SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

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

(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 

1899.07, OMB Control Number 2060-0422

1(b) Short Characterization/Abstract

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

Incinerators were promulgated on September 15, 1997 (subpart Ce) and September 14, 2000

(subpart HHH), and revised on October 6, 2009. 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. 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 Emission Guidelines. This information is being 

collected to assure compliance with 40 CFR part 60, subpart Ce and 40 CFR part 62, Subpart 

HHH.

In general, the 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 U.S. 

Environmental Protection Agency (EPA) regional office.

Over the next three years, an average of 79 existing sources located at 73 different 

facilities will be subject to the standard and no additional respondents per year will become 

subject to the standard. An estimated 47 of these sources are owned and operated by the private 

sector (hospitals, commercial waste disposal companies, pharmaceutical companies, and private 

universities); 6 are owned and operated by the Federal government (U.S. military base, veterans 

hospitals, and Federal research facilities); and 4 are owned and operated by State or local 
governments (State universities), and 22 States that require annual State Plan Inventory. 

This ICR 1899.07 is being combined with ICR number 2335.02, (OMB control number 

2060-0628). The number of existing sources is increased from 57 to 79; the latter number 

includes 22 States who must report their annual update of State Plan Inventory.

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

without any “Terms of Clearance.” 

Hospital/Medical/Infectious Waste Incinerators (HMIWI) 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 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). 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).

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 -

(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 
4

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 where 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, leaks are being detected and repaired, and the standards 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 

determinations.

3. Non-duplication, 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.
5

3(a) Non-duplication

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, 

duplication does not exist.

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 (76 FR 26900) on May 9, 2011. 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 Online Tracking Information System (OTIS) which is operated 

and maintained by EPA's Office of Compliance. OTIS is EPA’s database for the collection, 

maintenance, and retrieval of all compliance data. The growth rate for the industry is based on 

our consultations with the Agency’s internal industry experts. 

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 Healthcare Waste Institute (HWI), 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. 

3(d) Effects of Less Frequent Collection

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.
6

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 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 (CBI) (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 for the respondents 

affected by the standards and the corresponding North American Industry Classification System

(NAICS) codes are listed below for the HMIWI source category. Not all processes classified in 

these NAICS codes are subject to the emission guidelines. 

Standard (40 CFR Part 60, Subpart Ce and 

40 CFR Part 62, Subpart HHH)

SIC Codes NAICS Codes

General Medical and Surgical Hospitals 8062, 8069 622110

Specialty Hospitals 8069 622310
7

Standard (40 CFR Part 60, Subpart Ce and 

40 CFR Part 62, Subpart HHH)

SIC Codes NAICS Codes

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

3721, 3724, 3728, 3761, 

3764, 3769, 8731, 8733

541710

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). 

A source must make the following reports:

Notifications

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)

Installation of CMS 60.37(e), 60.56(c), 60.57(c) 

62.14454

Initial and repeat performance specification tests for CMS 60.37(e), 60.56(c), 60.57(c), 

62.14454(f)

Initial equipment inspection (small rural HMIWI) 60.37(b), 60.56(c), 60.57(c), 

62.14440

Increments of progress for HMIWI that will comply with 

regulation 60.39e(c)

Request for extension to shut down late 60.39e(d)
8

Notifications

Waste management plan 60.35e, 60.353(a), 60.38e(a), 

60.55c(c), 60.58c(c), 62.14430

Notification of HMIWI capacity 60.58c(a)

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

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)

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

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)

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), 62.14463(a)

Initial report of values for site-specific operating parameters 60.38e(a), 60.58c(c), 

62.14463(f)

Annual report of values for site-specific operating 

parameters

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

62.14463(d) – (f)

Annual report of the highest maximum and lowest 

minimum operating parameters (covering the last two 

years)

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

62.14463(d)

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(cd), 62.14463(g), 62.14464(b-c)

Annual report containing results of annual performance test 60.38e(a-b), 60.58c(d), 

62.14463(h), 62.14464(b)

Annual report of no excess emissions, malfunctions, or 

operating parameter exceedances

60.38e(a), 60.58c(d), 60.7(c), 

62.14463(i)

