SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators

(40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal)

1. Identification of the Information Collection

1(a) Title of the Information Collection

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 

CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal), EPA ICR Number 

1899.08, OMB Control Number 2060-0422.

1(b) Short Characterization/Abstract

The State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste 

Incinerators (HMIWI) were proposed on February 27, 1995 (Subpart Ce) and July 6, 1999 

(Subpart HHH), promulgated on September 15, 1997 (Subpart Ce) and August 15, 2000 (Subpart 

HHH), and revised on October 6, 2009, April 4, 2011 and May 13, 2013. 

Subpart Ce requires either states or tribes to develop plans to implement the Emission 

Guidelines. 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. These regulations apply to existing facilities constructed 

before December 1, 2008 or for which modification commenced prior to April 6, 2010 that own 

or operate Hospital/Medical/Infectious Waste Incinerators. 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.

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. All reports are sent to the delegated state or local authority. In 

the event that there is no such delegated authority, the reports are sent directly to the United 

States Environmental Protection Agency (EPA) regional office.
HMIWIs in the United States are owned and operated by either the private sector, the 

Federal government, or state and local governments (the “Affected Public”). The burden to the 

“Affected Public” may be found in Table 1: Annual Respondent Burden and Cost – State and 

Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 

60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal). The burden to the “Federal 

Government” burden is attributed entirely to work performed by either Federal employees or 

government contractors and may be found below in Table 2: Average Annual EPA Burden and 

Cost – State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators 

(40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal).

Based on our consultations with industry representatives, there are an average of 1 

affected facilities at each plant site and that each plant site has only one respondent (i.e., the 

owner/operator of the plant site).

Over the next three years, approximately 58 respondents per year will be subject to the 

standard, and no additional respondents per year will become subject to the standard. There are 

approximately 31 HMIWI, which are owned and operated by the private sector (hospitals, 

commercial waste disposal companies, pharmaceutical companies and private universities); 5

HMIWI are owned and operated by the Federal Government (U.S. military bases, veterans’ 

hospitals and Federal research facilities); none are owned and operated by State or local

governments (state universities). In addition, there are 22 States that require annual State Plan 

Inventory. We assume that they will all respond. This information is based on a 2013 inventory

of HMIWIs. 

The Office of Management and Budget (OMB) approved the currently active ICR 

without any “Terms of Clearance”.

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

The EPA is charged under section 111(d)(1) of the Clean Air Act (CAA), as 

amended, to:

. . . prescribe regulations which shall establish a procedure similar 

to that provided by section 110 under which each State shall 

submit to the Administrator a plan which (A) establishes standards 

of performance for any existing source for any air pollutant (i) for 

which air quality criteria have not been issued or which is not 

included on a list published under section 108(a) . . . but (ii) to 

which a standard of performance under this section would apply if 

such existing source were a new source, and (B) provides for the 

implementation and enforcement of such standards of 

performance.

The EPA is required under section 129 of the Act, to establish guidelines for existing 
stationary sources that reflect the maximum achievable control technology (MACT) for 

achieving continuous emission reductions:

Section 129(a)(1)(A) states:

The Administrator shall establish performance standards and other 

requirements pursuant to section 111 and this section for each 

category of solid waste incineration units. Such standards shall 

include emissions limitations and other requirements applicable to 

new units and guidelines (under section 111(d) and this section) 

and other requirements applicable to existing units.

Section 129(a)(2) states:

Standards applicable to solid waste incineration units promulgated 

under section 111 and this section shall reflect the maximum 

degree of reduction in emissions of air pollutants listed under 

section (a)(4) that the Administrator, taking into consideration the 

cost of achieving such emission reduction, and any non-air quality 

health and environmental impacts and energy requirements, 

determines is achievable for new or existing units in each category.

Section 129(b)(1) states:

Performance standards under this section and section 111 for solid 

waste incineration units shall include guidelines promulgated 

pursuant to section 111(d) and this section applicable to existing 

units. Such guidelines shall include, as provided in this section, 

each of the elements required by subsection (a) (emissions 

limitations, notwithstanding any restriction in section 111(d) 

regarding issuance of such limitations), subsection (c) 

(monitoring), subsection (d) (operator training), subsection (e) 

(permits), and subsection (h)(4) (residual risk).

Subpart B of 40 CFR part 60 requires State plans to include monitoring, recordkeeping, 

and reporting provisions consistent with the emission guidelines. In addition, section 114(a)(1) 

states that:

the Administrator may require any person who owns or operates 

any emission source, who manufactures emission control 

equipment or process equipment, who the Administrator believes 

may have information necessary for the purposes set forth in this 

subsection, or who is subject to any requirement of this Act (other 

than a manufacturer subject to the provisions of section 206(c) or 

208 with respect to a provision of title II) on a one-time, periodic 

or continuous basis to -
4

(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 Administer 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, particulate matter (PM), carbon monoxide (CO), 

dioxin/furans (D/F), hydrogen chloride (HCl), sulfur dioxide (SO2), nitrogen oxide (NOx), lead 

(Pb), cadmium (Cd), and mercury (Hg) emissions from hospital, medical, or infectious waste 

incinerators cause or contribute to air pollution that may reasonably be anticipated to endanger 

public health or welfare. Therefore, the State and Federal Emission Guidelines were promulgated 

for this source category at 40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH.

2(b) Practical Utility/Users of the Data

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 the emission standards. Continuous emission monitors are used to 

ensure compliance with the 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 the standards are used to inform the Agency or delegated 

authority when a source becomes subject to the requirements of the regulations. The reviewing 

authority may then inspect the source to check if the pollution control devices are properly 

installed and operated and leaks are being detected and repaired and the standard(s) are being 

met. The performance test may also be observed.

