SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) 

(Renewal)

1. Identification of the Information Collection

1(a) Title of the Information Collection

NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec)

(Renewal), EPA ICR Number 1730.10, OMB Control Number 2060-0363.

1(b) Short Characterization/Abstract

The New Source Performance Standards (NSPS) for Hospital/Medical/Infectious Waste 

Incinerators (HMIWI) were promulgated on September 15, 1997, and amended on October 6, 

2009 and February 27, 2014. The original standards applied to owners or operators of HMIWI

for which construction commenced after June 20, 1996, or for which modification commenced 

after March 16, 1998, but no later than April 6, 2010. Sources subject to the original standards 

are now covered under the revised Emission Guidelines for HMIWI at 40 CFR Part 60, Subpart 

Ce. This information request covers the reporting and recordkeeping requirements associated 

with the revised NSPS, which apply to new facilities only. New facilities include those that 

commenced construction after December 1, 2008 or commenced modification after April 6, 

2010. The 2014 amendment corrected a spelling error in the definition of medical/infectious 

wastes, and does not impact the burden estimates in this ICR. This information is being collected 

to assure compliance with 40 CFR Part 60, Subpart Ec.

In general, all NSPS standards require initial notifications, performance tests, and 

periodic reports by the owners/operators of the affected facilities. They are also required to 

maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the 

operation of an affected facility, or any period during which the monitoring system is 

inoperative. These notifications, reports, and records are essential in determining compliance, 

and are required of all affected facilities subject to NSPS.

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.

The “Affected Public” is owners and operators of HMIWI subject to the revised NSPS.

The burden to the “Affected Public” may be found in Table 1: Annual Respondent Burden and 

Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) 

(Renewal). The “Federal Government” burden is attributed entirely to work performed by federal 

employees or government contractors and may be found in Table 2: Average Annual EPA 

Burden and Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, 
2

Subpart Ec) (Renewal). 

Based on our consultations with industry representatives, there is an average of one

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 eight respondents per year will be subject to the 

standard, and one additional respondents per year will become subject to the standard. This is 

based on the Agency’s estimated industry growth rate from a previous renewal. 

The previous ICR had the following Terms of Clearance (TOC): 

When this ICR is renewed, EPA should review the respondent burden, 

universe, labor rates, and capital costs and ensure these estimates have been 

updated. 

The EPA has addressed each item of concern in the TOC by consulting with industry and 

updating the labor rates in calculating all cost burdens.

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

The EPA is charged under Section 111 of the Clean Air Act (CAA), as amended, to 

establish standards of performance for new stationary sources that reflect: 

. . . application of the best technological system of continuous 

emissions reduction which (taking into consideration the cost of 

achieving such emissions reduction, or any non-air quality health 

and environmental impact and energy requirements) the 

Administrator determines has been adequately demonstrated.

Section 111(a)(l).

The Agency refers to this charge as selecting the best demonstrated technology (BDT). Section 

111 also requires that the Administrator review and, if appropriate, revise such standards every

four years. In addition, section 114(a) states that the Administrator may require any 

owner/operator subject to any requirement of this Act to: 

(A) Establish and maintain such records; (B) make such reports; 

(C) install, use, and maintain such monitoring equipment, and use 

such audit procedures, or methods; (D) sample such emissions (in 

accordance with such procedures or methods, at such locations, at 

such intervals, during such periods, and in such manner as the 

Administrator shall prescribe); (E) keep records on control 
3

equipment parameters, production variables or other indirect data 

when direct monitoring of emissions is impractical; (F) submit 

compliance certifications in accordance with Section 114(a)(3); 

and (G) provide such other information as the Administrator may

reasonably require.

In the Administrator's judgment, dioxin/furan, particulate matter (PM), carbon monoxide 

(CO), hydrogen chloride (HCl), sulfur dioxide (SO2), nitrogen oxides (NOx), lead (Pb), cadmium 

(Cd), and mercury (Hg) emissions from HMIWI cause or contribute to air pollution that may

reasonably be anticipated to endanger public health or welfare. Therefore, the NSPS were 

promulgated for this source category at 40 CFR Part 60, Subpart Ec.

2(b) Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard 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 standard. Continuous emission monitors are used to 

ensure compliance with the standard 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 standard 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 standard 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. Nonduplication, Consultations, and Other Collection Criteria

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

Ec.