Results of previous performance tests 60.37e(f), 60.38e(a)

Any use of the bypass stack, duration, reason for 

malfunction, and corrective action taken

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

62.14463(j)

Annual update of operating information 60.34(e), 60.53c(i), 62.14423(c)
9

Notifications

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

62.14461

Records of startup, shutdown, or malfunction 60.38e(a), 60.57c, 60.7(b), 

62.14460(d)

Records of initial performance test 60.37e, 60.57c, 62.14460(a)

Records of CMS operation and maintenance 60.38e(a), 60.57c, 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)

Records on a quarterly basis of periods, when only 

pathological, low-level radioactive, and/or 

chemotherapeutical waste is burned.

60.32e(b-c), 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), 60.58c(b), 

62.14460(g)

Records of operators completing operator training course 

and qualification requirements

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

62.14460(h)

Records of operators who have met the qualification 

requirements

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

62.14460(h-i)

Records of calibration of any monitoring devices 60.38e(a), 60.58c(b), 

62.14460(j)
10

Recordkeeping 

Records of emissions, process, and control device operating 

parameters

60.38e(a), 60.58c(b), 60.8(f), 

62.14460(a) and (b)(2-12)

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. 

Also, regulatory agencies in cooperation with the respondents continue to create reporting 

systems to transmit data electronically. However, electronic reporting systems are still not 

widely used. At this time, it is estimated that approximately 15 percent of the respondents use 

electronic reporting.

(ii) Respondent Activities

Respondent Activities

Read instructions.

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.

Prepare and review reports of performance tests and CMS demonstrations.

Submit the required reports developing, acquiring, installing, and utilizing technology and 
11

Respondent Activities

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.

Currently, sources are using monitoring equipment and reporting equipment that provides 

parameter data in an automated way (e.g., continuous parameter monitoring system). Although 

personnel at the source still need to evaluate the data, this type of monitoring equipment has 

significantly reduced the burden associated with monitoring and recordkeeping.

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. 
12

Performance test reports are used by the Agency to discern a source’s initial capability to comply 

with the 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 entered into OTIS which is operated and 

maintained by EPA's Office of Compliance. OTIS is EPA’s database for the collection, 

maintenance, and retrieval of compliance data for approximately 125,000 industrial and 

government-owned facilities. EPA uses the OTIS 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. 

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. Wherever appropriate, specific tasks 

and major assumptions have been identified. Responses to this information collection are 
13

mandatory.

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 60,080 hours (Total Labor Hours from Table 1

below). These hours are based on Agency studies and background documents from the 

development of the regulation, Agency knowledge and experience with part 60 and part 62 

regulations, the previously approved ICR, and any comments received.

6(b) Estimating Respondent Costs

(i) Estimating Labor Costs

This ICR uses the following labor rates: 

Industry State Government

Managerial $120.77 ($57.51 + 110%) $66.98 ($41.86 + 60%)

Technical $99.39 ($47.33 + 110%) $52.13 ($32.58 + 60%)

Clerical $50.04 ($23.83 + 110%) $24.35 ($15.22 + 60%)

The industry rates are from the United States Department of Labor, Bureau of Labor Statistics, 

December 2011, “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. Rates for the State 

government are from the United States Department of Labor, Bureau of Labor Statistics, May 

2011 National Industry-Specific 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. 

(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
14

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 47 $562,000

- Federally owned 

HMIWI $3,700 0 $0 $8,317 6 $49,900

- State/locally-owned 

HMIWI $3,700 0 $0 $6,275 4 $25,100

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 $358

- Privately-owned 

HMIWI N/A 0 $0 $50.28 47 $2,363

- Federally owned 

HMIWI N/A 0 $0 $49.67 6 $298

- State/locally-owned 

HMIWI N/A 0 $0 $49.50 4 $198

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

- Privately-owned 

HMIWI N/A 0 $0 $1,800 47 $84,600

- Federally owned 

HMIWI N/A 0 $0 $1,800 6 $10,800

- State/locally-owned 

HMIWI N/A 0 $0 $1,800 4 $7,200

Subtotals

- States $0 $358

- Privately-owned 

HMIWI $0 $648,963

- Federally owned 

HMIWI $0 $60,998

- State/locally-owned 

HMIWI $0 $32,498

TOTAL $742,817

Note: 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 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.
15

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

above table. 