The required semiannual reports are used to determine periods of excess emissions, 

identify problems at the facility, verify operation/maintenance procedures and for compliance 
5

determinations.

3. Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR Part 60, Subpart

Ce and 40 CFR Part 62, Subpart HHH.

3(a) Nonduplication

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 similar 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, no duplication 

exists.

3(b) Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR was published 

in the Federal Register (80 FR 32116) on June 5, 2015. No comments were received on the 

burden published in the Federal Register. 

3(c) Consultations

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 an Agency

analysis conducted in 2013. 

Industry trade associations 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: 1) the National Waste & Recycling Association 

(NWRA), at (202) 364-3724; and 2) the Larson-Miller Medical Waste Disposal Service, at (801) 

738-6545.

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.

3(d) Effects of Less Frequent Collection
6

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.

3(e) General 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.

3(f) Confidentiality

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).

3(g) Sensitive Questions

The reporting or recordkeeping requirements in the standard do not include sensitive 

questions.

4. The Respondents and the Information Requested

4(a) Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are owners and 

operators of HMIWI for which construction commenced on or before the date of the rule 

proposal. The United States Standard Industrial Classification (SIC) codes and the corresponding 

North American Industry Classification System (NAICS) codes for HMIWI units are provided in 

the following table.
7

Standard (40 CFR Part 60, Subpart Ce and 

40 CFR Part 62, Subpart HHH)

SIC Codes NAICS Codes

General Medical and Surgical Hospitals 806228 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 541712

National Security 9711 928110

Public Health Facility 9431 923120

Nursing and Personal Care Facilities 8051, 8052, 8059 623110, 623311

Veterinary Services 0741, 0742, 8734 541940

4(b) Information Requested

(i) Data Items

In this ICR, all the data that is recorded or reported is required by State and Federal 

Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, 

Subpart Ce and 40 CFR Part 62, Subpart HHH). 

State/US protectorates must perform the following requirements:

Requirement

State Plan to implement and enforce emission guidelines 60.39e(a), 60.23(a)

Notification of public hearing on State Plan 60.23(d)

Certification that public hearing on State Plan conducted according to 

Subpart B State procedures 60.23(f)

Negative Declaration, if applicable 62.06

A source must make the following reports:

Notifications

Installation of CMS 60.37e(e), 60.56c(b)-
8

Notifications

(c), 60.57c, 62.14454

Initial and repeat performance specification tests for CMS 60.37e, 60.56c, 

62.14460(f)

Increments of progress for HMIWI that will comply with regulation 60.39e(c), 

62.14470(b)(2)

Request for extension to shut down late 60.39e(d), 

62.14471(b)

Waste management plan

60.35e, 60.38e(a), 

60.55c, 60.58c(c)(3), 

62.14430

Notification of initial CMS demonstration 60.38e(a), 60.7(a)(5)

Report of initial CMS demonstration 60.38e(a), 60.7(c)

Notification of exemption claim for combustors burning pathological, 

low-level radioactive, and/or chemotherapeutic waste 60.32e(b)

Annual report containing information from annual equipment 

inspection, required maintenance, and repairs not completed during 

established time frame

60.38e(b)(2), 

62.14463(a)(12)-(13)

Notification of exemption claim for co-fired combustors 60.32e(c)(1)

Notification of relative weight of hospital waste, medical/infectious 

waste, and other fuels and/or waste to be combusted at co-fired 

combustor

60.32e(c)(2)

Notification of initial performance test (PM, CO, fugitive emissions, 

stack opacity, dioxins/furans, HCI, Cd, Pb, Hg) 60.38e(a), 60.8(d)

Report of initial performance test 

60.38e(a), 60.58c(c), 

60.8 (a), 

60.58c(d)(6), 

62.14470(b)(4) 

62.14463(a)(1), 

62.14464(a)

Initial report of values for site-specific operating parameters

60.38e(a), 

60.58c(c)(2), 

62.14463(a)(2), 

62.14463(a)(4), 

62.14464(a)

Annual report of values for site-specific operating parameters

60.38e(a), 

60.58c(d)(1), 

62.14463(a)(7) – (8),
9

Notifications

62.14464(b)

Annual report of the highest maximum and lowest minimum 

operating parameters 

60.38e(a),

60.58c(d)(2) – (3), 

62.14463(a)(5) – (6),

62.14464(b)

Annual and semiannual reports of emissions or operating parameter 

exceedances, malfunctions, and periods for which data on 

emissions/operating parameters were not obtained 

60.38e(a), 60.58c(d) 

– (e), 60.7(c) – (d), 

62.14463(a)(7)-(8), 

62.14464(b) – (c)

Annual report containing results of annual performance test

60.38e(a) – (b), 

60.58c(d), 

62.14463(a)(9), 

62.14464(b)

Annual report of no excess emissions, malfunctions, or operating 

parameter exceedances 

60.38e(a), 

60.58c(d)(7), 60.7(c), 

62.14463(a)(10),

62.14464(b)

Results of previous performance tests 60.38e(a)

Any use of the bypass stack, duration, reason for malfunction, and 

corrective action taken

60.38e(a), 

60.58c(d)(8), 

62.14463(a)(11)

Concentrations of CO, PM, HCl, Pb, Cd, Hg and dioxin/furan, as 

applicable, as determined by the CEMS or continuous automated 

sampling system, as applicable

62.14463(a)(14)

Petition for site-specific operating parameters for control device not 

listed, if applicable 62.14463(a)(15)

Annual update of operating information 60.34e, 60.53c(h) –

(i), 62.14423(c)

