18Q Supporting Statement Instructions_draft

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U.S. Environmental Protection Agency
Information Collection Request

Title: NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)
OMB Control Number: 2060-0363
EPA ICR Number: 1730.13
Abstract: The New Source Performance Standards (NSPS) for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) were proposed on February 27, 1995; promulgated on September 15, 1997; and amended on: October 6, 2009; April 4, 2011; and May 12, 2013. The original standards applied to either owners or operators of Hospital/Medical/Infectious Waste Incinerators (HMIWI) for which construction commenced after June 20, 1996, or for which modification commenced after March 16, 1998, but no later than April 6, 2010. Sources subject to the original standards are now covered under the revised Emission Guidelines for HMIWI at 40 CFR Part 60, Subpart Ce. This information request covers the reporting and recordkeeping requirements associated with the revised NSPS, which apply to new facilities only. New facilities include those that commenced either construction after December 1, 2008, or commenced modification after April 6, 2010. This information is being collected to assure compliance with 40 CFR Part 60, Subpart Ec. 
In general, all NSPS standards 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 NSPS. 
The Office of Management and Budget (OMB) approved the currently active ICR without any “Terms of Clearance.”
Supporting Statement A
    1. NEED AND AUTHORITY FOR THE COLLECTION
Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.
The EPA is charged under Section 111 of the Clean Air Act (CAA), as amended, to establish standards of performance for new stationary sources that reflect: 
. . . application of the best technological system of continuous emissions reduction which (taking into consideration the cost of achieving such emissions reduction, or any non-air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated. Section 111(a)(l).
The Agency refers to this charge as selecting the best demonstrated technology (BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every eight years. In addition, section 114(a) states that the Administrator may require any owner/operator subject to any requirement of this Act to: 
(A) Establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); (E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; (F) submit compliance certifications in accordance with Section 114(a)(3); and (G) provide such other information as the Administrator may reasonably require.
In the Administrator's judgment, dioxin/furan, particulate matter (PM), carbon monoxide (CO), hydrogen chloride (HCl), sulfur dioxide (SO2), nitrogen oxides (NOx), lead (Pb), cadmium (Cd), and mercury (Hg) emissions from HMIWI either cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NSPS were promulgated for this source category at 40 CFR Part 60, Subpart Ec. 
    2. PRACTICAL UTILITY/USERS OF THE DATA
Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.
The recordkeeping and reporting requirements in the standards ensure compliance with the applicable regulations which were promulgated in accordance with the Clean Air Act. The collected information is also used for targeting inspections and as evidence in legal proceedings.
Performance tests are required in order to determine an affected facility’s initial capability to comply with these emission standards. Continuous emission monitors are used to ensure compliance with these same standards at all times. During the performance test a record of the operating parameters under which compliance was achieved may be recorded and used to determine compliance in place of a continuous emission monitor.
The notifications required in these standards are used to inform either the Agency or its delegated authority when a source becomes subject to the requirements of these regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated, leaks are being detected and repaired. and that the same standards are being met. The performance test may also be observed.
The required annual and semiannual reports are used to determine periods of excess emissions, identify problems at the facility, verify operation/maintenance procedures, and for compliance determinations.
    3. USE OF TECHNOLOGY
Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.
Some of the respondents are using monitoring equipment that automatically records parameter data. Although personnel at the affected facility must still evaluate the data, internal automation has significantly reduced the burden associated with monitoring and recordkeeping at a plant site.
    4. EFFORTS TO IDENTIFY DUPLICATION
Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.
For reports required to be submitted electronically, the information is sent through the EPA's CDX, using CEDRI, where the appropriate EPA regional office can review it, as well as state and local agencies that have been delegated authority. If a state or local agency has adopted under its own authority its own standards for reporting or data collection, adherence to those non-Federal requirements does not constitute duplication. 
For all other reports, if the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted its own standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, duplication does not exist. 
    5. MINIMIZING BURDEN ON SMALL BUSINESSES AND SMALL ENTITIES
If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.
There are no small entities (i.e., small businesses) affected by this regulation. However, the impact on small entities (i.e., small businesses) was taken into consideration during the development of this regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these to be the minimum requirements needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.
    6. CONSEQUENCES OF LESS FREQUENT COLLECTION
Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the proper operation and maintenance of control equipment and the possibility of detecting violations would be less likely.
    7. GENERAL GUIDELINES
Explain any special circumstances that require the collection to be conducted in a manner inconsistent with OMB guidelines.
These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR Part 1320, Section 1320.5.
These standards require the respondents to maintain all records, including reports and notifications for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five-year records retention requirement is consistent with the Part 70 permit program and the five-year statute of limitations on which the permit program is based. The retention of records for five years allows EPA to establish the compliance history of a source, any pattern of non-compliance and to determine the appropriate level of enforcement action. EPA has found that the most flagrant violators have violations extending beyond five years. In addition, EPA would be prevented from pursuing the violators due to the destruction or nonexistence of essential records.
    8. PUBLIC COMMENT AND CONSULTATIONS
8a. Public Comment
If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the Agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the Agency in response to these comments. Specifically address comments received on cost and hour burden.
An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (89 FR 63933) on August 6, 2024. No comments were received on the burden published in the Federal Register for this renewal.
8b. Consultations
Describe efforts to consult with persons outside the Agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported. Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.
The Agency has consulted industry experts and internal data sources to project the number of affected facilities and industry growth over the next three years. The primary source of information as reported by industry, in compliance with the recordkeeping and reporting provisions in the standard, is the Integrated Compliance Information System (ICIS). ICIS is EPA’s database for the collection, maintenance, and retrieval of compliance data for industrial and government-owned facilities. The growth rate for the industry is based on our consultations with the Agency’s internal industry experts. Approximately three respondents will be subject to the standard over the three-year period covered by this ICR.
Industry trade association(s) and other interested parties were provided an opportunity to comment on the burden associated with the standard as it was being developed and the standard has been previously reviewed to determine the minimum information needed for compliance purposes. In developing this ICR, we contacted both the National Waste & Recycling Association, and Stericycle. In this case, no comments were received.
It is our policy to respond after a thorough review of comments received since the last ICR renewal as well as those submitted in response to the first Federal Register notice. In this case, no comments were received.
    9. PAYMENTS OR GIFTS TO RESPONDENTS
Explain any decisions to provide payments or gifts to respondents, other than remuneration of contractors or grantees.
No payments or gifts are made to respondents.
    10. ASSURANCE OF CONFIDENTIALITY
Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or Agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.
Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, subpart B - Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).
    11. JUSTIFICATION FOR SENSITIVE QUESTIONS
Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the Agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
The reporting or recordkeeping requirements in the standard do not include sensitive questions.
    12. RESPONDENT BURDEN HOURS & LABOR COSTS
Provide estimates of the hour burden of the collection of information. The statement should:
    • Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Generally, estimates should not include burden hours for customary and usual business practices.
    • If this request for approval covers more than one form, provide separate hour burden estimates for each form and the aggregate the hour burdens.
    • Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included as O&M costs under non-labor costs covered under question 13.