The total operation and maintenance (O&M) costs for this ICR are $742,817. 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 $742,817. 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 

$131,043. 

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

Managerial $62.27 (GS-13, Step 5, $38.92 + 60%) 

Technical $46.21 (GS-12, Step 1, $28.88 + 60%)

Clerical $25.01 (GS-6, Step 3, $15.63 + 60%)

These rates are from the Office of Personnel Management (OPM), 2011 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

79 existing respondents (47 privately-owned, 6 Federally-owned, and 4 State/locally-owned

HMIWI residing in 22 States, plus the individual 22 states.) 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 79 per year. 

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

years covered by this ICR. 
16

Number of Respondents

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 79 0 0 79

2 0 79 0 0 79

3 0 79 0 0 79

Average 0 79 0 0 79

1

New respondent 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 79. 

The total number of annual responses per year is calculated using the following table: 
17

(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 47 6 4 57

Exceedances, malfunctions, and 

periods for which data not 

obtained

0 9.4 1.2 0.8 11.4

Results of performance tests 

conducted during the year 0 47 6 4 57

Report of no exceedances 0 37.6 4.8 3.2 45.6

Report of annual equipment 

inspection (small rural HMIWI) 0 2 0 0 2

Semiannual report of exceedances, 

malfunctions, and periods for which 

data not obtained3

0 9.4 1.2 0.8 11.4

Total 22 152.4 19.2 12.8 206.4

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. 

The number of Total Annual Responses is approximately 206 (rounded), (22 for States, 

152.4 for privately-owned HMIWI, 19.2 for Federally-owned HMIWI, and 12.8 for State/locally 

owned HMIWI.

The total annual labor costs are $5,746,349. 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, respectively, and summarized below. 
18

(i) Respondent Tally

The total annual labor hours are 60,080. 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). 

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

information is estimated to average 292 (rounded) hours per response.

The total annual capital/startup and O&M costs to the regulated entity are $742,817. 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 

2,908 labor hours at a cost of $131,043. See below 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(f) Reasons for Change in Burden

There is a decrease in the total estimated burden as currently identified in the OMB 

Inventory of Approved Burdens. The decrease is not due to any program changes. The most 

recently approved ICR (ICR 1899.06) estimated the total burden associated with the regulation 

by adding together the burdens and costs from the ICR for the existing standard (ICR 1899.05) 

and the revised standard (ICR 2335.02); portions of the rule requirements and burden activities 

in ICRs 1899.06 and 2335.02 overlap. This ICR updates all estimates and removes any duplicate 

burdens. 

There is no capital/startup cost associated with this ICR, which is a decrease from the 

most recently approved ICR. There are also changes in the O&M costs in this ICR compared to 

the previous ICR. These changes occurred because the most recently revised standard has been 

in effect for more than three years and the requirements are different during initial compliance as 

compared to on-going compliance. This ICR does not include the costs and burden for 

conducting initial compliance tests and notifications. Additionally, this ICR assumes that all 

sources have already purchased monitoring and testing equipment to comply with the standard. 

6(g) Burden Statement

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

is estimated to average 292 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, 
19

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) 566-1752. 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.
20

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) 

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 (States)

 A. Read instructions 1 1 1 0 0 0 0 $0 

 B. Required activities c

- 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 $25,481.28 

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

 C. Create information Incl. in 3B

 D. Gather information Incl. in 3B

 E. Write report

- State Plan/Inventory Incl. in 3B

- Annual update of State Plan Inventory Incl. in 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) 506 $25,481.28