Annual review of operating information with each operator 60.34e, 60.53c(h) –

(i), 6214425(a)

A source must keep the following records:

Recordkeeping

Records of public hearing conducted on State Plan 60.23(e)

Retention of records for 5 years 60.38e(a), 

60.58c(b), 60.58c(f), 
10

Recordkeeping

62.14461

Records of startup, shutdown, or malfunction 60.38e(a), 60.58c, 

60.7(b), 62.14460(d)

Records of initial performance test 60.37e, 60.56c, 

62.14460(a) & (f)

Records of CMS operation and maintenance 60.38e(a), 60.58c, 

60.7(f), 62.14460(a)

Records of annual equipment inspections, required maintenance, and 

repairs not completed during established timeframe

60.38e(b), 

62.14460(a) & 

(b)(14)

Records on a quarterly basis of periods, when only pathological, lowlevel radioactive, and/or chemotherapeutical waste is burned. 60.32e(b) 62.14400

Records of quarterly basis of weight of hospital waste and 

medical/infectious waste combusted, and weight of all other fuels and 

waste combusted at co-fired combustors

60.32e(c), 62.14400

Records for which data on emissions/operating parameters were not 

obtained

60.38e(a), 

60.58c(b), 60.8(f), 

62.14460(c) – (e)

Records related to malfunctions

60.38e(a), 

60.58c(b), 60.8(f), 

62.14460(d)

Records of emissions or operating parameter exceedances

60.38e(a), 

60.58c(b), 60.8(f), 

62.14460(e)

Records of initial, annual, and any subsequent performance tests

60.38e(a), 

60.58c(b), 60.8(f), 

62.14460(f)

Records of persons completing reviews of HMIWI operating manual 

(initial and annual)

60.38e(a), 60.53c(j), 

60.58c(b), 

62.14460(g)

Records of operators completing operator training course and 

qualification requirements

60.38e(a), 60.53c(j), 

60.58c(b), 

62.14460(h)

Records of operators who have met the qualification requirements

60.38e(a), 60.53c(j), 

60.58c(b), 

62.14460(h) – (i)

Records of calibration of any monitoring devices 60.38e(a), 

60.58c(b), 
11

Recordkeeping

62.14460(j)

Records of emissions, process, and control device operating parameters

60.38e(a), 

60.58c(b), 60.8(f), 

62.14460(a) and 

(b)(2-13)

Records of initial testing of fugitive ash emissions 60.38e(a), 

60.58c(b)(2)(ii)

Electronic Reporting

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. If the respondent chooses to submit an electronic copy of stack test reports to the 

EPA's WebFIRE database, as of December 31, 2011, they must enter the test data into the EPA's 

database using the Electronic Reporting Tool (ERT) located at 

http://www.epa.gov/ttn/chief/ert/ert_tool.html.

(ii) Respondent Activities

Respondent Activities

Familiarization with the regulatory requirements.

Develop State Plan and inventory and update inventory annually. 

Conduct public hearing on State Plan. 

Install, calibrate, maintain, and operate CMS for opacity, or for pressure drop and liquid 

supply pressure for control device.

Perform CMS demonstrations and repeat CMS demonstrations if necessary.

Perform initial performance tests and repeat performance tests if necessary.

Develop, update, and review operating information. 

Perform inspections. 

Write the notifications and reports listed above.

Develop waste management plan.
12

Respondent Activities

Prepare and review reports of performance tests and CMS demonstrations.

Submit the required reports developing, acquiring, installing, and utilizing technology and 

systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and 

maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and 

providing information.

Complete operator training and qualification.

Train personnel to be able to respond to a collection of information.

Maintain the records listed in the table above.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information 

Management

5(a) Agency Activities

EPA conducts the following activities in connection with the acquisition, analysis, 

storage, and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests if necessary. 

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 Online Tracking Information System (OTIS). 

5(b) Collection Methodology and Management

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 
13

emission standard. 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. ICIS is 

EPA’s database for the collection, maintenance, and retrieval of compliance data for industrial 

and government-owned facilities. 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.

The records required by this regulation must be retained by the owner/operator for five 

years.

5(c) Small Entity Flexibility

A majority of the respondents are large entities (i.e., large businesses). However, the 

impact on small entities (i.e., small businesses) was taken into consideration during the 

development of the 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. However, the regulation includes various provisions that would reduce the burden on 

HMIWI, including the two HMIWI within the respondent universe that are classified as small 

entities. For example, there are provisions allowing HMIWI to skip annual tests and test reports 

for 2-year periods if they have demonstrated compliance for three annual tests in a row. Also, the 

emission guidelines allow HMIWI to submit previous emission tests to demonstrate compliance 

with the emission limits in the revised guidelines. To the extent that larger businesses can use 

economies of scale to reduce their burden, the overall burden will be reduced.

5(d) Collection Schedule

The specific frequency for each information collection activity within this request is 

shown in below Table 1: Annual Respondent Burden and Cost – State and Federal Emission 

Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 

40 CFR Part 62, Subpart HHH) (Renewal).

6. Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the recordkeeping and 

reporting requirements applicable to the industry for each of the subparts 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.
14

The Agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a currently valid OMB Control Number.

6(a) Estimating Respondent Burden

The average annual burden to industry over the next three years from these recordkeeping 

and reporting requirements is estimated to be 38,800 (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 Emission Guidelines program, the 

previously approved ICR, and any comments received.