12a. Respondents/NAICS Codes
The respondents to the recordkeeping and reporting requirements are owners and operators of HMIWI. The United States Standard Industrial Classification (SIC) codes and the corresponding North American Industry Classification System (NAICS) codes for the respondents affected by the standards are listed in the table below: 

Standard (40 CFR Part 60, Subpart Ec)

SIC Codes

NAICS Codes
General Medical and Surgical Hospitals
8062
622110
Specialty Hospitals
8069
622310
Medicinal and Botanical Manufacturing
2833
325411
Pharmaceutical Preparation Manufacturing
2834
325412
Solid Waste Combustors and Incinerators
4953
562213
Colleges, Universities, and Professional Schools
8221
611310
Research and Development in Physical, Chemical, and Life Sciences
8731, 8733
541710
National Security
9711
928110
Public Health Facility
9431
923120

Based on our research for this ICR, on average over the next three years, approximately three existing respondents will be subject to the standard. It is estimated that no additional respondents per year will become subject, for an overall total of three respondents per year. The number of respondents is calculated using the table Number of Respondents that addresses the three years covered by this ICR. None of the facilities in the United States are owned by either state, local, or tribal entities or by the Federal government. They are all owned and operated by privately-owned, for-profit businesses. We assume that they will all respond to EPA inquiries. Based on our consultations with industry representatives, there is an average of one affected facility at each plant site and each plant site has only one respondent (i.e., the owner/operator of the plant site).
The total number of annual responses per year is calculated using the table Total Annual Responses shown below. The number of Total Annual Responses is 17 (rounded).