4. Reporting requirements (privately-owned HMIWI)

 A. Read instructions d

40 1 40 0 0 0 0 $0 

 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 

 Repeat performance specification tests/CMS 8 1 8 0 0 0 0 $0 

 Initial equipment inspection (small rural HMIWI) 20 1 20 0 0 0 0 $0 

 Annual update of operating information f

20 1 20 47 940 47 94 $103,806.55 

 Review operating information with each operator g

8 2 16 47 752 37.6 75.2 $83,045.24 

 Annual equipment inspection (small rural HMIWI) 20 1 20 2 40 2 4 $4,417.30 

 Annual equipment inspection (all other HMIWI) 20 1 20 45 900 45 90 $99,389.25 
21

 C. Create information See 3B

 Development of operating information h

160 1 160 0 0 0 0 $0 

 D. Gather information Incl. in 4B

 E. Write report e

 Increments of progress for HMIWI that will Comply

 Control plan 24 1 24 0 0 0 0 $0 

 Notification of construction contracts 2 1 2 0 0 0 0 $0 

 Notification of construction commencement 2 1 2 0 0 0 0 $0 

 Notification of construction completion 2 1 2 0 0 0 0 $0 

 Notification of control plan completion 2 1 2 0 0 0 0 $0 

 Request for extension to shut down date 12 1 12 0 0 0 0 $0 

 Notification of initial performance test 2 1 2 0 0 0 0 $0 

 Notification of initial CMS demonstration 2 1 2 0 0 0 0 $0 

 Waste management plan i

160 1 160 0 0 0 0 $0 

 Report of initial performance test for PM, CO, Hg, dioxins/furans, and stack opacity (small 

rural HMIWI) 560 1 560 0 0 0 0 $0 

 Report of initial performance test for PM, CO, HCI, dioxins/furans, metals, and stack opacity 

(small non-rural, medium, and large HMIWI) 640 1 640 0 0 0 0 $0 

 Report of initial CMS demonstration See 4B

 Annual report 

 CMS operating parameters 32 1 32 47 1,504 75.2 150.4 $166,090.48

 Emissions/parameter exceedances and periods when emission/parameter data not obtained j

- Small rural HMIWI 16 1 16 0.4 6.4 0.32 0.64 $706.77

- All other HMIWI 64 1 64 9 576 28.8 57.6 $63,609.12

 Report of annual performance test 

- Small rural HMIWI 20 1 20 2 40 2 4 $4,417.30

- All other HMIWI 280 1 280 45 12,600 630 1,260 $1,391,449.50

 Report of no exceedances

- Small rural HMIWI 8 1 8 1.6 13 0.65 1.3 $1,413.54

- All other HMIWI 32 1 32 36 1,152 57.6 115.2 $127,218.24

 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 32 2 64 9 576 28.8 57.6 $63,609.12 

 Semiannual report of emissions/parameter exceedances and periods when emission/parameter 

data not obtained (small rural HMIWI) j 8 2 16 0.4 6.4 0.32 0.64 $706.77 

Subtotal for Reporting Requirements (Privately-owned HMIWI) 21,971 $2,109,879.17
22

5. Reporting requirements (Federally-owned HMIWI)

 A. Read instructions e1 1 1 0 0 0 0 $0 

 B. Required activities

 Annual update of operating information f20 1 20 6 120 6 12 $13,251.90 

 Review operating information with each operator g8 2 16 6 96 4.8 9.6 $10,601.52 

 Annual control equipment inspection 20 1 20 6 120 6 12 $13,251.90 

 C. Create information NA

 D. Gather existing information Incl. in 5B

 E. Write report

 Annual report 

 CMS operating parameters 32 1 32 6 192 9.6 19.2 $21,203.04 

 Emissions/parameter exceedances and periods when emission/parameter data not obtained j64 1 64 1.2 76.8 3.84 7.68 $8,481.22 