6(b) Estimating Respondent Costs

(i) Estimating Labor Costs

This ICR uses the following labor rates: 

Managerial $129.93 ($61.87+ 110%)

Technical $103.97 ($49.51 + 110%)

Clerical $51.79 ($24.66 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, June 

2014, “Table 2. Civilian Workers, by occupational and industry group.” The rates are from 

column 1, “Total compensation.” The rates have been increased by 110 percent to account for 

the benefit packages available to those employed by private industry.

(ii) Estimating Capital/Startup and Operation and Maintenance Costs

The type of industry costs associated with the information collection activities in the 

subject standards 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 the regulation. The annual operation and maintenance costs are the 

ongoing costs to maintain the monitors and other costs such as photocopying and postage.

(iii) Capital/Startup vs. Operation and Maintenance (O&M) Costs
15

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring 

Device

(B)

Capital/Startup 

Cost for One 

Respondent

(C)

Number of 

New

Respondents

(D)

Total 

Capital/Startup 

Cost, (B X C)

(E)

Annual O&M 

Costs for One 

Respondent 

(F)

Number of 

Respondents

with O&M

(G)

Total O&M,

(E X F)

Monitoring costs 

- Privately-owned 

HMIWI $3,751 0 $0 $11,957 31 $370,667

- Federally owned 

HMIWI $3,700 0 $0 $8,317 5 $41,585

- State/locally-owned 

HMIWI $3,700 0 $0 $6,275 0 $0

Testing1$21,000 0 $0 NA 0 $0

File Cabinets2$33.50 0 $0 NA 0 $0

Photocopying and postage

- States N/A 0 $0 $16.27 22 $357.94

- Privately-owned 

HMIWI N/A 0 $0 $50.28 31 $1,558.68

- Federally owned 

HMIWI N/A 0 $0 $49.67 5 $248.35

- State/locally-owned 

HMIWI N/A 0 $0 $49.50 0 $0

Temperature pressure, flow rate, change rate, voltage, and pH monitors3

- Privately-owned 

HMIWI N/A 0 $0 $1,800 31 $55,800

- Federally owned 

HMIWI N/A 0 $0 $1,800 5 $9,000

- State/locally-owned 

HMIWI N/A 0 $0 $1,800 0 $0

Subtotals

- States $0 $358

- Privately-owned 

HMIWI $0 $428,025

- Federally owned 

HMIWI $0 $50,833

- State/locally-owned 

HMIWI $0 $0

TOTAL $0 $479,000

Notes: Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding. This ICR 

assumes that all existing respondents have already installed monitoring and testing equipment to comply with the 

emission guidelines, including equipment for in-house testing of fugitive ash emissions required by the revised 

emission guidelines. Therefore, there is no capital/startup costs associated with this ICR.

1 Average testing cost for all respondents

2 Annualized cost with a capital recovery factor of 0.14238 based on a 10-year equipment life and a 7 percent 
16

interest rate, assuming each facility will purchase one standard four-drawer file cabinet ($235 per cabinet). 

3 The average HMIWI operates approximately 6 continuous monitoring devices. The average cost per monitoring 

device is $300 per year. Therefore, the estimated O&M cost per respondent is estimated to be $1,800.

The total capital/startup costs for this ICR are $0. This is the total of column D in the 

above table. 

The total operation and maintenance (O&M) costs for this ICR are $479,000. This is the 

total of column G. 

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 $479,000. These are 

recordkeeping costs.

6(c) Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of the reported 

information. EPA's overall compliance and enforcement program includes activities such 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 cost during the three years of the ICR is estimated to be 

$87,000.

This cost is based on the average hourly labor rate as follows:

Managerial $62.90 (GS-13, Step 5, $39.31 + 60%) 

Technical $46.67 (GS-12, Step 1, $29.17 + 60%)

Clerical $25.25 (GS-6, Step 3, $15.78 + 60%)

These rates are from the Office of Personnel Management (OPM), 2014 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 below in Table 2: Average Annual EPA Burden and Cost – State and 

Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 

60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal).

6(d) Estimating the Respondent Universe and Total Burden and Costs

Based on our research for this ICR, on average over the next three years, approximately

58 existing respondents (31 privately-owned, 5 Federally-owned, and no State/locally-owned, 

plus the 22 states requiring State Plan Inventories) will be subject to the standard. It is estimated 

that no additional respondents per year will become subject. The overall average number of 

respondents, as shown in the table below, is 58 per year.
17

The number of respondents is calculated using the following table that addresses the three 

years covered by this ICR.

Number of Respondents

Respondents That Submit Reports Respondents That Do 

Not Submit Any Reports

Year

(A)

Number of New 

Respondents 1

(B)

Number of 

Existing 

Respondents

(C)

Number of Existing

Respondents that keep 

records but do not 

submit reports

(D)

Number of 

Existing 

Respondents That 

Are Also New

Respondents

(E)

Number of 

Respondents

(E=A+B+C-D)

1 0 58 0 0 58

2 0 58 0 0 58

3 0 58 0 0 58

Average 0 58 0 0 58

1

New respondents include sources with constructed, reconstructed and modified affected facilities.

Column D is subtracted to avoid double-counting respondents. As shown above, the 

average Number of Respondents over the three year period of this ICR is 58. 

