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OMB Control No: 2060-0422	ICR Reference No: 202301-2060-009
Status: Active	Previous ICR Reference No: 201905-2060-019
Agency/Subagency: EPA/OAR	Agency Tracking No: 1899.10
Title: EG for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH) (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/30/2024
	Date Received in OIRA: 01/31/2023
Terms of Clearance: In accordance with 5 CFR 1320, EPA is required to include the following information in its submission for information collection request review and approval: (1) supporting statements to show compliance with PRA requirements and other associated laws; (2) a description of the regulatory text applicable to the ICR including submission specifications; (3) a clear description of the data elements being collected under the ICR; (4) copies of the data collection instrument(s) and/or screen shots of the electronic portal where the reporting requirements are submitted to EPA (with the control number and burden statement included); (5) a detailed discussion of how information is submitted and the extent to which electronic reporting is available; (6) evidence of consultation with respondents (by actively reaching out to stakeholders as permitted by the PRA) to ensure the supporting statement's accuracy on availability of data, frequency of collection, clarity of instructions, accuracy of burden estimate, relevance of data elements, and similar PRA matters; and (7) discussion of how EPA addressed substantive concerns raised by respondents and other stakeholders during consultation and in response to comments received on FR notices. In addition, supporting statement A should use the standard 18 question SS-A format. More information can be found at https://pra.digital.gov/clearance-process/supporting-statement/.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	07/31/2024
Responses	85	0	173
Time Burden (Hours)	19,178	0	38,800
Cost Burden (Dollars)	237,329	0	479,000

Abstract: The Emission Guidelines (EG) (40 CFR Part 60, Subpart Ce) for Hospital/Medical/ Infectious Waste Incinerators were proposed on February 27, 1995; promulgated on September 15, 1997; and revised on both October 6, 2009 and April 4, 2011. The Federal Plan Requirements for these regulations (40 CFR Part 62, Subpart HHH) were proposed on July 6, 1999; promulgated on August 15, 2000; and revised on May 13, 2013. Subpart Ce requires either states or tribes to develop plans to implement the EG. If approvable state or tribal plans were not developed, the EPA was required to develop a Federal plan (Subpart HHH) to implement the Emission Guidelines for such states and tribes. The Federal plan is an interim measure to ensure that emissions standards are implemented until states assume their role as the preferred implementers of the EG. The 2013 rule finalized amendments to the HMIWI federal plan to implement the amended EG adopted on October 6, 2009, for those states that did not have an approved revised/new state plan in place within 2 years after promulgation of the EG. The regulations in 40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH apply to each existing individual hospital/medical/infectious waste incinerator (HMIWI) that either commenced construction prior to December 2, 2008 or commenced modification prior to April 6, 2010. This information is being collected to assure compliance with 40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH. In general, all Emission Guidelines require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to the Emission Guidelines.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	85	173	-88
Annual Time Burden (Hours)	19,178	38,800	-19,622
Annual Cost Burden (Dollars)	237,329	479,000	-241,671

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The decrease in burden from the most-recently approved ICR is due to a decrease in the number of sources due to a decline in the industry. This decrease is not due to any program changes. The number of sources has declined as HMIWI units have closed. Any new units that either commence construction after December 2, 2008 or commence modification after April 6, 2010 are subject to the new source performance standards at 40 CFR Part 60, Subpart Ec. The decrease in the operation and maintenance costs from the currently-approved ICR is also due to the decline in the number of HMIWI units. There are no changes to the capital costs because there are no new entities subject to 40 CFR Part 60, Subpart Ce or 40 CFR Part 62, Subpart HHH.

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