

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

source

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

source

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

State

jurisdictional authority in which a

source

facility subject to these emissions standards is (or would be) located, an owner or operator who intends to construct a new

source

facility subject to these emissions standards or reconstruct a

source

facility subject to these emissions standards, or reconstruct a

source

facility such that it becomes a

source

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 (

b

d)(3) of this section and § 63.5(d)(3) and (4)

of subpart A of this part

. For

sources

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

of subpart A of this part

.

(2) If an owner or operator of a

source

facility subject to these emissions standards submits estimates or preliminary information in the application for approval of construction or reconstruction required in paragraph (

b

d)(3)(ii) of this section and § 63.5(d)(3)

of subpart A of this part

, respectively, in place of the actual emissions data or control efficiencies required in paragraphs (

b

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)

The owner or operator of any existing sterilization facility subject to this subpart shall

If you own or operate an affected source subject to an emissions standard in § 63.362, you must also include the amount of

ethylene oxide

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)

of subpart A of this part

. For new sterilization facilities subject to this subpart, the amount of

ethylene oxide

EtO used at the facility shall be an estimate of expected use during the first consecutive 12-month period of operation.

[59 FR 62589, Dec. 6, 1994, as amended at 66 FR 55585, Nov. 2, 2001]

(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.