The total number of annual responses per year is calculated using the following table: 
18

(A)

Information Collection Activity

States

PrivatelyOwned 

HMIWI

FederallyOwned 

HMIWI

State/Locally 

Owned 

HMIWI

Total

State Plan/inventory10 0 0 0 0

Annual update of State Plan 

inventory 22 0 0 0 22

Notification of initial performance 

test and CMS demonstration N/A

Annual Reports2

CMS emissions and operating 

parameters 0 31 5 0 36

Exceedances, malfunctions, and 

periods for which data not 

obtained

0 6.2 1 0 7.2

Results of performance tests 

conducted during the year 0 31 5 0 36

Report of no exceedances 0 24.8 4 0 28.8

Report of annual equipment 

inspection (small rural HMIWI) 0 1 0 0 1

Semiannual report of exceedances, 

malfunctions, and periods for which 

data not obtained3

0 6.2 1 0 7.2

Total422 100 16 0 138

1 This ICR assumes all 22 states have approved State Plans by the first year this ICR.

2 This ICR assumes 20% of respondents report exceedances, and 80% of respondents report no exceedances.

3 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. 

4 Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

The number of Total Annual Responses is 138 (22 for States, 100 for privately owned 

HMIWI, 16 for federally owned HMIWI and 0 for State/locally owned HMIWI).

The total annual labor costs are $3,890,000. Details regarding these estimates may be 

found below in Table 1: Annual Respondent Burden and Cost – State and Federal Emission 

Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 

40 CFR Part 62, Subpart HHH) (Renewal).

6(e) Bottom Line Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the respondents and the 

Agency are shown in Tables 1 and 2 below, respectively, and summarized below.
19

(i) Respondent Tally

The total annual labor hours are 38,800. Details regarding these estimates may be found 

in Table 1. Annual Respondent Burden and Cost – State and Federal Emission Guidelines for 

Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 

62, Subpart HHH) (Renewal).

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.

Furthermore, the annual public reporting and recordkeeping burden for this collection of 

information is estimated to average 281 hours per response.

The total annual capital/startup and O&M costs to the regulated entity are $479,000. The 

cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance 

(O&M) Costs.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is estimated to be 

1,920 labor hours at a cost of $87,000. See Table 2: Average Annual EPA Burden and Cost –

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 

CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal).

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.

6(f) Reasons for Change in Burden

There is an overall decrease in the respondent and Agency burden currently identified in 

the OMB Inventory of Approved Burdens due to a decrease in the respondent universe since the 

previous ICR. Based on the 2013 Agency analysis, 21 HMIWI units (16 privately owned, 1 

federally owned, and 4 state owned) have been shut down over the past several years. The 

revised estimate results in a decreased in respondent labor hours, number of responses, and 

capital/O&M costs. 

However, there is a slight adjustment increase in respondent hours for States due to a 

change in assumption. In this ICR, we assume all respondents will take some time to refamiliarize themselves with the regulatory requirements. 

6(g) Burden Statement
20

The annual public reporting and recordkeeping burden for this collection of information 

is estimated to average 281 hours per response. Burden means the total time, effort, or financial 

resources expended by persons to generate, maintain, retain, or disclose or provide information 

to or for a Federal agency. This includes the time needed to review instructions; develop, 

acquire, install, and utilize technology and systems for the purposes of collecting, validating, and 

verifying information, processing and maintaining information, and disclosing and providing 

information; adjust the existing ways to comply with any previously applicable instructions and 

requirements; train personnel to be able to respond to a collection of information; search data 

sources; complete and review the collection of information; and transmit or otherwise disclose 

the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a valid OMB Control Number. The OMB Control 

Numbers for EPA regulations are listed at 40 CFR Part 9 and 48 CFR Chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided 

burden estimates, and any suggested methods for minimizing respondent burden, including the 

use of automated collection techniques, EPA has established a public docket for this ICR under 

Docket ID Number EPA-HQ-OECA-2011-0272. An electronic version of the public docket is 

available at http://www.regulations.gov/ which may be used to obtain a copy of the draft 

collection of information, submit or view public comments, access the index listing of the 

contents of the docket, and to access those documents in the public docket that are available 

electronically. When in the system, select “search,” then key in the docket ID number identified 

in this document. The documents are also available for public viewing at the Enforcement and 

Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, 

Room 3334, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public 

Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 

holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone 

number for the docket center is (202) 566-1927. Also, you can send comments to the Office of 

Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, 

Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID 

Number EPA-HQ-OECA-2011-0272 and OMB Control Number 2060-0422 in any

correspondence. 

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this 

information.
21

Table 1: Annual Respondent Burden and Cost – State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste 

Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (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 

personhours per 

year 

(E=CxD)

(F) 

Manage

ment 

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 (States)

