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:
(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:
(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;