 Report of annual performance test 40 1 40 6 240 12 24 $26,503.80 

 Report of no exceedances 32 1 32 4.8 153.6 7.68 15.36 $16,962.43 

 Report of annual equipment inspection Incl. in 5B

 Semiannual report of emissions/parameter exceedances and periods when emission/parameter 

data not obtained j 32 2 64 1.2 76.8 3.84 7.68 $8,481.22 

Subtotal for Reporting Requirements (Federally-owned HMIWI) 1,236 $118,737.02

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

 A. Read instructions e1 1 1 0 0 0 0 $0 

 B. Required activities 0 0 0 $0 

 Annual update of operating information 20 1 20 4 80 4 8 $8,834.60 

 Review operating information with each operator 8 2 16 4 64 3.2 6.4 $7,067.68 

 Annual control equipment inspection 20 1 20 4 80 4 8 $8,834.60 

 C. Create information NA

 D. Gather existing information Incl. in 6B

 E. Write report

 Annual report 

 CMS operating parameters 32 1 32 4 128 6.4 12.8 $14,135.36 

 Emissions/parameter exceedances and periods when emission/parameter data not obtained j64 1 64 0.8 51.2 2.56 5.12 $5,654.14 

 Report of annual performance test 40 1 40 4 160 8 16 $17,669.20 

 Report of no exceedances j

32 1 32 3.2 102.4 5.12 10.24 $11,308.29 

 Report of annual equipment inspection Incl. in 6B

 Semiannual report of emissions/parameter exceedances and periods when emission/parameter 

data not obtained j 32 2 64 0.8 51.2 2.56 5.12 $5,654.14 

Subtotal for Reporting Requirements (State/locally-owned HMIWI) 824 $79,158.02
23

7. Reporting requirements (co-fired combustors and pathological/low-level 

radioactive/chemotherapeutic waste combustors)

 A. Read instructions N/A

 B. Required activities N/A

 C. Create information N/A

 D. Gather existing information N/A

 E. Write report

 Notification of exemption claim 2 1 2 0 0 0 0 $0 

 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) 0 $0

8. Recordkeeping requirements (States)

 A. Read instructions NA

 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. Read instructions N/A

 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 47 3,666 183.3 366.6 $404,845.55 

 Records of persons reviewing operating information r 2 2 4 47 188 9.4 18.8 $20,761.31 

 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 2 52 2.6 5.2 $5,742.49 

- All other HMIWI 1.5 52 78 45 3,510 175.5 351 $387,618.08 

 Records of CMS operation and maintenance
24

- Small rural HMIWI 0.5 250 125 2 250 12.5 25 $27,608.13 

- All other HMIWI 1.5 250 375 45 16,875 843.75 1,688 $1,863,548.44

 Records of emissions/parameter exceedances and periods when emission/parameter data not 

obtained j

- Small rural HMIWI 0.5 52 26 0.4 10.4 0.52 1.04 $1,148.50 

- All other HMIWI 1.5 52 78 9 702 35.1 70.2 $77,523.62 

 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) 29,042 $2,788,796.10

10. Recordkeeping requirements (Federally-owned HMIWI)

 A. Read instructions N/A

 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 6 468 23.4 46.8 $51,682.41 

 Records of persons reviewing operating information 2 2 4 6 24 1.2 2.4 $2,650.38 

 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 6 468 23.4 46.8 $51,682.41 

 Records of CMS operation and maintenance 1.5 250 375 6 2,250 112.5 225 $248,473.13 

 Records of emissions/parameter exceedances and periods when emission/parameter data not 

obtained j 1.5 52 78 1.2 93.6 4.68 9.36 $10,336.48 

 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

Subtotal for Recordkeeping Requirements (Federally-owned HMIWI) 3,799 $364,824.81

11. Recordkeeping requirements (State/locally-owned HMIWI)

 A. Read instructions N/A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A
25

 E. Time to enter information

 Records of startup, shutdown, malfunction 1.5 52 78 4 312 15.6 31.2 $34,454.94 

 Records of persons reviewing operating information r 2 2 4 4 16 0.8 1.6 $1,766.92 

 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 4 312 15.6 31.2 $34,454.94 

 Records of CMS operation and maintenance 1.5 250 375 4 1,500 75 150 $165,648.75 

 Records of emissions/parameter exceedances and periods when emission/parameter data not 

obtained j 1.5 52 78 0.8 62.4 3.12 6.24 $6,890.99 

 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

Subtotal for Recordkeeping Requirements (State/Locally-owned HMIWI) 2,533 $243,216.54