 A. Familiarize with Regulatory Requirements c1 1 1 22 22 1.1 2.2 $2,537.60 

 B. Required activities d

- Development of State Plan/Inventory 2,080 1 2,080 0 0 0 0 $0 

- Annual update of State Plan Inventory 20 1 20 22 440 22 44 $50,752.02 

- Public hearing on State Plan 8 1 8 0 0 0 0 $0 

 C. Create information See 3B

 D. Gather information See 3B

 E. Write report

- State Plan/Inventory See 3B

- Annual update of State Plan Inventory See 3B

- Notification of public hearing on State Plan 8 1 8 0 0 0 0 $0 

- Certification that public hearing on State Plan 

conducted according to Subpart B State procedures 2 1 2 0 0 0 0 $0 

Subtotal for Reporting Requirements (States) 531 $53,290 

4. Reporting requirements (privately-owned HMIWI)

 A. Familiarize with Regulatory Requirements c1 1 1 31 31 1.55 3.1 $3,575.71 

 B. Required activities e

 Installation of CMS 15 1 15 0 0 0 0 $0 

 Performance specification tests for CMS 8 1 8 0 0 0 0 $0 
22

 Repeat performance specification tests/CMS 8180000 $0 

 Initial equipment inspection (small rural HMIWI) 201 200000 $0 

 Annual update of operating information

f

201 20 31 620 31 62 $71,514.21 

 Review operating information with each operator 

g

82 16 31 496 24.8 49.6 $57,211.37 

 Annual equipment inspection (small rural HMIWI) 201 201 2012 $2,306.91 

 Annual equipment inspection (all other HMIWI) 201 20 30 600 30 60 $69,207.30 

 C. Create information See 4B

 Development of operating information 

h

1601 1600000 $0 

 D. Gather information See 4B

 E. Write report 

e

 Increments of progress for HMIWI that will Comply

 Control plan 241 240000 $0 

 Notification of construction contracts 2120000 $0 

 Notification of construction commencement 2120000 $0 

 Notification of construction completion2120000 $0 

 Notification of control plan completion 2120000 $0 

 Request for extension to shut down date 121 120000 $0 

 Notification of initial performance test 2120000 $0 

 Notification of initial CMS demonstration 2120000 $0 

 Waste management plan

i

1601 1600000 $0 

 Report of initial performance test for PM, CO, Hg, 

dioxins/furans, and stack opacity (small rural HMIWI) 560

1 5600000 $0 

 Report of initial performance test for PM, CO, HCI, 

dioxins/furans, metals, and stack opacity (small non-rural, 

medium, and large HMIWI) 

6401 6400000 $0 

 Report of initial CMS demonstration See 4B

 Annual report 

 CMS operating parameters 321 32 31 992 49.6 99.2 $114,422.74 

 Emissions/parameter exceedances and periods when 

emission/parameter data not obtained

j

- Small rural HMIWI 161 16 0.2 3.2 0.16 0.32 $369.11 
23

- All other HMIWI 641 646 384 19.2 38.4 $44,292.67 

 Report of annual performance test - Small rural HMIWI 20

1 201 2012 $2,306.91 

- All other HMIWI 2801 280 30 8,400 420 840 $968,902.20 

 Report of no exceedances - Small rural HMIWI

818 0.8 6.4 0.32 0.64 $738.21 

- All other HMIWI 321 32 24 768 38.4 76.8 $88,585.34 

 Report of annual equipment inspection See 4B

 Semiannual report of emissions/parameter exceedances and 

periods when emission/parameter data not obtained (small non-

rural, medium, and large HMIWI) 

j

322 646 384 19.2 38.4 $44,292.67 

 Semiannual report of emissions/parameter exceedances and 

periods when emission/parameter data not obtained (small rural 

HMIWI) 

j

82 16 0.2 3.2 0.16 0.32 $369.11 

Subtotal for Reporting Requirements (Privately-owned 

HMIWI) 14,637 $1,468,094 

5. Reporting requirements (Federally-owned HMIWI)

 A. Familiarize with Regulatory Requirements 

c

11155 0.25 0.5 $576.73 

 B. Required activities

 Annual update of operating information

f

201 205 1005 10 $11,534.55 

 Review operating information with each operator 

g

82 165 8048 $9,227.64 

 Annual control equipment inspection 201 205 1005 10 $11,534.55 

 C. Create information NA

 D. Gather existing information See 5B

 E. Write report

 Annual report 

 CMS operating parameters 321 325 1608 16 $18,455.28 

 Emissions/parameter exceedances and periods when 

emission/parameter data not obtained

j 64

1 641 64 3.2 6.4 $7,382.11 

 Report of annual performance test 401 405 200 10 20 $23,069.10 

 Report of no exceedances 321 324 128 6.4 12.8 $14,764.22 

 Report of annual equipment inspection See 5B
24

 Semiannual report of emissions/parameter exceedances and 

periods when emission/parameter data not obtained

j 32

2 641 64 3.2 6.4 $7,382.11 

Subtotal for Reporting Requirements (Federally-owned 

HMIWI) 1,03

6 $103,926

6. Reporting requirements (State/locally-owned HMIWI)

 A. Familiarize with Regulatory Requirements 

c

1110000 $0 

 B. Required activities

 Annual update of operating information 201 200000 $0 

 Review operating information with each operator 82 160000 $0

 Annual control equipment inspection 201 200000 $0

 C. Create information NA

 D. Gather existing information See 6B

 E. Write report

 Annual report 

 CMS operating parameters 321 320000 $0

 Emissions/parameter exceedances and periods when 

emission/parameter data not obtained

j 64

1 640000 $0

 Report of annual performance test 401 400000 $0

 Report of no exceedances 

j

321 320000 $0

 Report of annual equipment inspection See 6B

 Semiannual report of emissions/parameter exceedances and 

periods when emission/parameter data not obtained

j 32

2 640000 $0

Subtotal for Reporting Requirements (State/locally-owned 

HMIWI)

0 $0 

7. Reporting requirements (co-fired combustors and 

pathological/low-level radioactive/chemotherapeutic waste 

combustors)

 A. Familiarize with Regulatory Requirements 

c

111 13.4 13.4 0.67 1.34 $1,546 

 B. Required activities N/A

 C. Create information N/A

 D. Gather existing information N/A

 E. Write report

 Notification of exemption claim 2120000 $0 
25

 Notification of relative amounts of hospital waste, 

medical/infectious waste, and other fuels and wastes to be 

combusted (co-fired combustors only) 

2 1 2 0 0 0 0 $0 

Subtotal for Reporting Requirements (Co-fired combustors 

and pathological/low-level radioactive/chemotherapeutic 

waste combustors)

15 $1,546 

8. Recordkeeping requirements (States)

 A. Familiarize with Regulatory Requirements See 3A

 B. Plan activities NA

 C. Implement activities NA

 D. Develop record system NA

 E. Time to enter information NA

 F. Time to train personnel NA

 G. Time for audits NA

Subtotal for Recordkeeping Requirements (States) 0 $0 

9. Recordkeeping requirements (privately-owned HMIWI)

 A. Familiarize with Regulatory Requirements See 4A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A

 E. Time to enter information

 Records of startup, shutdown, malfunction 1.5 52 78 31 2,418 120.9 241.8 $278,905.42 