12b. Information Requested
In this ICR, all the data that are recorded or reported is required by the NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec). Any owner/operator subject to the provisions of this part shall maintain a file of these measurements and retain the file for at least five years following the date of such measurements, maintenance reports, and records.
A source must make the following reports:

Notifications
Notification and application of construction or modification
§60.58c(a), §60.7(a)
Notification of anticipated startup
§60.58c(a), §60.7(a)
Notification of actual startup
§60.7(a)
Notification of type(s) of waste to be combusted
§60.58c(a)(2)(i)
Notification of HMIWI capacity
§60.58c(a)(2)(ii)
Notification of initial continuous monitoring system (CMS) demonstration (including CO CEMS)
§60.7(a)
Notification of initial performance test
§60.8(d)
Notification of exemption claim for combustors burning pathological, low-level radioactive, and/or chemotherapeutic waste
§60.50c(b)(1)
Notification of exemption claim for co-fired combustors
§60.50c(c)(1)


Reports
Statement of intent to construct/modify
§60.58c(a)(1)(i)
Documentation produced as a result of the siting requirements
§60.58c(a)(1)(iv), §60.54c(c)
Waste management plan
§60.58c(c)(3), §60.55c
Analysis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection systems
§60.58c(c)(4)
Report of initial performance tests
§60.58c(d)(6), §60.8(a)
Initial report of values for site-specific operating parameters
§60.58c(c)(2), §60.7(a)
Annual report of values for site-specific operating parameters
§60.58c(d)(1)
Annual and semiannual reports of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained
§60.58c(d), §60.58c(e), §60.7(c)
Annual report of no excess emissions
§60.58c(d)(7), §60.7(c)
Report of results of annual performance test
§60.58c(d)(6)
Annual report of control equipment inspection
§60.58c(d)

A source must keep the following records:

Recordkeeping
Retention of records for 5 years
§60.58c(b)
Records of startup, shutdown, or malfunction
§60.7(b)
Documentation produced as a result of siting requirements
§60.58c(b)(7)
Records of operators completing review of HMIWI operating manual
§60.58c(b)(8)
Records of operators completing operator training course and qualification requirements
§60.58c(b)(9)-(10)
Records of initial and annual testing of fugitive ash emissions
§60.58c(b)(2)(ii)
Records of process and control device operating parameters
§60.58c(b)(2)(iii)(xix)
Records of CMS operation and maintenance (including CO CEMS)
§60.7(f)
Records of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained
§60.58c(b)(3)-(5)
Records of initial, annual, and any subsequent performance tests
§60.58c(b)(6)
Records of calibration of monitoring devices (including CO CEMS)
§60.58c(b)(11)
Records of annual control equipment inspections, required maintenance, and repairs not completed during established timeframe
§60.58c(b)(2)(xvii)
Records of bag leak detection system alarms and corrective action taken
§60.58c(b)(2)(xviii)
Records of CO concentrations from CO CEMS
§60.58c(b)(2)(xix)
Records on quarterly basis of types and amounts of materials charged for co-fired combustors and for incinerators burning only pathological, low-level radioactive, and/or chemotherapeutical waste
§60.50c(b), (c)

12c. Respondent Activities

Respondent Activities
Familiarization with the regulatory requirements.

Install, calibrate, maintain, and operate CEMS where used for demonstrating compliance with emission standards for control of PM, HCl, multi-metals, and Hg. This includes CEMS for opacity, pressure drop, and liquid supply pressure for any baghouses or wet scrubbers used.

Perform initial performance test, Reference Methods 1, 3, 3A, or 3B, 5, 6 or 6C, 7 or 7E, 9, 10, 22, 23, 26 or 26A, 29, and ASME PTC-19-10-1981-Part 10 tests, and repeat performance tests if necessary.
Write the notifications and reports listed above.
Enter information required to be recorded above.
Submit the required reports developing, acquiring, installing, and utilizing technology and systems for collecting, validating, and verifying information.
Develop, acquire, install, and utilize technology and systems for processing and maintaining information.
Develop, acquire, install, and utilize technology and systems for disclosing and providing information.
Train personnel to be able to respond to a collection of information.
Transmit, or otherwise disclose the information.