12. Recordkeeping requirements (co-fired and pathological/low-level radioactive/ 

chemotherapeutic combustors) 

 A. Read instructions N/A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A

 E. Time to enter information

 Quarterly records of periods when only pathological, low-level radioactive, chemotherapeutic 

waste burned k 2 4 8 13.4 107.2 5.36 10.72 $11,838.36 

 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 $4,417.30 

Subtotal for Recordkeeping Requirements (Co-fired and pathological/low level radioactive / 

chemotherapeutic combustors) 169 $16,255.66

 F. Time to train personnel N/A

 G. Time for audits N/A

TOTAL REPORTING REQUIREMENTS (FROM SUBTOTALS) 24,537 $2,333,255

TOTAL RECORDKEEPING REQUIREMENTS (FROM SUBTOTALS) 35,543 $3,413,093

TOTAL LABOR BURDEN AND COST (ROUNDED) 60,080 $5,746,349
26

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 79 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years. 

The breakdown is as follows: 47 privately-owned HMIWI (including 2 small rural HMIWI), 6 Federally-owned HMIWI, and 4 State/locally-owned HMIWI, and 22 

States that require annual State Plan Inventory.

b

 This ICR uses the following labor rates for industry: $120.77 per hour for Executive, Administrative, and Managerial labor; $99.39 per hour for Technical labor, 

and $50.04 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2011 “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: $66.98 for Managerial 

labor; $52.13 for Technical labor, and $24.35 for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, May 2011 

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

 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. 

d We have assumed that it will take 40 hours for each new respondent to read requirements.

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.

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.
27

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, lowlevel 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 

 Review notification of initial performance test 8 1 8 0 0 0 0 $0 

 Review notification of initial CMS demonstration 5 1 5 0 0 0 0 $0 

 Review report of initial performance test 36 1 36 0 0 0 0 $0 

 Review report of initial CMS demonstration 24 1 24 0 0 0 0 $0 

 Review annual report

 CMS operating parameters

- Small rural HMIWI 2 1 2 2 4 0.2 0.4 $207.30 

- All other HMIWI 6 1 6 55 330 16.5 33 $17,102.09 
28

Emissions/parameter exceedances and periods when 

emission/parameter data not obtained c

- Small rural HMIWI 4 1 4 0.4 1.6 0.08 0.16 $82.92 

- All other HMIWI 16 1 16 11 176 8.8 17.6 $9,121.11 

 Results of annual performance test

- Small rural HMIWI 6 1 6 2 12 0.6 1.2 $621.89 

- All other HMIWI 24 1 24 55 1,320 66 132 $68,408.34 

 Report of no exceedances 

- Small rural HMIWI 2 1 2 1.6 3.2 0.16 0.32 $165.84 

- All other HMIWI 8 1 8 44 352 17.6 35.2 $18,242.22 

 Review semiannual report of emissions/ parameter exceedances 

and periods when emission/parameter data not obtained c

- Small rural HMIWI 2 1 2 0.4 0.8 0.04 0.08 $41.46 

- All other HMIWI 8 1 8 11 88 4.4 8.8 $4,560.56 

 Report of annual equipment inspection (Small rural HMIWI) 4 1 4 2 8 0.4 0.8 $414.60 

 Report of annual control equipment inspection (All other 

HMIWI) 4 1 4 0 0 0 0 $0 

 G. Review reports for States

 Review annual update of State Plan Inventory d

8 1 8 22 176 8.8 17.6 $9,121.11 

4. Prepare annual summary report e

1 1 1 57 57 2.9 5.7 $2,954.00 

TOTAL ANNUAL BURDEN AND COST 2,908 $131,043.43 

Assumptions:

 a

 We have assumed that there are approximately 57 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three 

years. The 57 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: $62.27 for 

Managerial (GS-13, Step 5, $38.92 x 1.6), $46.21 for Technical (GS-12, Step 1, $28.88 x 1.6) and $25.01 Clerical (GS-6, Step 3, $15.63 x 1.6). These rates are 

from the Office of Personnel Management (OPM) “2011 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.