 Records of persons reviewing operating information 2 2 4 31 124 6.2 12.4 $14,302.84 

 Records of operators completing training requirements 2 1 2 0 0 0 0 $0 

 Records of operators that have been qualified 2 1 2 0 0 0 0 $0 

 Records of initial performance test See 4E

 Records of process and control device operating parameters

- Small rural HMIWI 0.5 52 26 1 26 1.3 2.6 $2,998.98 

- All other HMIWI 1.5 52 78 30 2,340 117.0 234 $269,908.47 

 Records of CMS operation and maintenance

- Small rural HMIWI 0.5 250 125 1 125 6.25 12.5 $14,418.19 
26

- All other HMIWI 1.5 250 375 30 11,250 562.5 1,125.0 $1,297,636.88 

 Records of emissions/parameter exceedances and periods 

when emission/parameter data not obtained j

- Small rural HMIWI 0.5 52 26 0.2 5.2 0.26 0.52 $599.80 

- All other HMIWI 1.5 52 78 6 468 23.4 46.8 $53,981.69 

 Records of annual and subsequent compliance tests See 4E

 Records of annual equipment inspection See 4B

 F. Time to train personnel 40 1 40 0 0 0 0 $0 

 G. Time for audits N/A

Subtotal for Recordkeeping Requirements (Privately-owned 

HMIWI) 19,270 $1,932,752 

10. Recordkeeping requirements (Federally-owned HMIWI)

 A. Familiarize with Regulatory Requirements See 5A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A

 E. Time to enter information

 Records of startup, shutdown, malfunction 1.5 52 78 5 390 19.5 39 $44,984.75 

 Records of persons reviewing operating information 2 2 4 5 20 1 2 $2,306.91 

 Records of operators completing training requirements 2 1 2 0 0 0 0 $0 

 Records of operators that have been qualified 2 1 2 0 0 0 0 $0 

 Records of initial performance test See 5E

 Records of process and control device operating parameters 1.5 52 78 5 390 19.5 39 $44,984.75 

 Records of CMS operation and maintenance 1.5 250 375 5 1,875 93.75 187.5 $216,272.81 

 Records of emissions/parameter exceedances and periods 

when emission/parameter data not obtained j 1.5 52 78 1 78 3.9 7.8 $8,996.95 

 Records of annual and subsequent compliance tests See 5E

 Records of annual equipment inspection See 5B

 F. Time to train personnel 40 1 40 0 0 0 0 $0 

 G. Time for audits N/A
27

Subtotal for Recordkeeping Requirements (Federally-owned 

HMIWI) 3,166 $317,546 

11. Recordkeeping requirements (State/locally-owned 

HMIWI)

 A. Familiarize with Regulatory Requirements See 6A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A

 E. Time to enter information

 Records of startup, shutdown, malfunction 1.5 52 780000 $0

 Records of persons reviewing operating information r2240000 $0

 Records of operators completing training requirements2120000 $0 

 Records of operators that have been qualified2120000 $0 

 Records of initial performance test See 6E

 Records of process and control device operating parameters 1.5 52 780000 $0

 Records of CMS operation and maintenance 1.5 250 3750000 $0

 Records of emissions/parameter exceedances and periods 

when emission/parameter data not obtained 

j 1.5 52 78

0000 $0

 Records of annual and subsequent compliance tests See 6E

 Records of annual equipment inspection See 6B

 F. Time to train personnel 401 400000 $0 

 G. Time for audits N/A

Subtotal for Recordkeeping Requirements (State/Locally-

owned HMIWI)

0 $0 

12. Recordkeeping requirements (co-fired and 

pathological/low-level radioactive/ chemotherapeutic 

combustors) 

 A. Familiarize with Regulatory Requirements See 7A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A

 E. Time to enter information
28

 Quarterly records of periods when only pathological, lowlevel radioactive, chemotherapeutic waste burned k 2 4 8 13.4 107.2 5.36 10.72 $12,365.04 

 Quarterly records of weight of hospital waste and 

medical/infectious waste combusted, and weight of all other 

fuels and waste combusted (co-fired only) k

2 4 8 5 40 2 4 $4,613.82 

 F. Time to train personnel N/A

 G. Time for audits N/A

Subtotal for Recordkeeping Requirements (Co-fired and 

pathological/low level radioactive / chemotherapeutic 

combustors)

169 $16,979 

TOTAL REPORTING REQUIREMENTS (FROM 

SUBTOTALS) 16,220 $1,626,856

TOTAL RECORDKEEPING REQUIREMENTS (FROM 

SUBTOTALS) 22,605 $2,267,277 

TOTAL LABOR BURDEN AND COST (ROUNDED) l38,800 $3,890,000 

TOTAL CAPITAL AND O&M COST (ROUNDED) l$479,000 

GRAND TOTAL (ROUNDED) l$4,370,000 

Note: States and tribes may choose to impose requirements that are more stringent. However, the burden estimates provided in this ICR assume that the state and 

tribal plans mirror the federal Emission Guidelines.