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 
4

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’s industry experts have been consulted, and the Agency’s internal data 

sources and projections of industry growth over the next three years have been considered. 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 the EPA Office of Compliance. OTIS is the EPA 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. In developing 

this ICR, we contacted both St. Joseph’s Hospital, at (813) 870-4000, and the Wilkes-Barre 

General Hospital, at (570) 829-8111.

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

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 
5

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. The United States Standard Industrial Classification (SIC) codes for the 

respondents affected by the standards and their corresponding North American Industry

Classification System (NAICS) codes are listed in the table below.

Standard (40 CFR Part 60, Subpart Ec) SIC Codes NAICS Codes

General Medical and Surgical Hospitals 8062 622110

Specialty Hospitals 8069 622310

Medicinal and Botanical Manufacturing 2833 325411

Pharmaceutical Preparation Manufacturing 2834 325412

Solid Waste Combustors and Incinerators 4953 562213

Colleges, Universities, and Professional Schools 8221 611310

Research and Development in Physical, 

Chemical, and Life Sciences 8731, 8733 541710

National Security 9711 928110

Public Health Facility 9431 923120
6

4(b) Information Requested

(i) Data Items

In this ICR, all the data that is recorded or reported is required by the NSPS for 

Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec).

A source must make the following reports:

Notifications

Notification and application of construction or modification 60.58c(a), 60.7(a)

Notification of anticipated startup 60.58c(a), 60.7(a)

Notification of actual startup 60.7(a)

Notification of type(s) of waste to be combusted 60.58c(a)(2)(i)

Notification of HMIWI capacity 60.58c(a)(2)(ii)

Notification of initial continuous monitoring system (CMS) 

demonstration (including CO CEMS)

60.7(a)

Notification of initial performance test 60.8(d)

Notification of exemption claim for combustors burning pathological, 

low-level radioactive, and/or chemotherapeutic waste

60.50c(b)(1)

Notification of exemption claim for co-fired combustors 60.50c(c)(1)

Reports

Statement of intent to construct/modify 60.58c(a)(1)(i)

Documentation produced as a result of the siting requirements 60.58c(a)(1)(iv), 

60.54c(c)

Waste management plan 60.58c(c)(3), 

60.55c

Analysis and supporting documentation demonstrating conformance 

with EPA guidance and specifications for bag leak detection systems

60.58c(c)(4)

Report of initial performance tests 60.58c(d)(6), 

60.8(a)

Initial report of values for site-specific operating parameters 60.58c(c)(2), 

60.7(a)

Annual report of values for site-specific operating parameters 60.58c(d)(1)

Annual and semiannual reports of emissions or operating parameter 

exceedances, malfunctions, and periods for which data on 

60.58c(d), 
7

Reports

emissions/operating parameters were not obtained 60.58c(e), 60.7(c)

Annual report of no excess emissions 60.58c(d)(7), 

60.7(c)

Report of results of annual performance test 60.58c(d)(6)

Annual report of control equipment inspection 60.58c(d)

A source must keep the following records:

Recordkeeping

Retention of records for 5 years 60.58c(b)

Records of startup, shutdown, or malfunction 60.7(b)

Documentation produced as a result of siting requirements 60.58c(b)(7)

Records of operators completing review of HMIWI operating manual 60.58c(b)(8)

Records of operators completing operator training course and 

qualification requirements

60.58c(b)(9)-(10)

Records of initial and annual testing of fugitive ash emissions 60.58c(b)(2)(ii)

Records of process and control device operating parameters 60.58c(b)(2)(iii)(xi

x)

Records of CMS operation and maintenance (including CO CEMS) 60.7(f)

Records of emissions or operating parameter exceedances, malfunctions,

and periods for which data on emissions/operating parameters were not 

obtained

60.58c(b)(3)-(5)

Records of initial, annual, and any subsequent performance tests 60.58c(b)(6)

Records of calibration of monitoring devices (including CO CEMS) 60.58c(b)(11)

Records of annual control equipment inspections, required maintenance, 

and repairs not completed during established timeframe

60.58c(b)(2)(xvii)

Records of bag leak detection system alarms and corrective action taken 60.58c(b)(2)(xviii)

Records of CO concentrations from CO CEMS 60.58c(b)(2)(xix)

Records on quarterly basis of types and amounts of materials charged for 

co-fired combustors and for incinerators burning only pathological, lowlevel radioactive, and/or chemotherapeutical waste

60.50c(b), (c)

Electronic Reporting

Some of the respondents are using monitoring equipment that automatically records 
8

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.

(ii) Respondent Activities

Respondent Activities

Familiarization with the regulatory requirements.

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

supply pressure for control device.

Perform initial performance test and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

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

systems for 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.

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

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

Review notifications and reports, including performance test reports, and excess emissions 

reports, required to be submitted by industry.
9

Agency Activities

Audit facility records.

Input, analyze, and maintain data in the Enforcement and Compliance History Online (ECHO) 

and ICIS. 

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 

emission standard, and note the operating conditions under which compliance was achieved.

Data and records maintained by the respondents are tabulated and published for use in 

compliance and enforcement programs. The semiannual reports are used for problem 

identification, as a check on source operation and maintenance, and for compliance 

determinations.

Information contained in the reports is reported by state and local governments in the 

ICIS Air database, which is operated and maintained by EPA's Office of Compliance. 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

There are no small entities (i.e., small businesses) affected by this regulation. However, 

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

development of 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. 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 – NSPS for 

Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
10

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 the subpart included in this ICR. The 

individual burdens are expressed under standardized headings believed to be consistent with the 

concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and 

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

The 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 5,670 (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 NSPS 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 standard 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
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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)

DIFF/WS $1,233 1 $1,233 $4,733 8 $37,864 

DIFF $967 1 $967 $2,733 8 $21,864 

WS $1,233 1 $1,233 $1,133 8 $9,064 

SNCR $1,400 1 $1,400 $300 8 $2,400 

CO CEMS $17,500 1 $17,500 $25,100 8 $200,800 

BLD $1,033 1 $1,033 $1,267 8 $10,136 

ACI $0 1 $0 $3,367 8 $26,936 

Testing $67,458 1 $67,458 $0 8 $0 

Filing Cabinets $100 1 $100 $0 8 $0 

Photocopying $0 1 $0 $199 8 $1,592 

Postage $0 1 $0 $93 8 $744 

TOTAL $90,900 $311,000 

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

The total capital/startup costs for this ICR are $90,900. This is the total of column D in 

the above table. 

The total operation and maintenance (O&M) costs for this ICR are $311,000. 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 $402,000.

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 

$22,200.

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%)
12

These rates are from the Office of Personnel Management (OPM), 2015 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 – NSPS for 

Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (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

seven existing respondents will be subject to the standard. It is estimated that an additional one

respondents per year will become subject. The overall average number of respondents, as shown 

in the table below, is eight per year.

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 1 6 0 0 7

2 1 7 0 0 8

3 1 8 0 0 9

Average 1 7 0 0 8

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 eight. 

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

Total Annual Responses

(A)

Information Collection Activity

(B)

Number of 

Respondents

(C)

Number of 

Responses

(D)

Number of Existing 

Respondents That 

Keep Records But Do 

Not Submit Reports

(E)

Total Annual

Responses

E=(BxC)+D

Notification of intent to construct 1 1 N/A 1
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Total Annual Responses

Notification of anticipated 

commencement of construction 1 1 N/A 1

Notification of anticipated startup 1 1 N/A 1

Notification of actual startup 1 1 N/A 1

Notification of type(s) of waste to be 

combusted 1 1 N/A 1

Notification of HMIWI capacity 1 1 N/A 1

Notification of initial performance test 1 1 N/A 1

Notification of initial CMS 

demonstration 1 1 N/A 1

Initial report for the site selection 

analysis 1 1 N/A 1

Waste management plan 1 1 N/A 1

Analysis and supporting documentation 

demonstrating conformance with EPA 

guidance and specifications for bag leak 

detection systems1

0.67 1 N/A 0.67

Report of initial performance test 1 1 N/A 1

Report of initial CMS demonstration 1 1 N/A 1

Annual report

CMS emissions and operating 

parameters 8 1 N/A 8

Exceedances, malfunctions, and periods 

for which data not obtained2 1.6 1 N/A 1.6

Results of performance tests conducted 

during the year 8 1 N/A 8

Report of no exceedances26.4 1 N/A 6.4

Report of annual control equipment 

inspection 8 1 N/A 8

Semiannual report of exceedances, 

malfunctions, and periods for which 

data not obtained 2

1.6 1 N/A 1.6

Total (rounded) 46

1 Assume the total number of sources will be evenly distributed among small, medium, and large sources 

and only new large and medium sources (i.e. two-thirds of the effected sources) will install baghouses.

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

emissions.

The number of Total Annual Responses is 46

The total annual labor costs are $570,000. Details regarding these estimates may be found 

below in Table 1: Annual Respondent Burden and Cost – NSPS for Hospital/Medical/Infectious 
14

Waste Incinerators (40 CFR Part 60, Subpart Ec) (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.

(i) Respondent Tally

The total annual labor hours are 5,670. Details regarding these estimates may be found in 

Table 1: Annual Respondent Burden and Cost – NSPS for Hospital/Medical/Infectious Waste 

Incinerators (40 CFR Part 60, Subpart Ec) (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 123 hours per response.

The total annual capital/startup and O&M costs to the regulated entity are $402,000. 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 488 

labor hours at a cost of $22,200. See Table 2: Average Annual EPA Burden and Cost – NSPS for 

Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (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 increase in burden in this ICR from the most recently approved ICR. 

This is due to an increase in the estimated number of sources subject to the regulation, and is not 

caused by program changes. We estimate the industry will continue to grow at the rate of one 

new source per year. This results in increases in the respondent labor hours, number of 

responses, and capital/O&M costs. 

6(g) Burden Statement
15

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

is estimated to average 123 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-2012-0502. 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-2012-0502 and OMB Control Number 2060-0363 in any

correspondence. 

Part B of the Supporting Statement

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

information.
16

Table 1: Annual Respondent Burden and Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, 

Subpart Ec) (Renewal)

Burden item

(A)

Person 

hours per 

occurrence

(B)

No. of 

occurrences 

per 

respondent 

per year

(C)

Person 

hours per 

respondent 

per year

(C=AxB)

(D)

Respondent

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

 A. Familiarization with the regulatory

requirement 1 1 1 8 8 0.4 0.80 $925.16 

 B. Required activities

 Perf spec tests (certif) for CMS 16 1 16 1 16 0.80 1.60 $1,850.33 

 Repeat perf spec tests (certif) for CMS c,d 16 1 16 0 0 0 0 $0.00 

 Development of operating information e160 1 160 1 160 8 16 $18,503.28 

 Annual update of operating information f20 1 20 8 160 8 16 $18,503.28 

 Review of operating information with each 

operator g,h 8 2 16 8 128 6.4 12.8 $14,802.62 

 Initial control equipment inspection i20 1 20 1 20 1 2 $2,312.91 

 Annual control equipment inspection i20 1 20 8 160 8 16 $18,503.28 

 C. Create information See 3B

 D. Gather existing information See 3B

 E. Write reports

 Notification of intent to construct f2 1 2 1 2 0.10 0.20 $231.29 

 Notification of anticipated commencement of 

construction g 2 1 2 1 2 0.10 0.20 $231.29 

 Notification of anticipated startup g2 1 2 1 2 0.10 0.20 $231.29 
17

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)

Respondent

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

 Notification of actual startup g2 1 2 1 2 0.10 0.20 $231.29 

 Notification of type(s) of waste to be 

 combusted 2 1 2 1 2 0.10 0.20 $231.29 

 Notification of HMIWI capacity 2 1 2 1 2 0.10 0.20 $231.29 

 Notification of initial performance test h2 1 2 1 2 0.10 0.20 $231.29 

 Notification of initial CMS demonstration 2 1 2 1 2 0.10 0.20 $231.29 

 Initial report for the site selection analysis j460 1 460 1 460 23 46 $53,196.93 

 Waste management plan k160 1 160 1 160 8 16 $18,503.28 

 Analysis and supporting documentation 

demonstrating conformance with EPA guidance 

and specifications for bag leak detection 

systems l

40 1 40 0.67 26.67 1.33 2.67 $3,083.88 

 Report of initial performance test m8 1 8 1 8 0.40 0.80 $925.16 

 Report of initial CMS demonstration mSee 3B

 Annual report

 CMS emissions/operation parameters n32 1 32 8 256 12.8 25.6 $29,605.25 

 Exceedances/ malfunctions/periods of 

 which data not obtained q,p 48 1 48 1.6 76.8 3.84 7.68 $8,881.57 

 Results of performance tests conducted 

 during the year q 40 1 40 8 320 16 32 $37,006.56 

 Report of no exceedances q,p 24 1 24 6.4 153.6 7.68 15.36 $17,763.15 

 Report of annual control equipment 

 inspection See 3B

 Semiannual report of exceedances/ 

 malfunctions/periods for which data not 

 obtained q,p,r

48 1 48 1.6 76.8 3.84 7.68 $8,881.57 
18

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)

Respondent

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

Subtotal for Reporting Requirements 2,537 $255,099

4. Recordkeeping requirements

 A. Familiarize with regulatory requirement See 3A

 B. Plan activities N/A

 C. Implement activities N/A

 D. Develop record system N/A

 E. Time to enter information

 Documentation produced as a result of sitting 

requirements See 3E

 Records of operators completing operator 

training requirements h 2 2 4 1 4 0.20 0.40 $462.58 

 Records of operators that have been qualified 

as HMIWI operators h 2 2 4 1 4 0.20 0.40 $462.58 

 Records of initial performance test See 3E

 Records of startup, shutdown, or malfunction 1.5 52 78 8 624 31.2 62.4 $72,162.79 

 Records of persons completing review of 

operating information h 2 2 4 8 32 1.6 3.2 $3,700.66 

 Records of process and control device 

operating parameters 1.5 52 78 8 624 31.20 62.4 $72,162.79 

 Records of CMS operation and maintenance g0.03 365 9.13 8 73.00 3.65 7.30 $8,442.12 

 Records of exceedances/ malfunctions/periods 

for which data not obtained 1.5 52 78 8 624 31.2 62.4 $72,162.79 

 Records of annual and any subsequent 

compliance tests See 3E

 Records of annual control equipment See 3B
19

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)

Respondent

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

inspections

 Records of bag leak detection system alarms l1.5 52 78 5.33 416 20.80 41.60 $48,108.53 

 F. Time to train personnel t40 1 40 8 320 16 32 $37,006.56 

 F. Time for audits N/A

Subtotal for Recordkeeping Requirements 3,129 $314,671

TOTAL LABOR BURDEN AND COSTu5,670 $570,000 

Capital and O&M Cost (see Section 6(b)(iii)):u$402,000 

TOTAL COST: u$972,000 

Assumptions:

a We have assumed that the average number of sources that will be subject to the standard will be 5. There will be one additional new source per year that will 

become subject to the rule over the three-year period of this ICR 

b This ICR uses the following labor rates: $129.93 per hour for Executive, Administrative, and Managerial labor; $103.7 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.

c We assume that performance specification to certify CMS is expected to take approximately 16 hours.

d We assume no failures of the initial CMS demonstrations; includes CO CEMS.

e We assume it will take160 hrs to develop the operating information.

f We assume that it will take 20 hours to update the operating information each year.

g We assume that it will take 8 hours to review the operating information with each operator.

h We assume that it will take 2 operators per facility to enter information. Also assume there is no operator turnover at the affected facilities. 

i We assume that annual control equipment inspection will occur for all sources. 

j We assume that it will take 460 hours to develop the site selection analysis.
20

k We assume that it will take 160 hours to develop the waste management plan.

l We assume that it will take 40 hours to develop the bag leak detection system analysis and 1.5 hours to record bag leak detection system alarms. Assume the total 

number of sources will be evenly distributed among small, medium, and large sources and only new large and medium sources (i.e. two-thirds of the effected 

sources) will install baghouses.

m We assume that it will take 8 hours for each facility to review the report of the initial performance test for pollutants and fugitive ash.

n Person-hours per occurrence are assumed to be 32 hours.

o We have assume that it will take 48 hours and 24 hours per report per affected facility to report monitoring exceedances and no excess emissions, respectively.

Because testing and monitoring requirements focus primarily on three pollutants (PM, CO, and HCl), assume three pollutants.

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

q Assume 40 hours to review report of annual compliance test.

r Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods 

for which data were not obtained, the frequency of the semiannual report is shown in the table as only once per year to avoid double-counting.

s We assume that this activity will be recorded daily.

t We assumed that it will take 40 hours once per year to train one person to perform the Method 9 and Method 22 tests. The labor requirements to train the 

personnel were estimated to be 8 hr/d for 5 d/yr.

uTotals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.
21

Table 2: Average Annual EPA Burden and Cost – NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, 

Subpart Ec)

Activity

(A)

EPA 

Person 

hours per 

occurrence

(B)

No. of 

occurrences 

per 

respondent 

per year

(C)

Person 

hours per 

respondent 

per year

(C=AxB)

(D)

Respondents 

per year

a

(E)

Technical 

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. Attend initial performance test c32 1 32 0.08 2.56 0.13 0.26 $133.99 

2. Repeat performance test

A. Retesting preparation d12 1 12 0.2 2.4 0.12 0.24 $125.62 

B. Attend retesting e32 1 32 0.02 0.64 0.032 0.064 $33.50 

3. Litigation f N/A

4. Excess emissions--enforcement 

 activities g 32 1 32 0.02 0.64 0.032 0.064 $33.50 

5. Report review

 Review notification of intent to construct 2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of anticipated 

commencement of construction 

2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of anticipated startup 2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of actual startup 2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of type(s) of waste to 

be combusted 

2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of HMIWI capacity 2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of initial performance 

test 2 1 2 1 2 0.1 0.2 $104.68 

 Review notification of initial CMS 

demonstration 

2 1 2 1 2 0.1 0.2 $104.68 

 Review notification addressing sitting 

requirements 24 1 24 1 24 1.2 2.4 $1,256.16 

 Review waste management plan 8 1 8 1 8 0.4 0.8 $418.72 
22

Activity

(A)

EPA 

Person 

hours per 

occurrence

(B)

No. of 

occurrences 

per 

respondent 

per year

(C)

Person 

hours per 

respondent 

per year

(C=AxB)

(D)

Respondents 

per year

a

(E)

Technical 

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

 Review analysis for bag leak detection 

systems h 8 1 8 0.67 5.33 0.27 0.53 $279.15 

 Review report of initial performance test i54 1 54 1 54 2.7 5.4 $2,826.36 

 Review report of initial CMS demonstration N/A

 Review annual report

 CMS emissions/operating parameters j6 1 6 8 48 2.4 4.8 $2,512.32 

 Exceedances/malfunctions/periods for 

which data not obtained l 8 1 8 1.6 12.8 0.64 1.28 $669.95 

 Results of performance test conducted 

during the year l

 PM, CO, HCl 18 1 18 8 144 7.2 14.4 $7,536.96 

 Fugitive ash emissions 6 1 6 8 48 2.4 4.8 $2,512.32 

 Report of no exceedances m2 1 2 6.4 12.8 0.64 1.28 $669.95 

 Report of annual control equipment

inspection m 4 1 4 8 32 1.6 3.2 $1,674.88 

 Review semiannual report of exceedances/

malfunctions/periods for which data not 

obtained k,o

8 1 8 1.6 12.8 0.64 1.28 $669.95 

TOTAL ANNUAL BURDEN AND COST p488 $22,200

Assumptions:

a We have assumed that the average number of sources that will be subject to the standard will be 5. There will be one additional new source per year that will 

become subject to the rule over the three-year period of this ICR 

b This ICR uses the following labor rates: Managerial $62.90 (GS-13, Step 5, $39.31 + 60%) ; Technical $46.67 (GS-12, Step 1, $29.17 + 60%); and Clerical 

$25.25 (GS-6, Step 3, $15.78 + 60%). These rates are from the Office of Personnel Management (OPM), 2015 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.
23

c We assume EPA personnel attend 8 percent of the initial performance tests.

d We assume that 20 percent will fail the initial performance test, and will have to repeat the performance test. 

e We assume 10 percent of re-tests are attended by EPA personnel. 

f This ICR does not account for litigation costs.

g We assume 10 percent of the affected facilities are required to re-test as a result of excess emissions, and that EPA personnel attend 10 percent of these tests. 

h We assume only new large and medium sources will install baghouses. 

I We assume 6 person-hours per report per pollutant. For the three new HMIWI, nine pollutants are required to be tested. 

j We assume 1 person-hour per report per CMS. For HMIWI, assume each uses six CMS (flue gas temperature, secondary chamber temperature, charge weight, 

scrubber liquor pH, scrubber liquor flow, and scrubber energy input). 

k We assume 20 percent of the affected facilities with recurrent burden will report monitoring exceedances. 

l We assume 6 person-hours per report per pollutant. For annual tests, there are three pollutants (PM, CO, and HCl) for all HMIWI. 

m We assume 80 percent of the affected facilities with recurrent burden will report no excess emissions. 

n We assume it will take 4 hours to review the annual control equipment inspection report. 

o Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods 

for which data were not obtained, the frequency of semiannual report is shown in the table as only once per year to avoid double-counting. 

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