12d. Respondent Burden Hours and Labor Costs
Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.
The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 1,780 hours (Total Labor Hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.
This ICR uses the following labor rates:
Managerial	$172.41 ($82.10 + 110%) 
Technical	$141.75 ($67.50 + 110%)
Clerical		$71.36 ($33.98 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2023, “Table 2. Civilian workers by occupational and industry group.” The rates are from column 1, “Total compensation.” The rates are increased by 110 percent to account for varying industry wage rates and the additional overhead business costs of employing workers beyond their wages and benefits, including business expenses associated with hiring, training, and equipping their employees.
We assume that burdens for managerial tasks take 5% of the time required for technical tasks because the typical tasks for managers are to review and approve reports. Clerical burdens are assumed to take 10% of the time required for technical tasks because the typical duties of clerical staff are to proofread the reports, make copies and maintain records.
    13. Respondent CAPITAL AND O&m CostS 
Provide an estimate for the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should consider costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling, and testing equipment; and record storage facilities. If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. 
Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

The type of industry costs associated with the information collection activities in the subject standard(s) are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring. The capital/startup costs are one-time costs when a facility becomes subject to this regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitor(s) and other costs such as photocopying and postage.
The total capital/startup costs for this ICR is $0. This is the total of column D shown below in the table Capital/Startup vs. Operation and Maintenance (O&M) Costs. 
The total operation and maintenance (O&M) costs for this ICR are $ 177,000. This is the total of column G shown below in the table Capital/Startup vs. Operation and Maintenance (O&M) Costs.
The average annual cost for capital/startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $177,000.
    14. AGENCY COSTS
Provide estimates of annualized costs to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information.
14a. Agency Activities
The EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information:
•	Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.
•	Audit facility records.
•	Input, analyze, and maintain data in the Enforcement and Compliance History Online (ECHO) and ICIS.
Following notification of startup, the reviewing authority could inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source’s initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.
Information contained in the reports is reported by state and local governments in the ICIS Air database, which is operated and maintained by EPA's Office of Compliance. EPA uses ICIS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.
14b. Agency Labor Cost
The ‘burden’ to the Federal Government is attributed entirely to work performed by either Federal employees or government contractors. The only costs to the Agency are those costs associated with analysis of the reported information. The EPA's overall compliance and enforcement program includes such activities as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information. The average annual Agency burden and cost during the three years of the ICR is estimated to be 135 hours at a cost of $7,510. See Table 2: Average Annual EPA Burden and Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
This cost is based on the average hourly labor rate as follows:
		Managerial	$76.91 (GS-13, Step 5, $48.07 + 60%)
		Technical	$57.07 (GS-12, Step 1, $35.67 + 60%)
		Clerical		$30.88 (GS-6, Step 3, $19.30+ 60%)
These rates are from the Office of Personnel Management (OPM), 2024 General Schedule, which excludes locality, rates of pay. The rates have been increased by 60 percent to account for the benefit packages available to government employees. Details upon which this estimate is based appear at the end of this document in Table 2: Average Annual EPA Burden and Cost –NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
14c. Agency Non-Labor Costs
There are no non-labor costs to the Agency associated with this information collection.
    15) REASONS FOR CHANGE IN BURDEN
Explain the reasons for any program changes or adjustments reported in the burden or capital/O&M cost estimates.

There is no change in burden from the most recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. This is due to two considerations. First, the regulations have not changed over the past three years and are not anticipated to change over the next three years. Second, the growth rate for this industry is very low or non-existent, so there is no significant change in the overall burden. There is a slight increase in labor costs, which is wholly due to the use of updated labor rates. The capital and operation & maintenance (O&M) costs were increased using the CEPCI CE Index. The overall result is an increase in the capital and O&M costs.
    16) PUBLICATION OF DATA
For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
Although this rule does not require electronic reporting, respondents could choose to submit notifications or reports electronically. All non-CBI data submitted electronically to the Agency through CEDRI are available to the public for review and printing and are accessible using WebFIRE. Electronically submitted emissions data from performance testing or performance evaluations using the Electronic Reporting Tool or templates attached to CEDRI, as well as data from reports from regulations with electronic templates, are tabulated; data submitted as portable document format (PDF) files attached to CEDRI are neither tabulated nor subject to complex analytical techniques. Electronically submitted emissions data used to develop emissions factors undergo complex analytical techniques and the draft emissions factors are available on the Clearinghouse for Inventories and Emission Factors listserv at https://www.epa.gov/chief/chief-listserv for public review and printing. Electronically submitted emissions data, as well as other data, obtained from one-time or sporadic information collection requests often undergo complex analytical techniques; results of those activities are included in individual rulemaking dockets and are available at https://www.regulations.gov/ for public review and printing.
    17) DISPLAY OF EXPIRATION DATE 
If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.
EPA will display the expiration date for OMB approval of the information collection.
    18) CERTIFICATION STATEMENT
Explain each exception to the topics of the certification statement identified in “Certification for Paperwork Reduction Act Submissions.”
There are no exceptions to the topics of the certification statement.

Table 1: Annual Respondent Burden and Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)
Burden item
(A)
Person hours per occurrence
(B)
No. of occurrences per respondent per year
(C)
Person hours per respondent per year
(C=AxB)
(D)
Respondents per year a
(E)
Technical person- hours per year
(E=CxD)
(F)
Management person hours per year
(Ex0.05)
(G)
Clerical person hours per year
(Ex0.1)
(H)
Total Cost
Per year b
1. Applications
N/A







2. Survey and Studies
N/A







3. Reporting requirements








 A. Familiarization with the regulatory requirement
1
1
1
3
3
0.15
0.30
$472.52
 B. Required activities








 Perf spec tests (certif) for CMS
16
1
16
0
0
0.00
0.00
$0.00
 Repeat perf spec tests (certif) for CMS c,d
16
1
16
0
0
0
0
$0
 Development of operating information e
160
1
160
0
0
0
0
$0.00
 Annual update of operating information f
20
1
20
3
60
3
6
$9,450.39
 Review of operating information with each operator g,h
8
2
16
3
48
2.4
4.8
$7,560.31
 Initial control equipment inspection i
20
1
20
0
0
0
0
$0.00
 Annual control equipment inspection i
20
1
20
3
60
3
6
$9,450.39
 C. Create information
See 3B







 D. Gather existing information
See 3B







 E. Write reports








 Notification of intent to construct f
2
1
2
0
0
0
0
$0.00
 Notification of anticipated commencement of 
 construction g
2
1
2
0
0
0
0
$0.00
 Notification of anticipated startup g
2
1
2
0
0
0
0
$0.00
 Notification of actual startup g
2
1
2
0
0
0
0
$0.00
 Notification of type(s) of waste to be combusted
2
1
2
0
0
0
0
$0.00
 Notification of HMIWI capacity
2
1
2
0
0
0
0
$0.00
 Notification of initial performance test h
2
1
2
0
0
0
0
$0.00
 Notification of initial CMS demonstration
2
1
2
0
0
0
0
$0.00
 Initial report for the site selection analysis j
460
1
460
0
0
0
0
$0.00
 Waste management plan k
160
1
160
0
0
0
0
$0.00
 Analysis and supporting documentation 
 demonstrating conformance with EPA guidance 
 and specifications for bag leak detection systems l
40
1
40
0
0
0
0
$0.00
 Report of initial performance test m
8
1
8
0
0
0
0
$0.00
 Report of initial CMS demonstration m
See 3B







 Annual report








 CMS emissions/operation parameters n
32
1
32
3
96
4.8
9.6
$15,120.62
 Exceedances/ malfunctions/periods of which 
 data not obtained q,p
48
1
48
0.6
28.8
1.44
2.88
$4,536.19
 Results of performance tests conducted during 
 the year q
40
1
40
3
120
6
12
$18,900.78
 Report of no exceedances q,p
24
1
24
2.4
57.6
2.88
5.76
$9,072.37
 Report of annual control equipment inspection
See 3B







 Semiannual report of exceedances/ 
 malfunctions/periods for which data not obtained q,p,r
48
1
48
0.6
28.8
1.44
2.88
$4,536.19
Subtotal for Reporting Requirements




578
$79,100
4. Recordkeeping requirements








 A. Familiarize with regulatory requirement
See 3A







 B. Plan activities
N/A







 C. Implement activities
N/A







 D. Develop record system
N/A







 E. Time to enter information








 Documentation produced as a result of sitting 
 requirements
See 3E







 Records of operators completing operator training 
 requirements h
2
2
4
3
12
0.60
1.20
$1,890.08
 Records of operators that have been qualified as 
 HMIWI operators h
2
2
4
3
12
0.60
1.20
$1,890.08
 Records of initial performance test
See 3E







 Records of startup, shutdown, or malfunction
1.5
52
78
3
234
11.7
23.4
$36,856.52
 Records of persons completing review of operating 
 information h
2
2
4
3
12
0.6
1.2
$1,890.08
 Records of process and control device operating 
 parameters
1.5
52
78
3
234
11.70
23.4
$36,856.52
 Records of CMS operation and maintenance g
0.03
365
9.13
3
27.38
1.37
2.74
$4,311.74
 Records of exceedances/malfunctions/periods for 
 which data not obtained
1.5
52
78
3
234
11.7
23.4
$36,856.52
 Records of annual and any subsequent compliance 
 tests
See 3E







 Records of annual control equipment inspections
See 3B







 Records of bag leak detection system alarms l
1.5
52
78
2
156
7.80
15.60
$24,571.01
 F. Time to train personnel t
40
1
40
3
120
6
12
$18,900.78
 G. Time for audits
N/A







Subtotal for Recordkeeping Requirements




1,198
$164,023
Total Labor Burden and Costs (rounded) u




1,780
$243,000
Capital and O&M Cost (rounded) u







$177,000
GRAND TOTAL (rounded) u







$420,000
Assumptions:








a We have assumed that the average number of sources that are subject to the standard will be 3, with no additional new sources projected over the next 3 years.
b This ICR uses the following labor rates: Managerial $172.41 ($82.10+ 110%); Technical $141.75 ($67.50 + 110%); and Clerical $71.36 ($33.98 + 110%). These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2023, “Table 2. Civilian workers by occupational and industry group.” The rates are from column 1, “Total compensation.” The rates are increased by 110 percent to account for varying industry wage rates and the additional overhead business costs of employing workers beyond their wages and benefits, including business expenses associated with hiring, training, and equipping their employees.
c We assume that performance specification to certify CMS is expected to take approximately 16 hours.
d We assume no failures of the initial CMS demonstrations; includes CO CEMS.
e We assume it will take 160 hours to develop the operating information.
f We assume that it will take 20 hours to update the operating information each year.
g We assume that it will take 8 hours to review the operating information with each operator.
h We assume that it will take 2 operators per facility to enter information.
i We assume that annual control equipment inspection will occur for all sources.
j We assume that it will take 460 hours to develop the site selection analysis.
k We assume that it will take 160 hours to develop the waste management plan.
l We assume that it will take 40 hours to develop the bag leak detection system analysis and 1.5 hours to record bag leak detection system alarms. We assume the total number of sources will be evenly distributed among small, medium, and large sources and only new large and medium sources (i.e. two-thirds of the affected sources) will install baghouses.
m We assume that it will take 8 hours for each facility to review the report of the initial performance test for pollutants and fugitive ash.
n Person-hours per occurrence are assumed to be 32 hours.
o We have assume that it will take 48 hours and 24 hours per report per affected facility to report monitoring exceedances and no excess emissions, respectively. Because testing and monitoring requirements focus primarily on three pollutants (PM, CO, and HCl), assume three pollutants.
p Assume 20 percent of respondents report monitoring exceedances and 80 percent report no excess emissions.
q Assume 40 hours to review report of annual compliance test.
r Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods for which data were not obtained, the frequency of the semiannual report is shown in the table as only once per year to avoid double-counting.
s We assume that this activity will be recorded daily.
t We assumed that it will take 40 hours once per year to train one person to perform the Method 9 and Method 22 tests. The labor requirements to train the personnel were estimated to be 8 hr/d for 5 d/yr.
uTotals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.


Table 2: Average Annual EPA Burden and Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)
Activity
(A)
EPA Person hours per occurrence
(B)
No. of occurrences per respondent per year
(C)
Person hours per respondent per year
(C=AxB)
(D)
Respondents per year a
(E)
Technical person- hours per year
(E=CxD)
(F)
Management person hours per year
(Ex0.05)
(G)
Clerical person hours per year
(Ex0.1)
(H)
Total Cost
Per year b
1. Attend initial performance test c
32
1
32
0
0.00
0.00
0.00
$0.00
2. Repeat initial performance test








A. Retesting preparation d
12
1
12
0
0.00
0.00
0.00
$0.00
B. Attend retesting e
32
1
32
0
0.00
0.00
0.00
$0.00
3. Litigation f
N/A







4. Excess emissions - enforcement 
 activities g
32
1
32
0.03
0.96
0.048
0.096
$61.44
5. Report review








 Review notification of intent to construct
2
1
2
0
0
0
0
$0.00
 Review notification of anticipated 
 commencement of construction
2
1
2
0
0
0
0
$0.00
 Review notification of anticipated startup
2
1
2
0
0
0
0
$0.00
 Review notification of actual startup
2
1
2
0
0
0
0
$0.00
 Review notification of type(s) of waste 
 to be combusted
2
1
2
0
0
0
0
$0.00
 Review notification of HMIWI capacity
2
1
2
0
0
0
0
$0.00
 Review notification of initial performance test
2
1
2
0
0
0
0
$0.00
 Review notification of initial CMS 
 demonstration
2
1
2
0
0
0
0
$0.00
 Review notification addressing sitting requirements
24
1
24
0
0
0
0
$0.00
 Review waste management plan
8
1
8
0
0
0
0
$0.00
 Review analysis for bag leak detection systems h
8
1
8
0
0
0
0
$0.00
 Review report of initial performance test i
54
1
54
0
0
0
0
$0.00
 Review report of initial CMS demonstration
N/A







 Review annual report








 CMS emissions/operating parameters j
6
1
6
3
18
0.9
1.8
$1,152.06
 Exceedances/malfunctions/periods for which data 
 not obtained k
8
1
8
0.6
4.8
0.24
0.48
$307.22
 Results of performance test conducted 
 during the year l








 PM, CO, HCl
18
1
18
3
54
2.7
5.4
$3,456.19
 Fugitive ash emissions
6
1
6
3
18
0.9
1.8
$1,152.06
 Report of no exceedances m
2
1
2
2.4
4.8
0.24
0.48
$307.22
 Report of annual control equipment
 inspection n
4
1
4
3
12
0.6
1.2
$768.04
 Review semiannual report of exceedances/
 malfunctions/periods for which data not obtained k,o
8
1
8
0.6
4.8
0.24
0.48
$307.22
TOTAL (rounded) p




135
$7,510
Assumptions:








a We have assumed that the average number of sources that will be subject to the standard is 3.
b This cost is based on the average hourly labor rate as follows: Managerial $76.91 (GS-13, Step 5, $48.07 + 60%); Technical $57.07 (GS-12, Step 1, $35.67 + 60%); and Clerical $30.88 (GS-6, Step 3, $19.30+ 60%). This ICR assumes that Managerial hours are 5 percent of Technical hours, and Clerical hours are 10 percent of Technical hours. These rates are from the Office of Personnel Management (OPM), 2024 General Schedule, which excludes locality, rates of pay. The rates have been increased by 60 percent to account for the benefit packages available to government employees.
c We assume EPA personnel attend 8 percent of the initial performance tests.
d We assume that 20 percent will fail the initial performance test, and will have to repeat the performance test.
e We assume 10 percent of initial performance re-tests are attended by EPA personnel.
f This ICR does not account for litigation costs.
g We assume 10 percent of the affected facilities are required to re-test as a result of excess emissions, and that EPA personnel attend 10 percent of these tests.
h We assume only new large and medium sources (i.e. two-thirds of the effected sources) will install baghouses.
i We assume 6 person-hours per report per pollutant. For the three new HMIWI in the three-year period, nine pollutants are required to be tested.
j We assume 1 person-hour per report per CMS. For HMIWI, assume each uses six CMS (flue gas temperature, secondary chamber temperature, charge weight, scrubber liquor pH, scrubber liquor flow, and scrubber energy input).
k We assume 20 percent of the affected facilities with recurrent burden will report monitoring exceedances.
l We assume 6 person-hours per report per pollutant. For annual tests, there are three pollutants (PM, CO, and HCl) for all HMIWI.
m We assume 80 percent of the affected facilities with recurrent burden will report no excess emissions.
n We assume it will take 4 hours to review the annual control equipment inspection report.
o Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods for which data were not obtained, the frequency of semiannual report is shown in the table as only once per year to avoid double-counting.
p Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.


Number of Respondents

Respondents That Submit Reports
Respondents That Do Not Submit Any Reports


(A)
(B)
(C)
(D)
(E)
Year
Number of New Respondents a
Number of Existing Respondents
Number of Existing Respondents that keep records but do not submit reports
Number of Existing Respondents That Are Also New Respondents
Number of Respondents (E=A+B+C-D)
1
0
3
0
0
3
2
0
3
0
0
3
3
0
3
0
0
3
Average
0
3
0
0
3
a New respondents include sources with constructed and reconstructed affected facilities.


Total Annual Responses
(A)
(B)
(C)
(D)
(E)
Information Collection Activity
Number of Respondents
Number of Responses
Number of Existing Respondents That Keep Records But Do Not Submit Reports
Total Annual Responses E=(BxC)+D
Notification of intent to construct
0
1
0
0
Notification of anticipated commencement of construction
0
1
0
0
Notification of anticipated startup
0
1
0
0
Notification of actual startup
0
1
0
0
Notification of type(s) of waste to be combusted
0
1
0
0
Notification of HMIWI capacity
0
1
0
0
Notification of initial performance test
0
1
0
0
Notification of initial CMS demonstration
0
1
0
0
Initial report for the site selection analysis
0
1
0
0
Waste management plan
0
1
0
0
Analysis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection systems1
0
1
0
0
Report of initial performance test
0
1
0
0
Report of initial CMS demonstration
0
1
0
0
Annual reports
CMS emissions and operating parameters
3
1
0
3
Exceedances, malfunctions, and periods for which data not obtained2
0.6
1
0
0.6
Results of performance tests conducted during the year
3
1
0
3
Report of no exceedances2
2.4
1
0
2.4
Report of annual control equipment inspection
3
1
0
3
Semiannual report of exceedances, malfunctions, and periods for which data not obtained2
2.4
2
0
4.8



Total
16.8
1 Assume the total number of sources will be evenly distributed among small, medium, and large sources and only new large and medium sources (i.e. two-thirds of the affected sources) will install baghouses.

2 Assume 20 percent of respondents report monitoring exceedances and 80 percent report no excess emissions.



Capital/Startup vs. Operation and Maintenance (O&M) Costs
(A)
(B)
(C)
(D)
(E)
(F)
(G)
Continuous Monitoring Device
Capital/Startup Cost for One Respondent 1
Number of New Respondents
Total Capital/Startup Cost, (B X C)
Annual O&M Costs for One Respondent 1
Number of Respondents with O&M
Total O&M, 
(E X F)
DIFF/WS2
$1,872
0
$0
$7,188
3
$21,563
DIFF2
$1,469
0
$0
$4,150
3
$12,451
WS2
$1,872
0
$0
$1,721
3
$5,162
SNCR3
$2,126
0
$0
$456
3
$1,367
CO CEMS4
$26,576
0
$0
$38,118
3
$114,355
BLD5
$1,569
0
$0
$1,924
3
$5,772
ACI6
$0
0
$0
$5,113
3
$15,340
Testing7
$102,445
0
$0
$0
3
$0
Filing Cabinets8
$152
0
$0
$0
3
$0
Photocopying8
$0
0
$0
$302
3
$907
Postage8
$0
0
$0
$141
3
$424
Totals (rounded) 9


$0


$177,000
1 Costs have been updated to 2023 dollars using the annual Chemical Engineering Plant Cost Index (CEPCI) values for 2023 and 2007. (Costs = Costs from 2009 final rule x 797.9/525.4).
2 Per the October 6, 2009 final rule (74 FR 51378), assume capital/startup costs of $1,233 and annual operation and maintenance costs of $4,733 per facility for each wet scrubber or dry scrubber with fabric filter followed by wet scrubber, and capital/startup costs of $967 and $2,733 per dry scrubber with fabric filter.
3 Per the October 6, 2009 final rule, assume capital/startup costs of $1,400 and annual operation and maintenance costs of $300 per facility using SCNR for control.
4 Per the October 6, 2009 final rule, assume capital/startup costs of $17,500 and annual operation and maintenance costs of $25,100 per facility using CO CEMS, including daily activities, RATA, CGA, and annual QA and review.
5 Per the October 6, 2009 final rule, assume capital/startup costs of $1,033 and annual operation and maintenance costs of $1,267 per facility using a bag leak detection system.
6 Per the October 6, 2009 final rule, assume annual operation and maintenance costs of $3,367 per facility for lime/carbon flow monitoring.
7 Per the October 6, 2009 final rule, assumes combined initial testing costs of $67,458 per facility.
8 Assumes an initial purchase cost of $100 for filing cabinets, and annual facility costs of $199 for photocopying and $93 for postage.
9 Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.