Assumptions:

a We have assumed that there are approximately 58 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three 

years. The breakdown is as follows: 31 privately-owned HMIWI (including 1 small rural HMIWI), 5 Federally-owned HMIWI, and 0 State/locally-owned 

HMIWI, and 22 States that require annual State Plan Inventory.

b This ICR uses the following labor rates for industry: $129.93 per hour for Executive, Administrative, and Managerial labor; $103.97 per hour for Technical 

labor, and $51.79 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, June 2014 “Table 2. Civilian 

Workers, by Occupational and Industry group.” The rates are from column 1, “Total Compensation.” The rates have been increased by 110 percent to account for 

the benefit packages available to those employed by private industry. In addition, this ICR uses the following labor rates for State government: $65.41 for 

Managerial labor; $52.43 for Technical labor, and $24.88 for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor 

Statistics, May 2013 National Industry-Specifics Occupational Employment and Wage Estimates for State government (NAICS code 999200). The rates have 

been increased by 60 percent to account for the benefit packages available to State government employees. 

c We have assumed all respondents will have to familiarize with regulatory requirements

d Assume all 22 states with HMIWI have approved State Plan by the first year of this ICR. However, the State Plan/Inventory is updated on an annual basis. 

e The zero value for number of respondents indicates that burden was incurred prior to the time period covered by this supporting statement or for new

respondents.

f We have assumed that it would take each respondent 20 hours each to update the annual operating information.

g We have assumed that it would take each respondent 8 hours to review the operating information with each operator.
29

h We have assumed that each facility will take 160 hours to develop the operating information.

i We have assumed that each facility will rake 40 hours to develop the waste management plan.

j Assume 20 percent of respondents report exceedances, and 80 percent report no exceedances.

k We have assumed that all co-fired and pathological/low-level radioactive/ chemotherapeutic combustors units would be owned by the private sector.

l Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding
30

Table 2: Average Annual EPA Burden and Cost – State and Federal Emission Guidelines for Hospital/Medical/Infectious 

Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (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 

personhours 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. Initial performance test 32 1 32 0 0 0 0 $0 

2. Repeat performance test

 A. Retesting preparation 12 1 12 0 0 0 0 $0 

 B. Attend retesting 32 1 32 0 0 0 0 $0 

3. Report review

 A. Review reports for co-fired combustors

 Review notification of exemption claim 2 1 2 0 0 0 0 $0 

 Review notification of relative amounts of hospital 

waste, medical/infectious waste, and other fuels and wastes to 

be combusted

2 1 2 0 0 0 0 $0 

 B. Review notification of exemption claim for 

pathological, low-level radioactive, chemotherapeutic 

combustors

2 1 2 0 0 0 0 $0 

 C. Review reports of increments of progress

 Review control plan 4 1 4 0 0 0 0 $0 

 Review notification of construction contracts 2 1 2 0 0 0 0 $0 

 Review notification of construction commencement 2 1 2 0 0 0 0 $0 

 Review notification of construction completion 2 1 2 0 0 0 0 $0 

 Review notification of control plan completion 2 1 2 0 0 0 0 $0 

 D. Review request for extension for HMIWI planning to 

shut down late 4 1 4 0 0 0 0 $0 

 E. Review reports for small non-rural, medium and large 

HMIWI

 Review waste management plan 8 1 8 0 0 0 0 $0 
31

 Review notification of initial performance test 8180000 $0 

 Review notification of initial CMS demonstration5150000 $0 

 Review report of initial performance test 361 360000 $0 

 Review report of initial CMS demonstration 241 240000 $0 

 Review annual report

 CMS operating parameters - Small rural HMIWI

21212 0.1 0.2 $104.68 

- All other HMIWI616 35 210 10.5 21 $10,991.40 

Emissions/parameter exceedances and periods when 

emission/parameter data not obtained 

c

- Small rural HMIWI414 0.2 0.8 0.04 0.08 $41.87 

- All other HMIWI 161 167 112 5.6 11.2 $5,862.08 

 Results of annual performance test - Small rural HMIWI

61616 0.3 0.6 $314.04 

- All other HMIWI 241 24 35 840 42 84 $43,965.60 

 Report of no exceedances - Small rural HMIWI

212 0.8 1.6 0.08 0.16 $83.74 

- All other HMIWI818 28 224 11.2 22.4 $11,724.16 

 Review semiannual report of emissions/ parameter 

exceedances and periods when emission/parameter data not 

obtained 

c

- Small rural HMIWI212 0.2 0.4 0.02 0.04 $20.94 

- All other HMIWI8187 56 2.8 5.6 $2,931.04 

 Report of annual equipment inspection (Small rural 

HMIWI)

41414 0.2 0.4 $209.36 

 Report of annual control equipment inspection (All 

other HMIWI)

4140000 $0 

 G. Review reports for States

 Review annual update of State Plan Inventory 

d

818 22 176 8.8 17.6 $9,211.84 

4. Prepare annual summary report 

e

111 36 36 1.8 3.6 $1,884.24 
32

TOTAL ANNUAL BURDEN AND COST (ROUNDED) f1,920 $87,000 

Assumptions:

a We have assumed that there are approximately 36 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three 

years. The 36 respondents are located in 22 States.

b This cost is based on the following hourly labor rates times a 1.6 benefits multiplication factor to account for government overhead expenses: $62.90 for 

Managerial (GS-13, Step 5, $39.31 x 1.6), $46.67 for Technical (GS-12, Step 1, $29.17 x 1.6) and $25.25 Clerical (GS-6, Step 3, $15.78 x 1.6). These rates are 

from the Office of Personnel Management (OPM) “2014 General Schedule” which excludes locality rates of pay.

c Assume 20 percent of respondents report parameter exceedances, and 80 percent report no exceedances.

d Assume all 22 States have approved State/Plan Inventory by the first year of this ICR. All States are expected to update State Plan/Inventory annually. 

e We have assumed that all respondents will have to prepare annual summary report.

f Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding